CD 008674

Immediate versus delayed reconstruction following surgery
for breast cancer (Review)

DSouza N, Darmanin G, Fedorowicz Z
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2011, Issue 7
http://www.thecochranelibrary.com
Immediate versus delayed reconstruction following surgery for breast cancer (Review)
Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
T A B L E O F C O N T E N T S
1 HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
10 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12 AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15 CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19 DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19 ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24 WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24 HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24 CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25 DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25 SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
25 INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
i Immediate versus delayed reconstruction following surgery for breast cancer (Review)
[Intervention Review]
Immediate versus delayed reconstruction following surgery
for breast cancer
Nigel DSouza
1
, Geraldine Darmanin
2
, Zbys Fedorowicz
3
1
Oxford Deanery, Heatherwood and Wexham Park Hospitals NHS Trust, Slough, UK.
2
London Deanery, Kings College Healthcare
Trust, London, UK.
3
UKCC (Bahrain Branch), Ministry of Health, Bahrain, Awali, Bahrain
Contact address: Nigel DSouza, Oxford Deanery, Heatherwood and Wexham Park Hospitals NHS Trust, Wexham Park Hospital,
Slough, Berkshire, SL2 4HL, UK. n.dsouza15@gmail.com.
Editorial group: Cochrane Breast Cancer Group.
Publication status and date: Edited (no change to conclusions), published in Issue 9, 2011.
Review content assessed as up-to-date: 25 August 2010.
Citation: DSouza N, Darmanin G, Fedorowicz Z. Immediate versus delayed reconstruction following surgery for breast cancer.
Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.: CD008674. DOI: 10.1002/14651858.CD008674.pub2.
A B S T R A C T
Background
Breast cancer is the most prevalent cancer in women and has a lifetime incidence of one in nine in the UK. Curative treatment requires
surgery, and may involve adjuvant and neo-adjuvant therapy. In many women, post-mastectomy breast reconstruction is essential to
restore body image and improve quality of life. Timing of reconstruction may be immediate or delayed following mastectomy. Outcomes
such as psychosocial morbidity, aesthetics and complications rates may differ between the two approaches.
Objectives
To assess the effects of immediate versus delayed reconstruction following surgery for breast cancer.
Search methods
We searched the Cochrane Breast Cancer Groups Specialised Register on 22 July 2010, MEDLINE fromJuly 2008 to 26 August 2010,
EMBASE from 2008 to 26 August 2010 and the WHO International Clinical Trials Registry Platform (ICTRP) on 26 August 2010.
Selection criteria
Randomised controlled trials (RCTs) comparing immediate breast reconstruction versus delayed or no reconstruction in women of any
age and stage of breast cancer. We considered any recognised methods of reconstruction to one or both breasts undertaken at the same
time as mastectomy or at any time following mastectomy.
Data collection and analysis
Two review authors independently screened papers, extracted trial details and assessed the risk of bias in the one eligible study.
Main results
We included only one RCT that involved 64 women. We judged this study as being at high risk of bias. Post-operative morbidity and
mortality were not addressed, and secondary outcomes of patient cosmetic evaluations and psychosocial well-being post-reconstruction
were inadequately reported. Based on limited data there was some, albeit unreliable, evidence that immediate reconstruction compared
with delayed or no reconstruction, reduced psychiatric morbidity reported three months post-operatively.
1 Immediate versus delayed reconstruction following surgery for breast cancer (Review)
Authors conclusions
The current level of evidence for the effectiveness of immediate versus delayed reconstruction following surgery for breast cancer was
based on a single RCT with methodological aws and a high risk of bias, which does not allow condent decision-making about
choice between these surgical options. Until high quality evidence is available, clinicians may wish to consider the recommendations
of relevant guidelines and protocols. Although the limitations and ethical constraints of conducting RCTs in this eld are recognised,
adequately powered controlled trials with a focus on clinical and psychological outcomes are still required. Given the paucity of RCTs
in this subject, in future versions of this review we will look at study designs other than RCTs specically good quality cohort and case-
control studies.
P L A I N L A N G U A G E S U M M A R Y
Immediate versus delayed reconstruction following surgery for breast cancer
Curative treatment of breast cancer requires surgery, which can involve a mastectomy to remove the entire breast. Breast reconstruction
following mastectomy can be carried out either immediately or as a delayed procedure. Immediate reconstruction is carried out at the
same time as surgery while delayed reconstruction may be performed at any time following mastectomy. Several non-randomised studies
have reported differences in the psychological benets, aesthetics and complication rates based on the timing of reconstruction. This
review sought to compare the effects of the timing of reconstruction on morbidity and mortality, patient satisfaction and psychosocial
well-being. Only one eligible randomised controlled trial (RCT) was found, which involved 64 women. However, because a substantial
number of participants in the study chose not to undergo delayed reconstruction, it was not possible to make a fair comparison of
the mixed group with those participants who underwent immediate reconstruction. Methodological aws and a high risk of bias also
diminished the quality of evidence found in the RCT. Since we have only identied one RCT in this area, an updated version of this
review will evaluate other study designs specically good quality cohort and case-control studies. Further research should aimto provide
reliable evidence for people to make informed decisions as to the best and most appropriate timing of breast reconstruction following
surgery for breast cancer.
B A C K G R O U N D
Description of the condition
Breast cancer is a malignant growth of cells originating in breast
tissue. It can spread to other parts of the body by growing into
adjacent tissues, or by breaking off and spreading via the blood-
stream or lymphatic system to seed into a distant organ or tissue,
where it may then begin to grow (metastatic spread). Metastatic
spread may occur in other organs, such as the liver, lung, brain and
bones. Data gathered by the International Agency for Research
on Cancer conrm that breast cancer is one of the most common
cancers in women, with 1.38 million newcases diagnosed in 2008.
Countries in the developed world have the highest age-standard-
ised incidence of breast cancer, which in Western Europe is 89.7
per 100,000 women and 76.7 per 100,000 in North America. Al-
though the incidence is lower in Eastern Europe, South America,
and Western Asia, it is still the most common cancer of women
in these geographic regions. In most of Africa, with the possible
exception of Southern Africa (41/100,000), the incidence rates are
generally lower, ranging from19.3 per 100,000 women in Eastern
Africa to 21 per 100,000 in Central Africa (GLOBOCAN 2008).
The lifetime risk in the UK for a woman to develop breast cancer
is one in nine. Over 81% of breast cancer occurs in women over
the age of 50, with the highest risk group category being 50 to 69
years (Ofce for National Statistics 2009).
The most common complaint is a breast lump. Other signs or
symptoms include skin abnormalities such as tethering (as if the
skinis being pulled fromthe inside), ulcerationor local discoloura-
tion (peau dorange); nipple changes which may include bleed-
ing, inversion or discharge; lumps in the axilla (underarm) or un-
commonly, breast pain. Diagnosis is made by triple assessment:
clinical examination, radiological assessment which may include
mammography or ultrasound, and histopathological assessment
of cytology or biopsy. Early breast cancer is often asymptomatic
and only detected by screening with mammography.
The current ve-year relative survival for localised breast cancer
(cancer which has not spread to lymph nodes or sites outside the
breast) is 98%. If there has been regional spread by direct invasion
toadjacent local structures or nearby lymphnodes, survival is 84%.
Distant metastatic spread is considered incurable and treatment
is directed at improving life expectancy, palliating symptoms and
improving quality of life. The most common sites of spread are
bone, lung and liver, with an overall ve-year survival rate of 23%
for metastatic breast cancer (Jemal 2009). Life expectancy in these
cases is related to the extent of metastasis, size of tumour, lymph
node involvement and whether major organs are affected.
Treatment options for breast cancer are based on tumour type,
size, stage, grade, patient genetic predisposition, patient hormone
receptor status andpatient preferences, whichmust all be evaluated
when choosing the optimum treatment i.e. curative or palliative.
