DEPARTMENT OF GENERAL SURGERY FACULTY OF

MEDICINE & HEALTH SCIENCES

SGT MEDICAL COLLEGE, HOSPITAL& RESEARCH
INSTITUTE
BUDHERA, GURGAON-122505, HARYANA

PROTOCOL FOR SUBMISSION OF PLAN OF THESIS

FOR THE AWARD OF MS (GENERAL SURGERY)
SGT UNIVERSITY
SESSION 2018-2021

Name of the student Dr. Akhil Kumar Kainth

Date of joining MS 25th / MAY /2018

course
Title of thesis To   compare   the   outcome   of     diathermy   incision
versus scalpel incision in patients undergoing open
cholecystectomy

Name and address of Dr. Pawan Tiwari

supervisor
Professor& Head
Department Of General Surgery
Faculty of Medicine & Health Sciences
SGT Medical College, Hospital and Research
institute

Name and address of Dr. P.N Aggarwal

co-supervisor Professor
Department of General Surgery
Faculty of Medicine & Health Sciences
SGT Medical College, Hospital and Research
institute

Signature of candidate
 FACULTY OF MEDICINE & HEALTH SCINCES
SGT MEDICAL COLLEGE, HOSPITAL& RESEARCH
INSTITUTE
BUDHERA, GURGAON-122505, HARYANA

DEPARTMENT OF GENERAL SURGERY

CERTIFICATE OF SUPERVISOR

This is to certify that the facilities for the work on the subject of thesis
entitled
“To compare the outcome of diathermy incision versus scalpel
incision in patients undergoing open cholecystectomy.” are available
in this institution. The candidate shall be guided in this work and it will
be ensured that the work is done by the candidate him/herself and that the
data included in the thesis are genuine. It is also certified that no work to
the best of our knowledge has been done on this topic in this institution
earlier.

Signature of Supervisor Signature of co-Supervisor

Dr. Pawan Tiwari Dr P.N Aggarwal

Professor& Head Professor

Department Of General Surgery Department Of General Surgery
Faculty of Medicine & Health Sciences Faculty of Medicine & Health Sciences
SGT Medical college ,hospital and SGT Medical college ,hospital and
research institute research institute
 FACULTY OF MEDICINE & HEALTH SCINCES
SGT MEDICAL COLLEGE, HOSPITAL& RESEARCH
INSTITUTE
BUDHERA, GURGAON-122505, HARYANA

This study titled - “To compare the outcome of diathermy incision

versus scalpel incision in patients undergoing open cholecystectomy.”
is approved by Institutional Research committee and Institutional Ethics
committee

Signature of chairman of Signature of Secretary of

Institutional Research committee Institutional Ethics Committee

Signature of Dean
 Introduction

Incision is a cut or slit to gain access to the underlying structures(1). Very

few operations can be performed without cutting through the skin.

Traditionally skin incisions are made with stainless steel scalpels ,these
incisions are supposed to be more bloody and painful , skin bleeds
obscures the operating field which results in wastage of operating time.
To overcome this problem many advanced techniques have come like
laser , plasma scalpel cavitron surgical aspirator but the above said
methods are costly and relatively unavailable at peripheries.

Surgeons have been in search for ideal method of skin incision which
would provide quick and adequate exposure with minimal blood loss.

Cauterization is a medical term describing burning of body to remove or

close a part of it.

Electrosurgical devices stand out to be the most useful and most used
instruments in a surgeon’s armamentarium.

Electrocautery is available in all surgical theaters , however common

practice by most surgeons is still to make skin incision by scalpel and
divide the underlying deeper tissue by coagulation diathermy.

Nevertheless diathermy is used by some surgeons for skin incision(2).

Cutting diathermy incises the skin with little charring and necrosis as
compared with coagulation diathermy which generates heat more slowly
via a interrupted current output.

This study is undertaken to alleviate the fear of using electrocautery for

skin incision in open cholecystectomy cases.
                                Review of literature

Since the improvement in electrosurgical equipments and advent of

oscillatory units, diathermy has been excessively used for hemostasis
and subcuticle dissection. Its use for making skin incision has not gained
generalized acceptance. Earlier studies conducted on animals revealed
lateral thermal injuries with thermal knives that resulted in delayed
wound healing when compared with standard steel scalpel(3,4)

A study conducted by Lawrenson KB, Stephens FO (5) in 1970 revealed no

apparent difference in tensile strength between scalpel incisions and
electrocautery incisions at 1 week , although there was a histological
difference at 1 month. No microscopic or histological difference could be
observed between the two groups.

