Subtotal Versus Total Abdominal Hysterectomy Randmoized Clinial Trial With 14-Year Questionnaire Follow Up

Research ajog.
org
GYNECOLOGY
Subtotal versus total abdominal hysterectomy:
randomized clinical trial with 14-year
questionnaire follow-up
Lea Laird Andersen, MD; Bent Ottesen, MD, DMSc; Lars Mikael Alling Møller, MD, PhD;
Christian Gluud, MD, DMSc; Ann Tabor, MD, DMSc; Vibeke Zobbe, MD; Elise Hoffmann, MD;
Helga Margrethe Gimbel, MD, DMSc; for the Danish Hysterectomy Trial Group
OBJECTIVE: The objective of the study was to compare long-term (Short Form-36 questionnaire), hospital contacts, and vaginal
results of subtotal vs total abdominal hysterectomy for benign uter- bleeding.
ine diseases 14 years after hysterectomy, with urinary incontinence as
RESULTS: The questionnaire was answered by 197 of 304 women
the primary outcome measure.
(64.8%) (subtotal hysterectomy [n ¼ 97] [63.4%]; total hysterectomy
STUDY DESIGN: This was a long-term follow-up of a multicenter, [n ¼ 100] [66.2%]). Mean follow-up time was 14 years and mean age
randomized clinical trial without blinding. Eleven gynecological at follow-up was 60.1 years. After subtotal abdominal hysterectomy,
departments in Denmark contributed participants to the trial. 32 of 97 women (33%) complained of urinary incontinence compared
Women referred for benign uterine diseases who did not have with 20 of 100 women (20%) after total abdominal hysterectomy 14
contraindications to subtotal abdominal hysterectomy were years after hysterectomy (relative risk, 1.67; 95% confidence interval,
randomized to subtotal (n ¼ 161) vs total (n ¼ 158) abdominal 1.02e2.70; P ¼ .035). After a multiple imputation analysis, this
hysterectomy. All women enrolled in the trial from 1996 to difference disappeared (relative risk, 1.36; 95% confidence interval,
2000 who were still alive and living in Denmark (n ¼ 304) 0.86e2.13; P ¼ .19). No differences were seen in any of the sec-
were invited to answer the validated questionnaire used in prior ondary outcomes.
1 and 5 year follow-ups. Hospital contacts possibly related to
CONCLUSION: Subtotal abdominal hysterectomy was not superior to
hysterectomy from 5 to 14 years postoperatively were regis-
total abdominal hysterectomy on any outcomes. More women seem to
tered from discharge summaries from all public hospitals in
have subjective urinary incontinence 14 years after subtotal abdominal
Denmark. The results were analyzed as intention to treat and
hysterectomy. This result was not confirmed by multiple imputation
per protocol. Possible bias caused by missing data was
analysis and should be interpreted cautiously.
handled by multiple imputation. The primary outcome
was urinary incontinence; the secondary outcomes were pelvic Key words: hysterectomy, long-term follow-up, pelvic organ prolapse,
organ prolapse, constipation, pain, sexuality, quality of life quality of life, urinary incontinence
Cite this article as: Andersen LL, Ottesen B, Alling Møller LM, et al. Subtotal versus total abdominal hysterectomy: randomized clinical trial with 14-year questionnaire
follow-up. Am J Obstet Gynecol 2015;212:758.e1-54.
From the Department of Obstetrics and Gynecology, Nykøbing Falster Hospital, Nykøbing Falster in
association with the University of Southern Denmark (Drs Andersen and Gimbel); Juliane Marie
A pproximately 4500 benign hyster-
ectomies are performed yearly in
Denmark.1 Although the use of the less
Center (Dr Ottesen), Department of Obstetrics and Gynecology (Drs Zobbe and Tabor), and
Copenhagen Trial Unit, Center for Clinical Intervention Research (Dr Gluud), Rigshospitalet, invasive laparoscopic mode of hysterectomy
Copenhagen University Hospital, Copenhagen; and Department of Obstetrics and Gynecology, is rising, 32% of Danish hysterectomies
Roskilde Hospital, Roskilde (Drs Alling Møller and Hoffmann), Denmark. in 2012 were abdominal,2 and more than
Received Sept. 9, 2014; revised Nov. 14, 2014; accepted Dec. 17, 2014. 50% of hysterectomies in the United
This long-term follow-up study was supported by the research foundation of Region Sjælland, States were abdominal in 2010.3
University of Southern Denmark, and the Department of Gynecology, Nykøbing Falster Hospital, Of abdominal hysterectomies, 10%
Rigshospitalet (Copenhagen University Hospital), and Roskilde Hospital, Denmark.
were subtotal, and of laparoscopic hys-
B.O. and H.M.G. are members of the board of the Danish Hysterectomy and Hysteroscopy terectomies, 20% were subtotal in
Database. The other authors report no conflict of interest.