Treatment with curative intent requires surgery, with or without
radiotherapy and systemic therapy. Surgery and radiotherapy both
treat cancer at a specic, local site of disease, with surgery still
the primary method for removing cancer. Surgical treatment is
directed at the breast and may also include the axilla. Although
breast-conserving surgical (BCS) procedures (lumpectomy, quad-
rantectomy and segmental mastectomy) tend to be the preferred
rst option, mastectomy may be necessary if the cancer is greater
than 4 cm, multi-focal, centrally situated or of a particular in-
vasive carcinoma subtype. BCS is the surgical removal of the tu-
mour and a rim of healthy tissue surrounding the tumour, while
mastectomy involves removal of the breast, with or without skin.
Both BCS and mastectomy may vary in the extent of surgical
resection. Subcutaneous mastectomy removes breast tissue under
the skin, while radical mastectomy can remove the entire breast
with underlying pectoralis muscle. Radical mastectomy is rarely
performed in current practice due to the extensive morbidity it
causes. Axillary surgery (removal of associated lymph glands from
under the arm) is performed by sentinel lymph node biopsy, axil-
lary lymph node biopsy or dissection of many lymph nodes. Sen-
tinel lymph node biopsy involves injecting radioisotope dye into
the breast tissue around the nipple, and removing the nodes to
which the dye spreads. These nodes are taken intra-operatively for
microscopic examination by histopathologists. If they are clear, no
further lymph nodes need to be removed. If the lymph nodes do
show signs of cancer, additional lymph nodes need to be removed.
The alternative approach is to proceed with the removal of many
lymph nodes based on the stage (spread) and grade of the cancer,
alongside imaging results and clinical examination ndings.
Treatment with radiotherapy may be given in addition to BCS
to decrease the incidence of local cancer recurrence (the cancer
returning in the same breast), and may also target the axilla in
patients with positive lymph nodes detected by sentinel biopsy
or axillary sampling. With certain subtypes of cancer (e.g. ductal
carcinoma in situ (DCIS)), radiotherapy may not be indicated.
Systemic therapy aims to treat the whole body, not just the lo-
cal site of disease, using chemotherapy, hormone treatment or
immunotherapy. Hormones such as oestrogen and progesterone
can affect the growth of certain types of breast cancer. Selectively
blocking oestrogen action or production can shrink large cancers,
decreasing the chances of local recurrence and the likelihood of
metastatic spread. There are three types of hormone therapy; ta-
moxifen,aromatase inhibitors and pituitary suppressors. Tamox-
ifen directly blocks the effect of oestrogen on tissue. Aromatase
inhibitors e.g. anastrozole, block oestrogen production from the
adrenal glands in post-menopausal women. Pituitary suppressants
e.g. goserelin, block the hormone pathways that lead to oestrogen
production. An immunotherapeutic agent, herceptin, can reduce
the chance of recurrence and disease progression in women who
carry the HER2-positive receptor. In some countries, prophylactic
bilateral mastectomies are offered to women who have inherited
BRCA gene mutations that predispose them to breast cancer.
Neoadjuvant therapy may be given before surgery in an attempt
to shrink tumours pre-operatively, and adjuvant therapy is often
givenafter surgery to reduce the chance of recurrence, and this may
include chemotherapy, hormone therapy or targeted biological
therapy.
Description of the intervention
Breast reconstruction is essential for many women to restore body
image and improve quality of life post-mastectomy. Treatment
aims to manage the psychological impact of breast cancer and in-
cludes breast reconstruction and psychological support. Recon-
structionconsists of the rebuilding of a womans breast using either
tissue from other parts of the body or implantable devices such as
silicone or saline implants. This often includes the reformation of
a natural looking areola and nipple.
A range of surgical options for reconstruction are available.
Autologous tissue procedures
Autologous reconstruction uses a patients own tissue to replace
lost breast tissue. This may be carried out as an immediate recon-
struction, in the same operation as mastectomy once it is com-
pleted. It may also be carried out as a delayed reconstructionproce-
dure, which occurs any time after the initial operation but usually
after two months to allow skin to heal. Autologous reconstruction
may be contraindicated in cases such as previous major surgery
in the required tissue, systemic medical conditions such as hyper-
tension, chronic obstructive pulmonary disease, diabetes, patients
who smoke or who have too high or too low a body mass index
(BMI).
1. Latissimus dorsi myocutaneous ap: skin and muscle aps
can be used to cover areas of excised tissue. This is achieved by
cutting a skin island and pivoting it under the axilla whilst
retaining the same blood supply. The ap can be used to cover an
implant, or on its own in small-breasted women.
2. Transverse rectus abdominus myocutaneous (TRAM) aps:
these are harvested and transferred from the abdomen to the
chest wall by joining the blood vessels of the ap (the pedicle) to
the internal mammary vessels in the chest. Blood supply to
TRAM aps is variable. Pedicled TRAM aps require the entire
rectus abdominus while microvascular TRAM aps require a
(much) smaller proportion of muscle.
3. Deep inferior epigastric perforator (DIEP) aps: these are
created from the lower abdomen without removal of muscle.
Their use is limited by anatomical constraints that cannot be
predicted pre-operatively.
4. Gluteal artery perforator (GAP) aps: these aps include
the skin and subcutaneous tissue based on the inferior and
superior gluteal vessels where the gluteal muscle is not removed.
This procedure is generally considered a second-line option.
Tissue expanders and implantable devices
Implantable devices such as silicone or saline implants can be used
immediately if there is sufcient skin or soft tissue coverage pro-
vided by a skin ap. However, if there is insufcient tissue to cover
the implant, reconstruction can be delayed while a tissue expander
is used. Tissue expanders are placed under the pectoralis muscle
and can be inated and later replaced with a denitive implant.
Ports located in the expanders allow them to be lled with saline
in the post-operative period. Expansion causes gradual stretching
and growth of the soft tissue such that the excess skin can then be
used at that site to cover an implant.
How the intervention might work
The timing and decision of when to carry out breast reconstruc-
tion remains controversial and will often depend on individual
circumstances, in addition to whether adjunctive radiotherapy is
required. In planning reconstruction it is important that the pri-
mary focus should be effective cancer treatment, around which
the aesthetic goals of reconstruction must be tailored.
Immediate reconstruction
This is performed at the time of the mastectomy and is indicated
primarily for patients who are unlikely to require additional ra-
diotherapy. Predicting whether radiotherapy will be required after
surgery is not always feasible and in borderline cases may result in
a surgeon advocating delayed reconstruction.
A number of studies have shown that reconstruction is onco-
logically safe directly after mastectomy even in advanced disease,
thereby making this procedure even more acceptable for patients
(Giacalone 2010; Langstein 2003; Newman 1999). It is claimed
that early reconstruction tends to lead to better aesthetic outcomes
(McCarthy 2005) since the breast envelope is preserved together
with the inframammary fold and offers a better prospect of recre-
ating a natural shape, with more symmetry to the breast. Adding
a myocutaneous ap (well-vascularised and non-radiated) at the
time of mastectomy can also be advantageous as it can promote
tissue healing (Bostwick 1990).
Immediate reconstructionfollowing breast cancer surgery is recog-
nised to be an important consideration in the reduction of anx-
iety levels as well as in improving self-esteem and quality of life
(Drucker-Zertuche 2007). One study reported that 95% of the
patients who had received immediate reconstruction were content
with the outcome as compared with 76%of those who underwent
delayed reconstruction and who also indicated that they would
have preferred immediate reconstruction (Al-Ghazal 2000).