Kumagai .S .G, Rosales RF, Hunter GC, RappaportWD, Witzke DB, Chvapil
TA et al(6) in 1991 ,Department of surgery , University medical Center
Tucson , Arizona conducted study stating effects of electrocautery on
midline laparotomy wound infection.In this study they compared the
healing of midline fascial incisions made with either scalpel or
electrocautery and inoculated with e.coli in 57 Sprague Dawley rats. At
seventh day tensile strength was significantly less when incision were
made with electrocautery than with scalpel. Additionaly wound strength
was inversely proportional to concentration of inoculum of E.coli. The
use of electrocautery was also associated with more frequent
bacteremia at 48 hrs and higher mortality at 7 days. Their result
suggested that technique used to incise the abdominal fascia
subsequently effects wound healing particularly in infected wound.

Another study conducted by Pearlman, Stiegmann GV, Vance V, Norton

LW, Bell RCW, Staerkel R et al(7) in 1991 has shown that scalpel incisions
are associated with greater blood loss. No difference in the number of
wound seroma/ infection were noted between the treatment group.

Groot G, Chappell W (8) in 1994 conducted a prospective randomized

blinded trial to determine whether electrocautery incision in abdomen
and thorax increases the infection rates. They noticed wound infection in
15% of the patients when incision was made by scalpel and in 12%
patients when incision was made by electrocautery.

In the year 2001 ,Franchi M, Ghezzi F, Benedetti-Panici PL, Melpignano

M, Fallo L, Tateo S et al(9) performed a study on use of cold scalpel and
electrocautery for midline abdominal incisions.

The conclusion of the study was that choice of incision depends on the
surgeon as no significant difference was found in the comparison
conducted. Also the study concluded that electrocautery can be safely
used for skin incisions

Kearns S.R, Connolly EM, McNally S, McNamara DA, Deasy J(10) in 2001
studied diathermy versus scalpel incision in patients undergoing midline
laparotomy incision.In conclusion they mentioned that incision with
diathermy is faster with less blood loss, lower post-operative pain and no
significant difference in post- operative wound complications.

A Study was conducted by Chaudhary N.A, Wani NA, Ganai NA, Naqash
SH, Peer GQ, Wani QA (11) in the department of General Surgery, Sher E
Kashmir Institute of Medical Sciences, Srinagar in 2002. It was a
prospective study 240 female patients undergoing cholecystectomy were
randomized into two groups - A and B. In Group A skin incision was taken
with scalpel and in Group B skin incision was taken with electrocautery.
In this study they have concluded that diathermy incisions are quite safe
and significantly less painful and produce cosmetically better scar. They
recommended wider use of electrocautery and further evaluation of
study.
In 2002, experimental study of Skin Incision made by Scalpel and
Electrocautery was conducted on rats by Cervantes-Sanchez CR, Serrano-
Rico E, Rojero-VJ, Lazos-OM, Gutierrez-VR. (12). Objective of the study
was to compare scalpel against electrocautery to create dermal
incisions.In the study, they measured skin color, gross appearance,
elevation over dermis as well as inflammatory infiltrates, amount of
fibroblast and collagen deposition after 6 weeks of creation of incision.
Results showed that incisions created with both scalpel and
electrocautery were macroscopically indistinguishable in color, gross
appearance and elevation over dermis. With regard to histological
evaluation, there was no statistical difference between the two groups.
In conclusion, the authors stated that same result was obtained when
incising a rat's skin with scalpel or with electrocautery, after six weeks of
observation. And electrocautery can be safely used for skin incision.

A study was conducted in 2003 in porcine model by Pollinger H.S,

Mostafa G, Horold KL, Austin CE, Kercher KW, Mattews BD(13), the study
was named 'Comparison of wound healing characteristics with feedback
circuit electrosurgical generators in a porcine model'. In this study
eighteen pigs were evaluated by creating incisions over skin, intestine
and uterus using electrocautery and scalpel blade. All incisions were re
approximated with absorbable sutures. Incision sites were evaluated
histologically at 3, 7 and 14 days post incision according to
randomization. Skin and small intestine were compared at 7 and 14 days
for tensile strength. Results of the study stated that there was no
difference in tensile strength of two groups. Electrocautery showed
decreased overall wound healing at 3, 7 and 14 days.The Study
concluded that even though wound healing is delayed with
electrocautery group, the overall tensile strength of the wound is
unaffected.