Denmark in 2011.1 In some hospitals in
Presented in oral format at the 39th biannual meeting of the Nordic Federation of Societies of
Germany, subtotal laparoscopic hyster-
Obstetrics and Gynecology, Stockholm, Sweden, June 10-12, 2014, and as a poster at the 7th
annual congress of Leading Lights in Urogynecology, European Urogynecological Association, ectomy is the standard and accounts for
Athens, Greece, Oct. 2-4, 2014. more than 80% of laparoscopic hyster-
Corresponding author: L. L. Andersen, MD. lland@regionsjaelland.dk ectomies.4 The background for prefer-
0002-9378/$36.00 ª 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2014.12.039 ring subtotal hysterectomy is that it is
simpler and quicker and may result in
758.e1 American Journal of Obstetrics & Gynecology JUNE 2015

ajog.org Gynecology Research
fewer complications.5 However, mor- The sample size of the original trial women who reported UI at any time
cellation is part of this mode of hyster- was calculated based on an assumed since hysterectomy including prior
ectomy, and because leiomyosarcomas prevalence of the primary outcome, follow-ups.14,15
are sometimes mistaken for fibromas, UI, 1 year after TAH of approximately Secondary outcomes were hospital
morcellation is no longer recommended 23%.21,22 With a power of 0.80, a contacts, pelvic organ prolapse (POP),
by the Food and Drug Administration6; type I error of 5%, and a 15% abso- pelvic pain, satisfaction with sex life,
consequently, one may assume, in the lute difference in UI between the constipation, quality of life (QoL), and
future, large uteri will more often be surgical groups, 160 participants had vaginal bleeding after SAH. All out-
removed by abdominal hysterectomy. to be included in each intervention comes, except QoL, were dichotomized,
Studies in the 1980s7-9 suggested that group.14 and the SAH and TAH groups were
subtotal abdominal hysterectomy (SAH) Results from 1 year of follow-up14 compared using a c2 test. Analyses were
was superior to total abdominal hyster- showed that significantly more women conducted as intention to treat as well as
ectomy (TAH) regarding sexual func- in the SAH group were urinary inconti- per protocol excluding participants that
tion. This finding was not reproduced in nent compared with the TAH group. A did not receive the allocated intervention
randomized clinical trials (RCTs).10-12 decrease in UI after hysterectomy was (Figure 1). As in prior follow-ups,14,15
The risk of cervical cancer in the seen in both surgical groups. The sec- the conclusions are based on the
remaining cervix is another important ondary outcomes postoperative compli- intention-to-treat analyses. Additionally,
issue. Nevertheless, if a Papanicolaou cations, quality of life (Short Form-36 satisfaction with sex life was analyzed
smear is normal prior to surgery and the [SF-36]), constipation, pelvic organ separately for those stating they had a
woman continues to participate in cer- prolapse, satisfaction with sexual life, partner and those who did not.
vical cancer screening, the risk of cervical and pelvic pain did not show any dif- QoL was assessed by the validated SF-
cancer is only approximately 0.03%.14,15 ference between surgical groups. Neither 36 questionnaire25 included in our
Three RCTs comparable with our did the further analyses of lower urinary questionnaire (Supplemental Material).