Controversy remains over the possible detrimental effects of adju-
vant radiotherapy on immediate breast reconstruction. A number
of studies have shown that radiation after immediate reconstruc-
tion gives poor results and compromises aesthetic results. When
breasts that have been reconstructed with implants are subjected
to radiotherapy, complications may arise and these can include
impaired skin healing, brosis, implant extrusion and capsular
contractures (Behranwala 2006, Forman 1998; Kronowitz 2009;
Tallet 2003; Whiteld 2009). Complications can also occur when
autologous aps undergo radiotherapy. Early complications in-
clude thrombosis, ap necrosis or loss, and local wound-healing
problems, while late complications included hyperpigmentation,
fat necrosis, volume loss, and ap contracture (Kronowitz 2009;
Kronowitz 2004; Rogers 2002; Spear 2005; Thomson 2008; Tran
2001). Tissue expansion is often poorly tolerated by many pa-
tients (Tallet 2003) and can lead to complications such as a con-
cave deformity of the chest wall (Fodor 1989). Several studies have
reported contradictory results which suggest that careful choice
of immediate reconstruction technique or adjuvant therapy can
minimise some of the adverse events that can occur after adjuvant
therapy (Hussien 2004; von Smitten 1992; Williams 1995).
Delayed reconstruction
Delayed reconstruction is indicated when post-mastectomy radio-
therapy is required, or likely to be required. A further indication
would be when patients are not ready or willing to engage in plan-
ning a reconstructive procedure until more time has passed since
their diagnosis. The delayed approach is also used in partial breast
mastectomy, when the margins of resection are not known at the
time of the operation and further excision may be required. De-
layed reconstruction can be technically challenging because radi-
ation can lead to tissue brosis in the chest wall tissue.
Implants may be placed at the time of mastectomy, as part of a
delayed procedure, before irradiation, after which autologous aps
are created. However, this may also result in sub-optimal outcomes
with worse cosmetic results, more painful expansion and greater
risk of revision surgery (Cordeiro 2004; Krueger 2001).
Patients who select the delayed approach have more time to con-
sider the various surgical options. A patient has to cope with the
burden of the diagnosis and the ongoing psychological pressures
of dealing with the physical and social consequences of the disease.
Delayed reconstruction gives her the time to seek advice fromplas-
tic and breast surgeons, thereby allowing more time for evaluation
of the various reconstructive techniques available once denitive
cancer treatment has been completed. In patients who have un-
dergone radiation therapy, it also permits clinical assessment of the
irradiated tissue and complications of radiotherapy such as non-
viable tissues which can be removed during reconstruction.
The disadvantages of a delayed approach are largely psychological,
due to the burden of patients living with breast deformity until
reconstruction is completed. Some studies have reported this as
leading to lower self-esteem and body image, causing depression
and anxiety (Fernandez-Delgado 2008). There are also technical
difculties with a delayed approach, beyond the difculties of deal-
ing with irradiated tissue. Larger aps are required because of the
need for skin replacement, symmetry is difcult to achieve, and
contralateral mastopexy (lifting breast tissue and removing skin)
may be required in many cases. However, some studies have shown
that delayed procedures have had excellent long-term aesthetic re-
sults (Schuster 1992). Patients are oftencounselled to have realistic
expectations for the aesthetic outcome of delayed reconstruction,
especially if the eld was previously irradiated. Patient evaluation
of aesthetic outcomes can vary depending on the time reconstruc-
tion takes place.
Why it is important to do this review
Outcomes such as morbidity, cosmetic outcomes and psycholog-
ical benets may differ between immediate or delayed breast re-
construction post-mastectomy. A summary of the evidence for the
benets, both clinical and psychological, could help facilitate bet-
ter shared decision-making between clinicians and patients on the
best treatment.
O B J E C T I V E S
To assess the effects of immediate versus delayed reconstruction
following surgery for breast cancer.
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised controlled clinical trials (RCTs).
Types of participants
Women in any age group with any stage of breast cancer in either
of the following two treatment groups.
1. Delayed breast reconstruction to one or both breasts post-
mastectomy.
2. Immediate reconstruction to one or both breasts concurrent
with mastectomy.
The only included trial evaluated both treatments.
Types of interventions
We compared immediate reconstruction versus delayed recon-
struction. We considered any appropriate and recognised meth-
ods of reconstruction. We included studies in which immediate
reconstruction was compared with the option of delayed or no
treatment. See Differences between protocol and review
Types of outcome measures
Primary outcomes
1. Post-operative morbidity (number of surgical
complications) and mortality.
Secondary outcomes
1. Patient cosmetic or functional satisfaction with
reconstruction, assessed using any validated generic or disease-
specic questionnaire.
2. Psychosocial well-being post-reconstruction, assessed using
any validated generic or disease-specic scale.
Search methods for identication of studies
See: Breast Cancer Group methods used in reviews.
Electronic searches
For the identication of studies we searched the following
databases.
(1) Cochrane Breast Cancer Group Specialised Register
Details of search strategies used by the Group for the identication
of studies and the procedure used to code references are outlined
in the groups module (Cochrane Breast Cancer Group 2009). We
extracted trials coded with the key words surgery, carcinoma in
situ, early breast cancer, locally advanced breast cancer and ad-
vanced breast cancer for consideration. We conducted the search
on 22 July 2010.
(2) MEDLINE (via OVID) from July 2008 onwards
We ran the subject search with the Cochrane Highly Sensitive
SearchStrategy (CHSS) for identifying randomisedtrials inMED-
LINE: sensitivity-maximising version (2008 revision) as refer-
encedinChapter 6.4.11.1anddetailedinbox 6.4.c of the Cochrane
Handbook for Systematic Reviews of Interventions Version 5.0.0 (up-
dated February 2008) (Higgins 2008). See Appendix 1 for the full
search strategy conducted on 26 August 2010.
(3) EMBASE (via OVID) from 2008 onwards
We conducted the search on the EMBASE database (i.e. from
2008) on 26 August 2010. See Appendix 2 for the full search
strategy.
Searching other resources
1. We searched bibliographical references of identied studies
for references to additional studies.
2. We searched clinical trials registries: the WHO
International Clinical Trials Registry Platform (ICTRP) search
portal http://apps.who.int/trialsearch/ on 26 August 2010. See
Appendix 3.
Although we did not impose language restrictions on included
studies, we did not identify any relevant reports in languages other
than English. We contacted the publisher of an earlier review (
Anthony 1995), that evaluated the effects of immediate versus
delayed reconstruction but we were unsuccessful in obtaining a
copy of the report.
Data collection and analysis
Selection of studies
Two review authors (Nigel DSouza (ND) and Zbys Fedorowicz
(ZF)) independently assessedthe abstracts of studies resulting from
the searches. We obtained full copies of all relevant and potentially
relevant studies, those appearing to meet the inclusion criteria, and
those for which there were insufcient data in the title and abstract
to make a clear decision. The two review authors independently
assessed the full-text papers and resolved any disagreement on the
eligibility of included studies through discussion and consensus
with the third author (Geraldine Darmanin (GD)). We excluded
all irrelevant records andnoteddetails of the studies andthe reasons
for their exclusion in the Characteristics of excluded studies table
in RevMan 5 (RevMan 2008).
Data extraction and management
We entered study details into the Characteristics of included
studies table in RevMan 5. We collected outcomes data using a
pre-determined formdesigned for this purpose and we entered the
data into Table 1. We only included data if we reached consensus
or resolved any disagreements by consulting with a third review
author (GD).
We extracted the following details.
1. Trial methods: (a) method of allocation; (b) masking of
participants, trialists and outcomes assessors; (c) exclusion of
participants after randomisation and proportion and reasons for
losses at follow-up.
2. Participants: (a) country of origin and location: private
clinic or academic institute; (b) sample size; (c) age; (d) sex; (e)
inclusion and exclusion criteria.
3. Intervention: (a) type; (b) length of time in follow-up.
4. Control: (a) type; (b) length of time in follow-up.
5. Outcomes: (a) primary and secondary outcomes mentioned
in the Types of outcome measures section of this review.
If stated, we planned to record the sources of funding.
The review authors intended to use this information to help them
assess heterogeneity and the external validity of the trials.