Sheik B (14) at Neurosurgery Department, King Faisal University, Saudi

Arabia in 2004 performed a study stating safety and efficacy of
electrocautery incision for skin opening in neurosurgery. Results of
the study stated that blood loss is less with electrocautery incision and
only two patients had wound infection and dehiscence, rest all others
had normal wound healing. The study recommends use of
electrocautery for neurosurgical procedures to incise skin whenever
blood loss is expected.

Stolz A.J , Schutzner J, Lischke R, Simonek J, Pafko P. (15) performed a

study titled 'Is a scalpel required to perform a thoracotomy?' The Study
was conducted in 2004.The conclusion of the study was that the choice
of instrument for incising skin is surgeon's preference.

Meka P.N, Khullar P, Anand VJ (16) in 2004 compared the superiority of

electrocautery over scalpel incisions in various abdominal surgeries. This
study was designed to assess whether electrocautery can be
used for incising skin in various abdominal operations. A
prospective analysis of 60 patients was done. The age of the patients
included in the trial ranged from age 15 to 60 years . The patients were
randomized into two groups, namely "incision by scalpel'' and "incision
by electrocautery".The parameters used to for comparision were the two
primary were pain (on the visual analog scale}, blood loss from the
incision, time taken to make the incision, incidence of postoperative
wound infection and finally the cosmetic appeal upon follow-up. The
results showed significantly less blood loss as well as less pain scores
associated with electrocautery incisions over scalpel incisions. The
electrocautery incisions also took less time to make. Although the time
taken and the blood loss did not attain statistical significance in the
Midline abdominal incisions, the results still favored use of
electrocautery in midline as well as other incisions. Postoperatively, the
rates of wound infection were comparable in both techniques. The
cosmetic appeal was superior in the incisions that employed use of
electrocautery.

Chrysos E. , Athanasakis E, Antonakakis S, Xynos E, Zoras O (17) in 2005

compared diathermy and scalpel incision in tension free inguinal
hernioplasty at department of General Surgery in University Hospital
Heraklion Greece. Parameters measured included blood loss during skin
incision and underlying tissue dissection, post-operative pain and
requirement of analgesics, presence of wound dehiscence and wound
infection i.e. on the day of discharge, on the day of stapler removal and
after 1 month. The conclusion of the study was that skin incision with
diathermy is as safe as the use of scalpel in terms of wound healing and
it also reduces the analgesic requirement in post-operative period.

Another Study was conducted in Dublin, Ireland by Pollinger HS,

Mostafa G, Horold KL, Austin CE, Kercher KW, Mattews BD(18) in 2007.
Aim of the study was to compare the traditional opening using scalpel to
incise all layers with diathermy. Intra operative parameters like time
taken to open the wound, wound length and wound depth, wound
related blood loss and total operative blood loss were measured.
Results of the study showed that operative blood loss is 30% in scalpel
group as compared to diathermy group where the blood loss was 18.5
%. Study recommends the use of diathermy for hip hemiarthroplasty
which significantly reduces the blood loss and incidence of post-
operative wound complication.

Chau J.K., Dzigielewski P, Mlynarek A, Cote ow, Allen H, Harris JR et al (19)

division of Otolaryngology - Head and neck Surgery, University of
Alberta, Canada in 2009 conducted a study entitled 'Steel scalpel versus
electrocautery blade: comparison of cosmetic and patient satisfaction
outcomes of different incision methods.' In this study they compared
scalpel versus electrocautery incisions for bilateral neck dissections for
cosmetic and patient satisfaction outcomes and concluded that steel
scalpel or electrocautery may be used to incise the skin of patients
undergoing bilateral neck dissection with no difference in cosmetic
appeal or patient satisfaction outcome. The steel scalpel yields greater
incision related blood loss compared with electrocautery.
Ali Q, Siddique K, Mirza S, Malik AZ(20) in 2009 conducted the following
study - Comparison of superficial surgical site infection following use of
diathermy and scalpel for making skin incision in inguinal hernioplasty.
The study concluded that, the use of diathermy for making skin incisions
is as safe as scalpel and there is no significant difference amongst both
regarding wound infection.