Danish trial15,16 comparing SAH with tract symptoms23 and sexuality.13 At 1 SF-36 was scored according to the spec-
TAH16-18 have performed long-term year, 20% of the SAH group still expe- ifications by Quality Metric using the
follow-up and found no significant dif- rienced vaginal bleeding. At 5 years,15 official scoring software. For each
ferences between SAH and TAH on the significant difference between SAH participant a physical component score
clinical outcomes. Few data on long- and TAH regarding UI was reproduced. (PCS) and a mental component score
term outcomes after subtotal vs total The number of incontinent women was (MCS) were calculated. These scores are
laparoscopic hysterectomy are avail- higher than at 1 year. In the SAH group, validated and a norms based mean of 50
able.19 Although open abdominal and 11% still experienced vaginal bleeding. is interpreted as average QoL. Means
laparoscopic surgery differ in many All participants still alive and living in were compared between surgical groups
ways, the most recent Cochrane sys- Denmark in September 2012 were con- using the Wilcoxon rank sum test
tematic review20 on the topic included tacted by letter, and it contained the because the scores were not normally
both methods and stated that there was validated questionnaire24 (Appendix; distributed.
no evidence to support the shift toward Supplemental Material) used in prior Some women did not answer all
subtotal hysterectomy seen in laparos- follow-ups.14,15 The questionnaire questions resulting in different totals for
copy. The authors of the review conclude assessed primary and secondary out- each analysis. The number in each group
that more long-term follow-up is needed comes (presented in the following text). for the particular analysis is stated in
because urogenital problems may occur Reminders were sent 2 and 7 months Table 1. To account for possible bias
years after surgery, especially in post- later to nonresponders. Participants caused by missing data because of the
menopausal women.20 were encouraged to return the ques- loss to follow-up and incomplete ques-
We aimed to compare 14-year out- tionnaire unanswered if they did not tionnaires, multiple imputation (MI)
comes after SAH vs TAH in women wish to participate, thus avoiding re- was carried out using the FCS method in
included in a randomized clinical trial minders. Age at follow-up and follow-up SAS (version 9.3; SAS Institute, Cary,
for benign uterine diseases.14,15 The time was calculated with January 2013 as NC) using the PROC MI and MIANA-
primary outcome is urinary inconti- the cutoff point. LYZE functions. The 14-year outcomes
nence (UI) 14 years after hysterectomy. The primary outcome, UI, was imputed were UI, pelvic pain, POP,
defined as a subjective complaint of satisfaction with sex life, QoL, and
M ATERIALS AND M ETHODS involuntary loss of urine often or constipation.
In 1996e2000, 319 women from 11 gy- always (question 35 in the question- The following variables were included
necological departments in Denmark naire). Because this result could re- in the imputation model because they
were randomized to SAH vs TAH.14 flect a difference in treatment-seeking were associated with (P < .1) one or
Details about eligibility criteria, con- behavior between surgical groups more of the outcomes in the multivariate
sent, inclusion, randomization, and sur- rather than in the occurrence of UI, logistic regression: baseline variables in-
gical procedures have been published.14 we also analyzed the number of cluded type of surgery, number of
JUNE 2015 American Journal of Obstetrics & Gynecology 758.e2

Research Gynecology ajog.org
results.27 The QoL scores were not nor-

FIGURE 1 mally distributed, and despite using the
Flowchart of participants transformations of inverse, log, squared,
gamma, exponential, box cox, and beta,
we could not approximate the normality.
We entered the untransformed scores in
the MI model and analyzed them using
the Wilcoxon rank sum test. Because a
normal distribution is assumed in MI,
this could potentially skew other out-
comes. However, we ran the MI with and
without QoL included, and it had no
impact on other outcomes.
Hospital contacts were registered for
all randomized women by looking up all
discharge summaries from Danish pub-
lic hospitals from 5 years postoperatively
until July 2013 in the central registry of
discharge summaries. Any hospital
contact regarding abdominal, gyneco-
logical, urological (including UI), plastic
surgical, or dermatological complaints
were scrutinized. If the contact might be
related to the prior hysterectomy, it was
registered. Hospital contacts from the
time of surgery until 5 years post-
operatively have been published else-
where.14,15 Hospital contacts were
divided into the following categories:
recurrent urinary tract infection
(including pyelonephritis), pain, UI,
POP, cervical problems (bleeding or
dysplasia), other urogenital, skin prob-
lems/hernias, and others.
All data were handled and analyzed
using SASjmp version 10 statistical
The figure shows participants at each stage of the trial from randomization through all follow-ups and software (SAS Institute) except for MI,
reasons for dropouts. which was carried out in SAS version 9.3
SAH, subtotal abdominal hysterectomy; TAH, total abdominal hysterectomy. (SAS Institute).