Assessment of risk of bias in included studies
Each reviewauthor assessed and graded the selected trial following
the domain-based evaluation described in the Cochrane Handbook
for Systematic Reviews of Interventions 5.0.0 (Higgins 2008). We
compared these evaluations and we resolved any inconsistencies
and disagreements by discussion.
We assessed the following domains as Yes (i.e. low risk of bias),
Unclear (i.e. uncertain risk of bias) or No (i.e. high risk of bias):
sequence generation;
allocation concealment;
blinding (of participants, personnel and outcome assessors);
incomplete outcome data; and
selective outcome reporting.
We reported these assessments in the Risk of bias table in the
Characteristics of included studies section of the review.
Measures of treatment effect
The outcomes we specied for this reviewwere mortality, morbid-
ity, quality of life and included measures of self-esteemand patient
satisfaction with the procedures. We intended to assess continu-
ous data using standardised mean differences (SMD), and binary
outcomes using odds ratios (OR). We planned to divide outcome
variables reported at different time points into immediate, short
and long term follow-up.
Unit of analysis issues
We expectedthat eligible trials may have involvedparticipants with
bilateral breast reconstruction and therefore the unit of analysis
would have been at the level of randomisation of either the breast
or the individual, whichever was appropriate.
Dealing with missing data
In view of the age of the included study, we did not attempt to
retrieve missing data from the investigators. Missing data were
largely attributable to withdrawals/protocol deviations and thus
we have only provided a descriptive summary of the results as
reported.
Assessment of heterogeneity
We only included one trial in this review, therefore, it was not
feasible to assess heterogeneity but in future updates and if further
trials are identied we will apply the following methods.
We will assess clinical heterogeneity by examining the characteris-
tics of the studies, the similarity between the types of participants,
the interventions and the outcomes, as specied in the criteria for
included studies. In view of the expectation of a degree of clinical
heterogeneity between the studies we intend to use the random-
effects model with studies grouped by action.
We will assess statistical heterogeneity using the I
2
statistic
(Higgins 2003).
We will evaluate the I
2
statistic as follows:
0% to 40%: might not be important;
30% to 60%: may represent moderate heterogeneity;
50% to 90%: may represent substantial heterogeneity;
75% to 100%: considerable heterogeneity.
Assessment of reporting biases
If further eligible studies are identied, we will follow the recom-
mendations on testing for funnel plot asymmetry as described in
section 10.4.3.1 of the Cochrane Handbook for Systematic Reviews
of Interventions 5.0.0 (Higgins 2008). Funnel plot asymmetry may
be due to reporting bias, and we will address this possibility in the
Discussion if appropriate. We recognise that these results need
to be interpreted cautiously if analysing small study effects with
dichotomous outcomes.
Data synthesis
If adequate data are available in future updates, we will use the
following methods of data synthesis.
Two review authors (ZF and ND) will analyse the extracted data
and report them as specied in Chapter 9 of the Cochrane Hand-
book for Systematic Reviews of Interventions Version 5.0.0 (Higgins
2008). Please see Unit of analysis issues.
The outcomes speciedfor this reviewinclude morbidity andqual-
ity of life, therefore, we will make decisions regarding if and how
to combine separate outcomes data depending on if and how this
information is collected in each trial. The data are most likely to
be assessed as ordinal outcome data. However, our decisions for
analysis will be guided explicitly by, and based on,the recommen-
dations for dealing with effect measures for ordinal outcomes and
measurement scales in section 9.2.4 of the Cochrane Handbook for
Systematic Reviews of Interventions Version 5.0.0 (Higgins 2008).
We will report data and if feasible, we will synthesise the data ac-
cording to this guidance.
We will use the random-effects model for the synthesis and meta-
analysis of any quantitative data.
Inthe event that there are insufcient clinically homogeneous trials
for any specic intervention or insufcient study data that can be
pooled, we will present a narrative synthesis.
Subgroup analysis and investigation of heterogeneity
Lack of included studies did not permit a subgroup analysis, but
if data are subsequently available for a sufciently large number of
participants, we will undertake subgroup analyses in which par-
ticipants are categorised by age, staging of breast cancer at time of
diagnosis, and the type of reconstruction performed.
Sensitivity analysis
We did not carry out a sensitivity analysis but if future updates in-
clude a sufcient number of studies, we plan to conduct sensitivity
analyses to assess the robustness of our review results by repeating
the analysis with the following adjustments: exclusion of studies
with unclear or inadequate allocation concealment, blinding of
outcomes assessment and completeness of follow-up.
R E S U L T S
Description of studies
See: Characteristics of includedstudies; Characteristics of excluded
studies.
See: Characteristics of included studies and Characteristics of
excluded studies.
Results of the search
Fromthe electronic searches, including the recent updates (August
2010), we retrieved 411 references to studies. After examination of
the titles andabstracts of these references, we eliminatedall of those
which did not match our inclusion criteria and those which were
clearly ineligible from the review. We obtained full text copies of
the remaining nine potentially eligible trials for further evaluation.
The review authors discussed the eligibility of these trials and
resolved any remaining uncertainties by consensus. Subsequently
only one study proved to be eligible for inclusion in this review
and therefore, we excluded the remaining eight studies.
Included studies
We included only one study in this review (Dean 1983).
Characteristics of the trial setting and investigators
This RCT was conducted at the Longmore Hospital, Edinburgh
between October 1978 and July 1980. The providers of care were
hospital staff in the breast surgery unit and the outcomes assessors
were the surgeons, psychiatrists, psychologists and nurse counsel-
lors.
Characteristics of the participants
The participants were 64womenbelowthe age of 60, and although
the report indicated that there was no signicant difference in age,
marital status, TNM (tumour, node, metastasis) staging or treat-
ment options (radiotherapy, chemotherapy and oophorectomy),
the investigators provided very limited demographic information.
Characteristics of the interventions
All of the participants underwent total mastectomy which in-
cluded axillary node clearance for some participants. This was fol-
lowed by immediate reconstruction for 33 participants or the op-
tion of delayed reconstruction at 12 months post-mastectomy for
31 participants. A sialastic subpectoral prosthesis (Heyer-Schultz)
was provided for 33 participants at the time of mastectomy. The
31 participants in the delayed reconstruction group were advised
about an external prosthesis and although all patients were offered
delayed reconstruction, only six took up the option 12 months
after mastectomy.
Post-operative care consisted of penicillin V (1 gm/day) and u-
cloxacillin (1 gm/day) orally for ve days. Patients with positive
nodes received either radiotherapy, or chemotherapy/oophorec-
tomy.
Characteristics of the outcome measures
Assessments were made at three and 12 months post-operatively,
which included morbidity across different domains (psychiatric,
sexual, social, marital and work) using Spitzers Research Diagnos-
tic Criteria for major depression or Feighner Criteria for depres-
sion or anxiety. A self-rated general health questionnaire was used
as a screening instrument for psychiatric morbidity.
Cosmetic assessment of the implant group was carried out at
nought to 17 months post-operatively by a panel of two surgeons,
a psychiatrist, a psychologist and a nurse counsellor. A non val-
idated tool was used to evaluate cosmetic outcomes, which in-
cluded assessments of the symmetry of the breast both with and
without a bra, rated on a three-point scale of 5 = good, 3 = average,
1 = poor. Patient assessment of cosmetic results using a scale rated
as ugly/not ugly/almost normal were also undertaken 3 and 12
months post-operatively (Table 1).
Excluded studies
All of the studies which were excluded from this review and the
reasons for their exclusion are reported in the Characteristics of
excluded studies table.
Risk of bias in included studies
We assessed the single included study as having a high risk of bias
(plausible bias that seriously weakens condence in the results)
because one or more of the criteria were not met. Further details
of the assessments of these criteria are available in the Risk of
bias table in the Characteristics of included studies and are also
presented in the Risk of bias graph in Figure 1 and the Risk of
bias summary in Figure 2.