Shamim M(21) in 2009 studied 'Diathermy vs scalpel skin incisions in

general surgery: double-blind, randomized, clinical trial’. The result
reached was that the Incision time was significantly longer in case of
scalpel incision, also incision blood loss was more in case of scalpel
group. Pain perception was found to be markedly reduced during the
first 48 hrs in diathermy incision group of patients. Total period of
hospital stay and time for complete wound healing were almost the
same for both groups. Postoperative complication rate by wound
classification did not differ markedly between the two groups. The
conclusion of the study was that diathermy incision has significant
advantages compared with the scalpel because of reduced incision time,
less blood loss, and reduced early postoperative pain.

Eren, Balik E, Ziyade S, Yamaner S, Akyuz A, Bugra D(22) from Istanbul, in

2010 in compared the early postoperative and late-term wound
complication rates between the scalpel and electrocautery in patients
with gastrointestinal malignancies undergoing midline abdominal
incisions. The study concluded that scalpel and electrocautery are similar
in terms of early postoperative and late-term wound complications
when used to perform midline abdominal incisions. Therefore, the
choice of method remains a matter of the surgeon's preference.

Ahmad N.Z., Ahmed A (23) in 2011 studied 'Meta-analysis of the

effectiveness of surgical scalpel or diathermy in making abdominal skin
incisions' with a view to compare the effectiveness of both the
techniques and address the common faults about diathermy incisions.
Conclusion of the study was that diathermy incisions are equally prone
to get wound infection as do the incisions made with scalpel.
Furthermore, lower incidence of early postoperative pain, swiftness of
the technique, and a reduced blood loss are the encouraging facts
supporting routine use of diathermy for abdominal skin incisions after
taking careful precautions.

A comparative study of scalpel and surgical diathermy incision in elective

operations of head and neck cancer by Kumar V, Tewari M, Shukla HS (24)
was conducted in 2011 . The aim of the study was to assess the outcome
of patients following use of scalpel or surgical diathermy in elective skin
incision of head and neck cancer. The study concluded that there was no
change in wound complication rate and scar formation even after
application of heat during use of surgical diathermy. Therefore, surgical
diathermy is safe and as effective as scalpel during elective skin incisions
of head and neck cancer.

Ly J, Mittal A , Windsor J (25) in 2012 conducted a study named

‘Systematic review and meta- analysis of cutting diathermy versus
scalpel for skin incision.’ The aim of this meta-analysis was to compare
skin incisions made by either scalpel or cutting diathermy. The study
concluded that skin incisions made by cutting diathermy are quicker and
are associated with less blood loss than those made by scalpel, and
there were no differences in the rate of wound complications or
postoperative pain.

A study was conducted by Chalya P.L. , Mchembe MD, Mabula JB,

Gilyoma JM(26) at Tanzania in 2013 titled 'Diathermy versus Scalpel
incision in elective midline laparotomy: A prospective randomized
controlled clinical study.' The aim of this study was to compare the
efficacy and safety of surgical diathermy incisions versus conventional
scalpel incisions for midline laparotomy with an aim to evaluate
diathermy as an effective alternative to scalpel incision. The study
concluded that diathermy incision in elective midline laparotomy
has significant advantages compared with the scalpel because of
reduced incision time, less blood loss, reduced early postoperative pain
and analgesic requirements.

'Randomized double-blind trial comparing the cosmetic outcome of

cutting diathermy versus scalpel for skin incisions' was conducted by
Aird LNF, Bristol SG, Phang PT, Raval MJ, Brown CJ(27) in 2015. Wound
infection rates and postoperative incisional pain were also compared.
The following conclusion was made “Cutting diathermy is a cosmetically
acceptable technique for abdominal skin incisions. There is no increased
risk of wound infection, and diathermy may convey benefit in terms of
early postoperative wound pain.”

In 2015, Talpur A.A, Khaskheli AB, Kella N, Jamal A.(28) conducted a study
named 'Randomized Clinical Trial on Diathermy and Scalpel Incisions in
Elective General Surgery.' The aim of this study was to examine incisional
time, blood loss during incision and postoperative wound complications
and pain with both methods of skin incision. The study concluded that
diathermy incision is a safe technique. It takes less time than scalpel
incision and the amount of blood loss is also on the lower during
incision. Diathermy is associated with less postoperative pain and less
complication as compared to scalpel incision. Thus diathermy should be
the method of choice in general elective surgery.

Aim and objectives

Aim :

To define which modality among scalpel or electrocautery used for

incisions is ideal , and has better advantages and lesser complications
compared to the other modality.