Andersen. SAH vs TAH, RCT with 14 year follow-up. Am J Obstet Gynecol 2015. The original trial as well as this follow-
up was accepted by the regional ethics
committee journal number, SJ-268, as
well as the Danish Data Protection
deliveries, largest baby greater than 4000 precision in the analyses. The MI Agency journal number 2012-41-0286.
g, smoking more than 5 cigarettes per method assumes that missingness is
day, alcohol consumption greater than missing at random, meaning that R ESULTS
14 units per week (1 unit ¼ 12 g of missing data are related to other We contacted 304 women (95.3%)
alcohol), UI, pain, and constipation. observed variables but not to unob- (SAH: 153; TAH: 151); 10 (3.1%) had
Follow-up variables included were as served variables or to the missing died, from causes unrelated to hysterec-
follows: UI, pelvic pain, POP, con- items.26 The imputed datasets were tomy, and 5 (1.6%) had left Denmark.
stipation, satisfaction with sex life at 1 analyzed by a c2 test, and the pooled Two hundred forty-nine women (82%)
and 5 years, and physical (PCS) and analyses were carried out using the returned the questionnaire; however, 52
mental (MCS) QoL scores at 1 year. MIANALYZE function (SAS Institute). (17.1%) returned it blank stating that
One hundred imputed datasets were Relative risks were logarithmically they did not wish to participate. A total
created using a maximum of 100 itera- transformed before pooling to comply of 197 (64.8%) answered the question-
tions. This was chosen to obtain high with Rubin’s rules for pooling imputed naire (Figure 1).

TABLE 1
Primary and secondary outcome measures at 14 year follow-up intention-to-treat
Outcome Observed data Multiple imputation
(n [ SAH/TAH) SAH TAH RR 95% CI P value RR 95% CI P value
UI, % (n ¼ 96/100) 32 (33.3) 20 (20) 1.67 1.02e2.70 .035 a
1.36 0.86e2.13 .19
Constipation, % 14 (14.4) 7 (7) 2.06 0.87e4.89 .091 1.77 0.83e3.77 .14
(n ¼ 97/100)
Pelvic organ prolapse, 12 (12.9) 11 (11.3) 1.14 0.53e2.45 .74 0.97 0.50e1.86 .92
% (n ¼ 93/97)
Satisfied with 48 (64) 53 (67.9) 0.94 0.75e1.18 .61 1.09 0.76e1.58 .64
sexual life, %
(n ¼ 75/78)
Pelvic pain, % 14 (14.6) 10 (10) 1.46 0.68e3.12 .33 1.33 0.69e2.55 .40
(n ¼ 96/100)
Vaginal bleeding, % 0
(SAH only, n ¼ 97)
QoLb Mean (95% CI) Mean (95% CI)
SAH TAH
PCS mean (95% CI) 50.4 (48.5e52.4) 51.3 (49.4e53.2) .54 50.05 (48.5e51.6) 50.9 (49.1e52.8) .67
MCS mean (95% CI) 54.8 (52.9e56.7) 53.2 (51.4e55.1) .39 54.4 (52.5e56.1) 52.2 (50.7e54.2) .87
CI, confidence interval; MCS, mental component score; PCS, physical component score; QoL, quality of life; RR, relative risk; SAH, subtotal abdominal hysterectomy; TAH, total abdominal hys-
terectomy; UI, urinary incontinence.
a
Statistically significant; b Wilcoxon rank sum test.
Andersen. SAH vs TAH, RCT with 14 year follow-up. Am J Obstet Gynecol 2015.
The number of participants in the Analysis of multiple imputed data difference in satisfaction with sex life
groups was similar: 97 of 153 (63.4%) in showed no significant differences be- between SAH and TAH overall (Table 1)
the SAH group and 100 of 151 (66.2%) tween surgical groups regarding UI or when subdivided according to partner
in the TAH group. Characteristics of the (P ¼ .19) (Table 1). status (data not shown). The other sec-
participants and nonparticipants in this Neither the physical (PCS) nor the ondary outcomes are shown in Table 1.
follow-up (Table 2) did not differ ac- mental (MCS) score of the SF-36 QoL None of them showed significant dif-
cording to baseline variables from time questionnaire differed between the sur- ferences between surgical groups in the
of surgery except that fewer of the par- gical groups, and the means were analysis of observed data or in multiple
ticipants were smokers at the time of consistent with the expected mean of 50 imputation.