Figure 1. Risk of bias graph: review authors judgements about each risk of bias item presented as
percentages across all included studies.
Figure 2. Risk of bias summary: review authors judgements about each risk of bias item for each included
study.
We based these assessments on the inadequate reporting of the
criteria that are a prerequisite in the evaluation of methodological
rigour in terms of trial design and conduct. Although conceal-
ment of the allocation sequence and blinding are considered to
be key domains in the assessment of risk of bias, the investigators
provided insufcient detail to enable accurate judgements to be
made. Protocol deviation and losses to follow-up with incomplete
outcome data were other important sources of potential bias in
the included study (see Risk of bias table in Characteristics of
included studies).
Allocation
The methods used to generate the allocationsequence and howthe
sequence was concealed, such that participants and investigators
enrolling participants could not foresee the upcoming assignment,
are the most important and sensitive indicators that bias has been
minimised in a clinical trial. Randomisation and allocation was
reported to have been carried out in the operating room post-
mastectomy but no further details were provided and therefore we
considered the judgement for this domain to be unclear.
Blinding
Blinding of the participants and caregivers was not feasible in this
study because of the nature of the actual interventions offered
and received. However, it should have been possible to at least
ensure blinding of outcomes assessments by excluding the care
givers and anyone directly involved with the conduct of the trial
from evaluating the outcomes.
Incomplete outcome data
Incomplete outcome data presented the highest risk of bias in this
study. Although the trial compared immediate with delayed breast
reconstruction, only six out of 31 women took up the option of
delayed reconstruction and no follow-up data were reported for
these participants or those who chose not to have the reconstruc-
tion.
Two participants in the implant group were not seen for pre-
operative psychiatric assessments, a further four participants either
refused to return or could not be traced and 14 out of 64 of the
health questionnaires were not returned. The report did not clearly
and comprehensively report the number of losses pertaining to
each of the intervention groups or the reasons for these losses of
outcome data.
The reporting of outcome data was not clear and in most instances
it was not possible to disentangle the outcome data separately for
each of the intervention groups.
Selective reporting
The reporting of outcomes in this older study although not ideal
was somewhat consistent with the editorial style and standards
existing at the time of its publication.
Although the protocol was not available for the included study,
based on the information in the methods section of the report, the
investigators appear to have reported some data on most of their
prespecied outcomes and therefore, we judged the study to be
relatively free of selective reporting.
Other potential sources of bias
A total of 125 women were invited to enter the study out of
which only 64 were enrolled and its possible that this may have
introduced an element of sampling bias into the study.
Effects of interventions
We could not present data on the effects of these interventions
graphically in RevMan, and therefore some of these have been
reported together with relevant comments inthe Data and analyses
section of the review and in Table 2.
We categorised the one RCT included in this review as high risk
of bias and therefore caution is advised in interpreting the results
and extrapolating the effects of interventions.
D I S C U S S I O N
Summary of main results
We only included one RCT in this review. It was disappointing
to see the paucity of prospective RCTs comparing these interven-
tions and that our primary outcome of post-operative morbidity
(number of surgical complications) and mortality had not been as-
sessed in the single included study. Only our secondary outcomes
of cosmetic satisfaction and psychosocial well-being had been ad-
dressed but these data were incomplete due to protocol deviation
by a substantial number of participants in the delayed treatment
arm. Based on data collected from psychiatric interviews of the
participants and self-rated health questionnaires there was some,
albeit limited and unreliable, evidence that immediate reconstruc-
tion compared with delayed or no reconstruction reduced psychi-
atric morbidity expressed as the case rate at three months post-
operatively.
Overall completeness and applicability of
evidence
The included RCT was conducted over 25 years ago, limiting its
applicability to current surgical practice. Although sialastic im-
plants are still used in reconstruction, autologous aps tend to pro-
vide improved cosmetic outcomes and are more commonly used
in most specialist centres. The review also failed to identify any
RCTs evaluating the evidence for the effectiveness of other types
of implants and some of the other surgical procedures.
Quality of the evidence
Although we considered the included RCT to be of sub-optimal
quality and assessed it as being at high risk of bias, we have reported
its results as it was the only prospective RCT that matched our
inclusion criteria. We are unaware of any unpublished studies, and
currently there are no ongoing RCTs listed on the WHO ICTRP
search portal.
Limitations in study design
The overall clinical design of the included study was inadequate
and we have reported the limitations of its methodological quality
in our assessment of the risk of bias and include the following.
1. Inadequate reporting of the methods used to generate the
sequence, to conceal the allocation in addition to a lack of
adequate measures to blind outcomes assessors. The lack of
available additional or incomplete trial information and data
prevented an accurate assessment of the risk of bias.
2. Outcome data were either incomplete or not clearly
reported which meant that we could not enter data into a
RevMan analysis.
Directness of evidence
Participants in the control group in the included study were given
the option to forego reconstruction at a later date. Twenty-ve of
the 31 participants did not proceed to reconstruction, resulting
in the trial failing to provide a reliable direct comparison of the
benets of immediate versus delayed reconstruction.
Moreover, in view of the low take-up of delayed reconstruction
any direct comparisons of, for example, the cosmetic effects of
immediate versus no reconstruction, cannot be considered a fair
comparison and would thus limit the generalisability of any evi-
dence. This holds equally true for the comparisons of complica-
tions of surgery with immediate versus no reconstruction, because
it would not be possible to include assessments of complications
after delayed reconstructive surgery.
Patient-preferred primary outcomes are a pre-requisite for inform-
ing evidence-based clinical decision-making and thus the absence
of data from RCTs on certain patient-important outcomes i.e. as-
sessments of post-operative morbidity (number of surgical com-
plications) and mortality justies further downgrading of the level
of evidence.
Inconsistency of results
As only one RCT was included in this review, this assessment was
not applicable.
Imprecision of results
The limited amount of outcome data available from this single
trial did not permit any assessment of the precision of the results.
Probability of publication bias
We could not estimate publication bias as only one trial was in-
cluded in this review.
Potential biases in the review process
We did not identify any sources of potential bias in the review
process.
Agreements and disagreements with other
studies or reviews
This reviewshares some of the conclusions reached by other cohort
studies and reviews (Atisha 2009; Fischbacher 2002; Harcourt
2001) which have focused on this research question. All of these
have emphasised the considerable heterogeneity in participants in
individual studies and between studies. They also found a paucity
of methodologically rigorous research exploring clinical and psy-
chosocial outcomes following immediate or delayed breast recon-
struction. The majority of studies conducted have been retrospec-
tive analyses. Prospective studies that have been conducted lack
comparison or control groups, and have reported outcomes that
have been evaluated using different questionnaires or assessment
tools, and therefore do not permit fair comparisons or synthesis
of data. Much of this evidence from prospective trials is based on
cohort studies (Al-Ghazal 2000; Alderman 2002; DeBono 2002;
Francel 1993; Mandrekas 1995).
One systematic review (Fischbacher 2002) included a series of co-
hort studies in addition to a single RCT (Dean 1983) which, in
contrast to our assessment, the authors considered to be of mod-
erate quality. The conclusions reached in a more recent system-
atic review (Guyomard 2007) pointed to the very limited number
of studies evaluating important patient reported outcomes (PRO)
of patient satisfaction. The review authors also reported multiple
aws in methodology of the few included trials which made their
analysis difcult and limited the validity and subsequent general-
isability of any of their results. However, in agreement with our
review, the authors stated that further research is required and that
future trials should be robust in quality to ensure reliable assess-
ment of relevant patient-preferred outcomes.