surgery and more participants had an (Table 1). None of the participants Hospital contacts from 5 to 14 years
alcohol consumption greater than 14 experienced vaginal bleeding at 14 years. after hysterectomy are shown in Figure 2.
units per week at time of surgery than Twenty-one women (11.5%) stated There was no significant difference in the
the nonparticipants. The 2 surgical they did not have a partner. Of these, 9 total number of hospital contacts (SAH,
groups of responders were comparable (42.9%) stated that they did not know 29 [17.7%] vs TAH, 18 [11.3%]; relative
(Table 2). Mean age at follow-up was whether they were satisfied with their sex risk, 1.57; 95% confidence interval,
60.1 years; mean follow-up time was 14.1 life. Six (28.6%) stated they were satis- 0.91e2.71; P ¼ .10).
years. fied and 6 (28.6%) stated they were not.
More women in the SAH group (32 of Among those with a partner (n ¼ 162, C OMMENT
97, 33.3%) than in the TAH group (20 of 88.5%), 22 (13.6%) did not know On observed data, we found that more
100, 20%) reported UI often or always whether they were satisfied with their sex women had UI after SAH than after
(P ¼ .035) (Table 1). The difference was life, 94 (58%) were satisfied, and 46 TAH 14 years after surgery. This is
also significant in the per-protocol (28.4%) were not. Those who stated they consistent with prior results from our
analysis (P ¼ .024) (Table 3). Table 3 did not know whether they were satisfied trial.14,15 At 14 years, the percentage of
also shows the other analyses of UI as were excluded from the analysis of UI in the TAH group has reached
described in the Materials and Methods satisfaction with sex life in the 2 surgical approximately the prehysterectomy
section. groups (Table 1). There was no level, whereas the percentage in the SAH

TABLE 2
Characteristics for responders and nonresponders as well as the responders divided into surgical groups
Participants Nonparticipants SAH participants TAH participants
Characteristic (n [ 197) (n [ 122) P value (n [ 97) (n [ 100)
Age, y (SD) 60.1 (5.8) 60.5 (6.6) .58 60.7 (5.9) 59.6 (5.6)
Follow-up time, y (range) 14.1 (12e16) 14.04 (12e16) .77 14.2 (12e16) 14.03 (12e16)
Parity (range) 1.8 (0e5) 1.74 (0e5) .58 1.85 (0e5) 1.76 (0e4)
2 a
BMI, kg/m (SD) 26.1 (6.7) 25.5 (4.6) .38 26.45 (7.1) 25.71 (6.3)
Indication for hysterectomy, %
Fibroids 115 (58.4) 70 (57.4) .86 58 (59.8) 57 (57.0)
Abnormal uterine bleeding 63 (31.9) 42 (34.7) .59 29 (29.9) 34 (33.6)
Dysmenorrhea 8 (4.1) 4 (3.31) .74 3 (3.1) 5 (4.9)
Pelvic pain 9 (4.6) 4 (3.31) .58 6 (6.2) 3 (2.9)
Endometriosis 0 1 (0.83) .16 0 0
Other 2 (1.02) 1 (0.83) .87 1 (1.03) 1 (0.99)
Type of surgery, %
SAH 97 (49.2) 64 (52.5) .58
TAH 100 (50.8) 58 (47.5) .58
Smoking >5 cigarettes 46 (23.4) 57 (46.7) < .0001 18 (18.6) 28 (28.0)
per day, %b
Alcohol >14 units 22 (11.2) 6 (4.9) .047 13 (13.4) 9 (9.0)
per week , %b,c
Chronic disease, %d 97 (49.2) 25 (29.4) .0018 49 (50.5) 48 (48.5)
Preoperative UI, % 48 (25.0%) (n ¼ 192) 20 (17.4%) (n ¼ 115) .110 26 (27.7%) (n ¼ 94) 22 (22.2%) (n ¼ 99)
BMI, body mass index; SAH, subtotal abdominal hysterectomy; TAH, total abdominal hysterectomy; UI, urinary incontinence.
a
BMI at follow-up for participants but baseline for nonparticipants; b At time of surgery; c A unit of alcohol, in Denmark, is defined as 12 g of alcohol, which is the approximate content of a normal
beer or a glass of wine; d At 14 year follow-up for participants and at 1 year for nonparticipants.
group is now higher.14 However, the MI baseline data do not suggest systematic difference regarding UI or any other
analysis did not show a significant dif- differences. The internal validity could outcomes. This might reflect that there
ference. No significant differences were be compromised if an imbalance was truly is no difference, and our observed
found between SAH and TAH on the seen in responders between intervention finding may be caused by attrition bias.
secondary outcomes. groups. However, the responders in the 2 Alternatively, the uncertainty incorpo-
The strengths of the present results are surgical groups are comparable accord- rated in MI (within imputation variance
that they represent the largest random- ing to baseline characteristics. and between imputation variance)26 in-
ized clinical trial on the topic and have None of the reasons given for not creases with the percentage of missing
the longest follow-up time. The Danish participating were related to the hyster- data and yields wider confidence intervals
social security number enabled us to ectomy method. Explanations of our low leading to nonsignificant results. A third
locate all participants and look up hos- response could be the loss of interest explanation of the difference between our
pital contacts for everyone. because of the long follow-up, older age, observed and MI results could be an
One limitation of this follow-up is the or medical conditions making it over- unknown confounding factor related to
low response, which might compromise whelming to be asked to participate. In missingness as well as UI, meaning that
the external validity of the trial. Non- addition, according to the ethics com- our assumption of missing at random is
responders might differ in a systematic mittee, we were allowed to contact par- incorrect, and the data are truly missing
way from responders, meaning that our ticipants by letter only. Contact by not at random. In this case, the MI
sample at follow-up is less representative telephone was allowed in earlier follow- analysis is not valid.26 Our observed
of the population than the original trial ups14,15 as well as in a comparable trial.16 findings correspond well with prior
sample. Other than smoking and alcohol We used MI to handle missing data. follow-ups of this trial with higher
consumption at the time of surgery, our This analysis showed no significant response proportions.14,15 The relative

TABLE 3 FIGURE 2
Analyses of urinary incontinence Hospital contacts from 5 to 14
Urinary incontinence years after hysterectomy
(n [ SAH/TAH) SAH (%) TAH (%) RR 95% CI P value
Questionnaire only (n ¼ 97/100) 32 (33.3) 20 (20) 1.67 1.02e2.70 .035a
Questionnaire or prior treatment 34 (35.4%) 23 (23%) 1.54 0.98e2.41 .056
for UI according to discharge
summaries (n ¼ 97/100)
Questionnaire at any time point 67 (41.6%) 49 (31%) 1.34 1.0e1.80 .049a
(all participants in RCT)
(n ¼ 161/158)
Questionnaire at any time point 45 (46.9%) 31 (31%) 1.51 1.05e2.17 .023a
(only those who answered 14 year
follow-up) (n ¼ 96/100)
Per protocol (n ¼ 84/88) 29 (34.5) 17 (19.3) 1.78 1.06e3.00 .024a Bar chart of hospital contacts possibly related to
CI, confidence interval; RCT, randomized controlled trial; RR, relative risk; SAH, subtotal abdominal hysterectomy; TAH, total the prior hysterectomy. Contacts are divided into
abdominal hysterectomy; UI, urinary incontinence.
categories and are shown for each hysterectomy
a
Statistically significant.
group separately.
UTI, urinary tract infection.
Andersen. SAH vs TAH, RCT with 14 year follow-up. Am J
Obstet Gynecol 2015.
risk found in MI for UI is the same as it et al18 a response of 82% (n ¼ 151), and
was in the 5 year follow-up15; however, in Greer et al16 a response of 27.4% (n ¼
that analysis the value was P ¼.052, much 37). Our response of 64.8% (n ¼ 197) is Like comparable trials,16-18 we found
closer to a statistically significant result. comparable with these. None of the other no difference in QoL between surgical
This could reflect the increased uncer- long-term follow-ups16-18 included MI groups. QoL scores were similar to our 1
tainty because of the higher percentage of or other ways of handling missing data, year follow-up.14 QoL is important when
missing data as explained above. meaning that possible attrition bias was treating benign diseases, and a stable
Another limitation of the trial is the not elucidated in these trials. A meta- score after 14 years is a good outcome for
lack of blinding. This has been discussed analysis including all long-term RCTs the participants.