The summary in a literature review (Harcourt 2001) indicated
that there was still uncertainty about which treatment confers the
greatest psychological benet and that further research needs to
consist of studies with a multi-centred prospective design com-
bining both qualitative and quantitative components. In contrast
with most of these reviews the investigators in a prospective cohort
study reported psychosocial benets and body image gains which
persisted at two years following immediate reconstruction (Atisha
2009). Although we were unable to obtain copies of an earlier
review (Anthony 1995) which evaluated the effects of immediate
versus delayed reconstruction, this review had been assessed by
Fischbacher 2002 who reported a number of methodological lim-
itations including the lack of a systematic assessment of the quality
and relevance of studies.
A U T H O R S C O N C L U S I O N S
Implications for practice
We included only one RCT that, which did not consider our pri-
mary outcome of post-operative surgical complications and only
partially addressed our pre-specied secondary outcomes of psy-
chosocial well-being post-reconstruction in this review. The nd-
ing that immediate reconstruction reduced psychiatric morbidity
at three months should only be accepted while acknowledging
the methodological shortcomings and high risk of bias inherent
in the trial. The application of these ndings is further limited
given that the surgical technique for immediate reconstruction in
this 27-year old trial is not current recommended practice. Un-
fortunately, the very limited number of study participants in the
control (delayed intervention) group in the included study who
later decided to undergo reconstruction were not analysed and
the results of this subgroup might have shed light on important
psychological or cosmetic outcomes. The included trial provides
very limited evidence which is likely to inform decision-making
in clinical practice.
Implications for research
The paucity of relevant trials, illustrated by a single study carried
out over 25 years ago, points to the need for further research in this
eld. One of the main barriers to further research would appear
to be that the benets of post-operative radiotherapy to the breast
are well known with regards to recurrence (Whelan 2000), if not
on overall mortality (Early Breast Cancer Trialists Collaborative
Group). Immediate reconstruction may not be carried out if ra-
diotherapy is planned, with its recognised and potentially adverse
aesthetic outcomes.
Constraints in terms of study design, and in particular RCTs, has
meant that much of the previous research consists of cohort stud-
ies, audits and surveys rather than large-scale trials. The inade-
quate methodological quality of many of these was highlighted in
Guyomard 2007, and in spite of this, there is well-documented
resistance to RCTs in the evaluation of psychological outcomes
for these interventions (Atisha 2009; Harcourt 2001). The ethical
obstacles to randomised trials have been attributed to the removal
of womens input into decision-making (Harcourt 2001). This re-
port found that in Dean 1983, a lack of participant control over
the timing or type of reconstruction raises serious ethical concerns,
since involvement in decision-making may be a crucial factor in
improving psychological outcomes.
However, given that RCTs have been and are still being conducted
in surgical domains where shared clinical decision-making is still
the norm, and have yielded valuable information, the question is
why this should not be possible in breast reconstruction. Since
RCTs remain the most reliable study design to remove confound-
ing and sources of bias, modications such as the Zelens design
with double randomised consent may have implications for future
research.
Future randomised controlled trials must be well designed, con-
ducted and adequately delivered with subsequent reporting, in-
cluding high quality descriptions of all aspects of methodology.
Rigorous reporting needs to conform to the Consolidated Stan-
dards of Reporting Trials (CONSORT) statement (www.consort-
statement.org/) and this will enable appraisal and interpretation of
results, and accurate judgements to be made about the risk of bias
and the overall quality of the evidence. Although it is uncertain
whether reported quality mirrors actual study conduct, it is note-
worthy that studies with unclear methodology have been shown to
produce biased estimates of treatment effects (Schulz 1995). Ad-
herence to guidelines, such as the CONSORT statement, would
help ensure complete reporting.
For further research recommendations based on the EPICOT for-
mat (Brown 2006) please see (Table 2).
A C K N O W L E D G E M E N T S
The authors would like to acknowledge the support they have
received from the Cochrane Breast Cancer Group in conducting
this review.
R E F E R E N C E S
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of Surgical Oncology 2008;15(4):108191. [PUBMED:
18224376]
Tran 2001
Tran NV, Chang DW, Gupta A, Kroll SS, Robb GL.
Comparison of immediate and delayed free TRAM ap
breast reconstruction in patients receiving postmastectomy
radiation therapy. Plastic and Reconstructive Surgery 2001;
108(1):7882.
von Smitten 1992
von Smitten K, Sundell B. The impact of adjuvant
radiotherapy and cytotoxic chemotherapy on the outcome
of immediate breast reconstruction by tissue expansion after
mastectomy for breast cancer. European Journal of Surgical
Oncology 1992;18(2):11923. [PUBMED: 1582504]
Whelan 2000
Whelan TJ, Julian J, Wright J, Jadad AR, Levine ML. Does
locoregional radiation therapy improve survival in breast
cancer? A meta-analysis. Journal of Clinical Oncology 2000;
18(6):12209. [PUBMED: 10715291]
Whiteld 2009
Whiteld GA, Horan G, Irwin MS, Malata CM, Wishart
GC, Wilson CB. Incidence of severe capsular contracture
following implant-based immediate breast reconstruction
with or without postoperative chest wall radiotherapy using
40 Gray in 15 fractions. Radiotherapy and Oncology 2009;
90(1):1417. [PUBMED: 18977547]
Williams 1995
Williams JK, Bostwick J, Bried JT, Mackay G, Landry J,
Benton J. TRAM ap breast reconstruction after radiation
treatment. Annals of Surgery 1995; Vol. 221, issue 6:756-
64.
Indicates the major publication for the study

C H A R A C T E R I S T I C S O F S T U D I E S
Characteristics of included studies [ordered by study ID]
Dean 1983
Methods Randomised controlled trial in Longmore Hospital Edinburgh between October 1978
and July 1980
Participants N = 64 women, age unspecied but all under 60 years.
INCLUSION CRITERIA:
primary operable breast cancer (T
12
N
01
) requiring mastectomy;
no metastatic disease (normal pelvis/chest x rays, bone and liver isotope scans and
liver function tests).
EXCLUSION CRITERIA:
over 60 years;
non-operable breast cancer;
metastatic disease.
WITHDRAWALS/LOSSES TO FOLLOW-UP:
Immediate Group: 2 withdrawals after randomisation (1) not reconstructed for technical
reasons feasible, (1) had implant accidentally aspirated post-operatively
Delayed Group: withdrawals (25) i.e. chose no reconstruction.
Interventions Total mastectomy (with axillary node clearance for some participants), followed by im-
mediate reconstruction compared with an option of delayedreconstruction at 12 months
INTERVENTION:
(31/33) sialastic subpectoral prosthesis (Heyer-Schultz).
Post -op care: penicillin V (1 gm/day) and ucloxacillin (1 gm/day) orally for 5 days.
Participants with positive nodes received radiotherapy, node-positive and premenopausal
received chemotherapy or oophorectomy
CONTROL:
(6/31) opted for delayed reconstruction.
Outcomes PRIMARY OUTCOMES:
No post-operative morbidity or mortality was reported.
SECONDARY OUTCOMES:
cosmetic appearance assessed at 9 to 17 months by investigators and panel of
assessors (3-point scale: 5 = good, 3 = average, 1 = poor);
psychological assessments by interview at 3 and 12 months, psychiatric, sexual,
social, marital, and work morbidity;
participants completed a general health questionnaire.
ADVERSEEVENTS: No reporting of long termpost-op complications or adverse events
Notes The comparisons were mastectomy with immediate reconstruction versus mastectomy
and optional delayed reconstruction.
Unclear if the evaluations included the 6/31 in the delayed reconstruction (12 months
post mastectomy) group
Risk of bias
Dean 1983 (Continued)
Bias Authors judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk Quote: were randomly allocated The
patient was then randomised in the oper-
ating room to either receive an implant or
not. were randomly selected.... Pg 459.
Comment: Insufcient information in the
report about the method use to generate
the allocation sequence
Allocation concealment (selection bias) Unclear risk The method used to conceal the allocation
sequence, that is to determine whether in-
terventionallocations couldhave beenfore-
seen in advance of, or during enrolment,
was not reported.