in prior follow-ups.14,15 and taking attrition bias into account Up to 14 years after hysterectomy, we
Long-term follow-up of SAH vs TAH would be of great interest. still saw hospital contacts possibly
has been completed in 3 other RCTs.16-18 Our trial included white women only, related to hysterectomy. We found a
The longest follow-up was 11.3 years,18 and therefore, our results cannot be nonsignificant tendency toward more
with a mean age of 57 years. These trials readily transferred to populations of hospital contacts in the SAH group. No
found no significant differences in the mixed ethnicity. The prevalence of UI other long-term follow-ups16-18 have
outcomes studied. Persson et al18 saw a differs between ethnic groups; stress UI looked at this outcome.
tendency toward worse outcomes after is less common in women of African None of the women had vaginal
SAH than after TAH and concluded that descent.28,29 This could explain the dif- bleeding at 14 years. At 5 years,15 11% of
this might have been significant if the ference between our results and those of the women in the SAH group experi-
study had sufficient power or longer Thakar et al17; their population was enced vaginal bleeding. Natural meno-
follow-up. Our trial is larger and has mixed and one third of the population pause is the main reason for the
longer follow-up, and we found a signif- was of African descent. difference in results from 5 to 14 years.
icant difference in UI. We also looked at One theory to explain our finding of Only one woman had her cervix
the number of incontinent women at any more UI in the SAH group is that the removed since last follow-up, and this is
time point to see whether the difference method of suspension of the vagina used included in the cervical problems cate-
found at 14 years was a difference in in SAH and TAH might differ; no in- gory in Figure 2.
occurrence of UI or a difference in structions regarding suspension were Other outcomes might be important
treatment-seeking behavior between sur- given to the surgeons. The suspension after laparoscopic hysterectomy such as
gical groups. This analysis also showed performed in TAH might yield more vaginal dehiscence in total laparoscopic
significantly more women with UI in the support than the woman’s own connective hysterectomy and leiomyosarcomas and
SAH group than the TAH group. tissue, spared in SAH, which might lead to other complications to morcellation af-
The comparable trials also had stress UI in the SAH group. A further ter subtotal laparoscopic hysterectomy.
missing data. Thakar et al17 had a investigation of how suspension is per- RCTs with long-term follow-up are
response of 65% (n ¼ 181), Persson formed might elucidate this. needed to compare subtotal vs total

laparoscopic hysterectomy to shed light design of the long-term follow-up with L.L.A. and 13. Jacoby VL. Hysterectomy controversies:
on these outcomes unless the subtotal H.M.G. All of the authors critically revised the ovarian and cervical preservation. Clin Obstet
article and approved the final manuscript. The Gynecol 2014;57:95-105.
approach is stopped because of morcel- Danish Hysterectomy Trial Group participated in 14. Gimbel H, Zobbe V, Andersen BM,
lation issues.6 The percentage of hyster- recruiting and randomizing the participants. The Filtenborg T, Gluud C, Tabor A. Randomised
ectomies performed abdominally has local ethics committees of the participating controlled trial of total compared with subtotal
been declining.1,2 The recent discussion centers (Bornholm, Frederiksborg, Roskilde, hysterectomy with one-year follow up results.
of morcellation6 could mean a return to Storstrøms, and Vestsjællands Counties, journal BJOG 2003;110:1088-98.
number 1995-1-65) and the Danish Data Pro- 15. Andersen L, Zobbe V, Ottesen B, Gluud C,
abdominal hysterectomy for large uteri tection Agency had accepted the design of the Tabor A, Gimbel H. Five-year follow up of a
and an increase in vaginal hysterectomy randomized clinical trial before the recruitment of randomised controlled trial comparing subtotal
for smaller uteri. patients as well as the current follow-up. The with total abdominal hysterectomy. BJOG 2014
In conclusion, on observed data, more regional ethics committee in Region Sjaelland [Epub ahead of print].
women were urinary incontinent after accepted the design of the long-term follow-up 16. Greer WJ, Richter HE, Wheeler TL, et al.
(journal number SJ-268). Long-term outcomes of the Total or Supra-
SAH compared with TAH; however, this cervical Hysterectomy (TOSH) Trial. Female
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