Comment: Insufcient informationto per-
mit judgement Yes or No
Blinding (performance bias and detection
bias)
All outcomes
High risk Participants: not possible to blind.
Healthcare providers: not possible to blind.
Outcomes assessors and data analysts: un-
clear who were the outcomes assessors, but
at least some were investigators. Unclear if
the data analysts were blinded
Incomplete outcome data (attrition bias)
All outcomes
High risk 2 participants (implant group) were not
seen for pre-operative psychiatric assess-
ments.
No post -operative data for the delayed re-
constructiongroup(6/31), andmissing fol-
low-up data for 4 participants in the im-
mediate reconstruction group.
Cosmetic appearance of patients with im-
plants assessments at 9 to 17 months, un-
clear whether this data includedthe delayed
implant group (6).
General HealthQuestionnaire: Incomplete
data 14/64 (22%) at followup, but unclear
from which group and the reasons.
Data analysis did not conformto ITTprin-
ciples.
Selective reporting (reporting bias) Low risk The stated objectives of the study appeared
to match the reported outcomes
Other bias High risk Possible sampling bias at enrolment. Ran-
domisation to reconstruction or no recon-
struction occurred after the mastectomy
Dean 1983 (Continued)
procedure, the possibility of selection bias
cannot be ruled out
ITT: intention-to-treat
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Alderman 2002 Non RCT, prospective cohort.
Atisha 2009 Non RCT, retrospective.
Cheng 2006 Non RCT.
Fernandez-Delgado 2008 Non RCT, questionnaire.
Harcourt 2003 Non RCT.
Neyt 2005 Non RCT.
Roth 2007 Non RCT.
Wilkins 2000 Non RCT, prospective cohort study.
RCT: randomised controlled trial
D A T A A N D A N A L Y S E S
Comparison 1. Immediate versus delayed reconstruction
Outcome or subgroup title
No. of
studies
No. of
participants
Statistical method Effect size
1 Data that cannot be presented
graphically in Revman
Other data No numeric data
Analysis 1.1. Comparison 1 Immediate versus delayed reconstruction, Outcome 1 Data that cannot be
presented graphically in Revman.
Data that cannot be presented graphically in Revman
Study Participants Interventions Outcomes Notes
Dean 1983 64 women, <60yrs,
Primary operable breast
cancer (T
1,2
N
0,1
)
Total mastectomy and im-
mediate reconstruction ver-
sus the option of delayed re-
construction (12 months)
INTERVENTION:
(33) Sialastic
prosthesis.
CONTROL:
(31) offered delayed
reconstruction, 6 accepted.
WITHDRAWALS DUE
TO PROTOCOL DEVIA-
TION:
(25) delayed
reconstruction group
PRIMARY OUTCOMES:
Not addressed.
SECONDARY
OUTCOMES:
Participant assessed
cosmetic evaluations (Ugly/
not ugly/almost normal) at
3 and 12 months of those
who received immediate
implants and control.
See Table 1. No data re-
ported for (6) participants
with delayed reconstruction
Cosmetic appearance
(investigator assessed).
Psychological
assessments by interview at
3 and 12 months,
psychiatric, sexual, social,
marital, and work
morbidity.
General health
questionnaire (participant
assessed)
AD-
VERSE EVENTS: No post
operative adverse events re-
ported.
Our primary outcome was
not addressed, secondary
outcomes of patient cos-
metic evaluations and psy-
chosocial well-being post-
reconstruction were inade-
quately reported
A D D I T I O N A L T A B L E S
Table 1. Participants cosmetic evaluations at 3 and 12 months
Assessment 3 months 12 months
Implant No implant Implant No Implant
Ugly 11 20 8 17
Not ugly 11 8 21 11
Almost Normal 8 2 2 1
Total 30 30 31 29
64 randomised: 31 immediate reconstruction, 6/33 delayed reconstruction (Data inconsistently unreported)
Table 2. Research recommendations based on a gap in the evidence of immediate versus delayed reconstruction following
surgery for breast cancer
Core elements Issues to consider Status of research for this review
Evidence
(E)
What is the current state of evidence? Asystematic reviewfound very limited reliable evidence
for the benets or harms of immediate compared with
delayed reconstruction following surgery for breast can-
cer
Population
(P)
Diagnosis, disease stage, comorbidity, risk factor, sex,
age, ethnic group, specic inclusion or exclusion crite-
ria, clinical setting
Any age group with a diagnosis of primary operable
breast cancer requiring mastectomy, without evidence
of metastatic disease (normal pelvis/chest x-rays, bone
and liver isotope scans and liver function tests)
Exclusion criteria:
non-operable breast cancer,
metastatic disease.
To limit geographical and cultural biases and ensure a
wider generalisability of the evidence, greater empha-
sis should be placed on a more culturally diverse pop-
ulation and which may include multi-centred interna-
tional settings for future studies
Intervention
(I)
Type, frequency, dose, duration, prognostic
factor
Total mastectomy (with/without axillary node clear-
ance), followed by immediate reconstruction with an
autologous ap and/or any other form of implant
Comparison
(C)
Type, frequency, dose, duration, prognostic
factor
Delayed reconstruction at 12 months.
Outcome
(O)
Which clinical or patient related outcomes will the re-
searcher need to measure, improve, inuence or accom-
Clinical outcomes:
mortality,
Table 2. Research recommendations based on a gap in the evidence of immediate versus delayed reconstruction following
surgery for breast cancer (Continued)
plish?
Which methods of measurement should be used?
intra and post operative complications/adverse
events.
Patient-preferred outcomes:
quality of life, emotional and psychological
morbidity, cosmetic appearance (assessed with
validated generic or disease-specic assessment tools).
Time Stamp
(T)
Date of literature search or recommendation EMBASE and Medline till 26th August 2010, ICTRP
and Cochrane Breast Cancer Groups Specialised Reg-
ister till 22nd July 2010
Study Type What is the most appropriate study design to address
the proposed question?
Randomised controlled trial (adequately powered) with
up to a 5 year follow-up
Methods: concealment of allocation sequence
Blinding: Not possible to blind participants or care
givers but outcomes assessors and data analysts should
be blinded
Setting: Specialised surgical/ plastic surgery unit.
A P P E N D I C E S
Appendix 1. MEDLINE search strategy (via Ovid)
1. randomised controlled trial.pt.
2. controlled clinical trial.pt.
3. randomized.ab.
4. randomised.ab
5. placebo.ab.
6. randomly.ab.
7. trial.ab.
8. groups.ab.
9. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8
10. exp Breast Neoplasms/
11. (breast adj6 cancer$).mp.
12. (breast adj6 neoplasm$).mp.
13. (breast adj6 carcinoma$).mp.
14. (breast adj6 tumour$).mp.
15. (breast adj6 tumor$).mp.
16. 10 or 11 or 12 or 13 or 14 or 15
17. exp Reconstructive Surgical Procedures/
18. exp Breast Implants/
19. exp Prostheses and Implants/
20. exp Mammaplasty/
21. exp Surgical Flaps/
22. (breast adj6 reconstruct$).mp.
23. (breast adj6 reconstruct$ adj6 surger$).mp.
24. (breast adj6 reconstruct$ adj6 surgical adj6 procedure$).mp.
25. (immediate$ adj6 breast adj6 reconstruct$).mp.
26. (immediate$ adj6 breast adj6 reconstruct$ adj6 surger$).mp.
27. (immediate$ adj6 breast adj6 reconstruct$ adj6 surgical adj6 procedure$).mp.
28. (delay$ adj6 breast adj6 reconstruct$).mp.
29. (delay$ adj6 breast adj6 reconstruct$ adj6 surger$).mp.
30. (delay$ adj6 breast adj6 reconstruct$ adj6 surgical adj6 procedure$).mp.
31. 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30
32. exp Mastectomy/
33. (post$ adj6 mastectom$).mp.
34. 32 or 33
35. 9 and 16 and 31 and 34
36. limit 35 to humans
Appendix 2. EMBASE Search Strategy (Ovid SP format)
1. exp breast cancer/
2. breast tumor/
3. exp neoplasm/ and medullary.mp.
4. exp brocystic breast disease/
5. 1 or 2 or 4 or 3
6. exp breast/
7. breast.tw.
8. 7 or 6
9. (breast adj milk).ti,ab,sh.
10. (breast adj tender$).ti,ab,sh.
11. 9 or 10
12. 8 not 11
13. exp neoplasm/
14. 12 and 13
15. exp lymphedema/
16. 14 and 15
17. (breast adj25 neoplasm$).ti,ab,sh.
18. (breast adj25 cancer$).ti,ab,sh.
19. (breast adj25 tumour$).ti,ab,sh.
20. (breast adj25 tumor$).ti,ab,sh.
21. (breast adj25 carcinoma$).ti,ab,sh.
22. (breast adj25 adenocarcinoma$).ti,ab,sh.
23. (breast adj25 sarcoma$).ti,ab,sh.
24. (breast adj25 dcis).ti,ab,sh.
25. (breast adj25 ductal).ti,ab,sh.
26. (breast adj25 inltrating).ti,ab,sh.
27. (breast adj25 intraductal).ti,ab,sh.
28. (breast adj25 lobular).ti,ab,sh.
29. (breast adj25 medullary).ti,ab,sh.
30. or/17-29
31. 5 or 14 or 30 or 16
32. exp mastectomy/
33. 31 or 32
34. exp mammary neoplasms/
35. (mammary adj25 neoplasm$).ti,ab,sh.
36. (mammary adj25 cancer$).ti,ab,sh.
37. (mammary adj25 tumour$).ti,ab,sh.
38. (mammary adj25 tumor$).ti,ab,sh.
39. (mammary adj25 carcinoma$).ti,ab,sh.
40. (mammary adj25 adenocarcinoma$).ti,ab,sh.
41. (mammary adj25 sarcoma$).ti,ab,sh.
42. (mammary adj25 dcis).ti,ab,sh.
43. (mammary adj25 ductal).ti,ab,sh.
44. (mammary adj25 inltrating).ti,ab,sh.
45. (mammary adj25 intraductal).ti,ab,sh.
46. (mammary adj25 lobular).ti,ab,sh.
47. (mammary adj25 medullary).ti,ab,sh.
48. or/34-47
49. 33 or 48
50. (breast adj6 reconstruct$).mp.
51. (breast adj6 reconstruct$ adj6 surger$). ti,ab,sh.
52. (breast adj6 reconstruct$ adj6 surgical adj6 procedure$). ti,ab,sh.
53. (immediate$ adj6 breast adj6 reconstruct$). ti,ab,sh.
54. (immediate$ adj6 breast adj6 reconstruct$ adj6 surger$). ti,ab,sh.
55. (immediate$ adj6 breast adj6 reconstruct$ adj6 surgical adj6 procedure$). ti,ab,sh.
56. (delay$ adj6 breast adj6 reconstruct$). ti,ab,sh.
57. (delay$ adj6 breast adj6 reconstruct$ adj6 surger$). ti,ab,sh.
58. (delay$ adj6 breast adj6 reconstruct$ adj6 surgical adj6 procedure$). ti,ab,sh.
59. or/50-58
60. 49 and 59
61. exp controlled clinical trial/
62. comparative study/
63. drug comparison/
64. randomization/
65. crossover procedure/
66. double blind procedure/
67. single blind procedure/
68. placebo/
69. prospective study/
70. ((clinical or controlled or comparative or placebo or prospective or randomi#ed) adj3 (trial or study)).ti,ab.
71. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).ti,ab.
72. ((singl$ or doubl$ or trebl$ or trip$) adj7 (blind$ or mask$)).ti,ab.
73. (cross?over$ or (cross adj1 over$)).ti,ab.
74. or/61-73
75. 60 and 74
76. limit 75 to human
77. limit 76 to yr=2003 - 2010
Appendix 3. WHO ICTRP Search
WHO ICTRP Search (22/07/2010)
1. Title: breast reconstruction ORimmediate breast reconstruction OR immediate reconstruction ORdelay* breast reconstruction OR
delay* reconstruction OR postmastectomy OR postmastectomies OR post mastectomy OR post mastectomies OR post-mastectomy
OR post-mastectomies OR Latissimus Dorsi Myocutaneous Flap OR Latissimus Dorsi Myocutaneous Flaps OR TRAM Flap OR
TRAM Flaps OR Deep Inferior Epigastric Perforator Flap OR Deep Inferior Epigastric Perforator Flaps OR DIEP Flap OR DIEP
Flaps ORGluteal Artery Perforator ORGAP ORTransverse Rectus Abdominus Myocutaneous Flap ORTransverse Rectus Abdominus
Myocutaneous Flaps
Condition: breast cancer OR breast cancers OR breast carcinoma OR breast carcinomas OR breast neoplasm OR breast neoplasms
OR ductal carcinoma in situ OR DCIS
2. Condition: breast cancer OR breast cancers OR breast carcinoma OR breast carcinomas OR breast neoplasm OR breast neoplasms
OR ductal carcinoma in situ OR DCIS
Intervention: breast reconstruction OR immediate breast reconstruction OR immediate reconstruction OR delayed breast reconstruc-
tion OR delayed reconstruction OR postmastectomy OR postmastectomies OR post mastectomy OR post mastectomies OR post-
mastectomy OR post-mastectomies OR Latissimus Dorsi Myocutaneous Flap OR Latissimus Dorsi Myocutaneous Flaps OR TRAM
Flap OR TRAM Flaps OR Deep Inferior Epigastric Perforator Flap OR Deep Inferior Epigastric Perforator Flaps OR DIEP Flap OR
DIEP Flaps OR Gluteal Artery Perforator OR GAP OR Transverse Rectus Abdominus Myocutaneous Flap OR Transverse Rectus
Abdominus Myocutaneous Flaps
W H A T S N E W
Last assessed as up-to-date: 25 August 2010.
Date Event Description
9 July 2011 Amended Correctied minor topographical errors.
H I S T O R Y
Protocol rst published: Issue 9, 2010
Review rst published: Issue 7, 2011
C O N T R I B U T I O N S O F A U T H O R S
Nigel DSouza (ND), Geraldine Darmanin (GD) and Zbys Fedorowicz (ZF) were responsible for:
organising the retrieval of papers;
writing to authors of papers for additional information;
data collection for the review;
obtaining and screening data on unpublished studies.
ZF and ND were responsible for entering any extracted data into RevMan.
ZF and ND were responsible for the analysis and interpretation of data.
ND and ZF were responsible for:
screening search results;
screening retrieved papers against inclusion criteria;
appraising the quality of papers;
extracting data from papers;
designing the review;
co-ordinating the review; and
data management for the review.
All review authors contributed to writing the review.
ND is the guarantor for the review.
D E C L A R A T I O N S O F I N T E R E S T
There are no nancial conicts of interest and the authors declare that they do not have any associations with any parties who may
have vested interests in the results of this review.
S O U R C E S O F S U P P O R T
Internal sources
Cochrane Breast Cancer Group, Australia.
External sources
No sources of support supplied
D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W
In viewof the lownumber of studies eligible for inclusion we considered those studies in which immediate reconstruction was compared
with the option of delayed or no treatment.
I N D E X T E R M S
Medical Subject Headings (MeSH)
Breast Neoplasms [psychology;
surgery]; Mammaplasty [
methods; psychology]; Randomized Controlled Trials as Topic; Time Factors

MeSH check words
Female; Humans

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Immediate versus delayed reconstruction following surgery

for breast cancer (Review)

Indicates the major publication for the study

methods; psychology]; Randomized Controlled Trials as Topic; Time Factors

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