Objective :

To evaluate and compare the

1. Incision time

2. Incision related blood loss

3. Post-operative complications

in electrocautery and scalpel incision in patients undergoing open

cholecystectomy
 Material and methods

This will be a prospective study comprised of a randomized control trial

proposed to be conducted in the department of General Surgery, SGT
Medical College Hospital and Research Institute, Gurugram, Haryana

Patients who will present to our surgical department with features

suggestive of cholelithiasis will be considered for the study. The study
will be explained in detail to the patient. There after informed written
consent will be obtained from the willing participants and only then the
patients will be enrolled in the study.

TYPE OF STUDY- Prospective interventional randomized double blind

control study

SAMPLE SIZE- 100

INCLUSION CRITERIA-

1. Age more than 18 years (Adult).

2. Patients with findings suggestive of cholelithiasis in USG.

3. Patients willing to go for open cholecystectomy as the choice of
treatment instead of Laparoscopic Cholecystectomy.

4. Patient must be in relative good health and have adequate nutrition.

5. Patients of all races and genders will be included.

EXCLUSION CRITERIA-

1. Age less than 18 years

2. Patients on anticoagulation therapy

3. Patients with known allergy to cephalosporin antibiotics

4. Cardiac patients on pacemakers

5. Patients with chronic diseases expected to affect wound healing, such

as diabetes , hypertension, liver diseases , chronic anemia , renal
impairment

6. Patients with previous history of hypertropic or keloid scarring.

7. Patients who use tobacco products.

8. Patients who refuse consent for diathermy incision.

9. Patients who were lost on follow up.

Methodology-

Patients undergoing open cholecystectomy will be recruited in the study.

Patients will be randomly divided into two groups. A written consent will
be taken from the patients.

Group 1 (total 50 patients) will undergo surgery by using diathermy in

cutting mode for making skin incision. A monopolar diathermy using a
pen electrode and delivering 500 kHz of sinusoidal current will be used
in the procedure.

Group 2 (total 50 patients) will undergo surgery by using cold steel

scalpel for making skin incision, incising the muscles and opening of the
peritoneum.

Diathermy in coagulation mode will be used to secure hemostasis in

both groups.

Open cholecystectomy will be performed through a sub costal incision of

about 5 to 7 cm.

Prophylactic antibiotics (ceftriaxone/ cefotaxime/ cefoperazone +

salbactum) will be given 1hr prior to the operation and continued post
operatively till 2nd postoperative day.
Incision time will be noted from the start of making skin incision till
complete opening of the peritoneum

Blood loss during this step of the surgery will be noted by using pre
weighted dry gauze packs.

The muscles and peritoneum will be closed with vicryl 2/0, where as skin
will be closed with silk 2/0.

Postoperative analgesia will include injection diclofenac 50mg , which

will be administered on patients demand. Injectable analgesics will be
continued till postoperative day 2 after which the demand will be shifted
to oral analgesics i.e tab aciclofenac 50mg with paracetamol 500mg.

Visual pain scoring according to visual analog scale will be done each
morning till postoperative day 3.

Wound healing will be classified on the basis of ASEPSIS wound scoring

system as described by Wilson AP et al.

Category of infection: total score 0 to 10 = satisfactory healing;

11 to 20= disturbance of healing; 21 to 30= minor wound infection; 31 to

40 = moderate wound infection.
Postoperative wound complications such as superficial burns,
hematoma/ seroma formation , wound sepsis, wound dehiscence,will
be observed on 3rd day, 7th day, 14th day and at completion of 1 month

The stitches will be removed on 7th postoperative day

In case of infection wounds will be dressed till they heal by secondary

intention or re-suturing.

Formation of hypertrophied scar will be seen till 6 months

Final healing of the wound will be noted at 6 month of follow up.

References
1. Miachael JZ, Stanley WA. Maingot's Abdominal Operations 11th
edition MC Graw Hill publications Chapter 4; 71. 2007.

2. Margaret Farquharson and Brandan Moran. Farquharson's text book

of operative general surgery ninth edition 2005 Edward Arnold
publishers Ltd. Chapter 1; 1 - 2.

3. Sowa DE, Masterson BJ, Nealon N, von Fraunhofer JA. Effects of

thermal knives on wound healing. Obstet Gynecol. 1985; 66(3):436-92. Ji
GW, Wu YZ, Wang X, Pan HX, Li P,Du WY et al. Experimental and clinical
study of influence of high-frequency electric knives on healing of
abdominal incision. World J Gastroenterol. 2006 Jul 7; 12(25):4082-5.

4. Sowa DE, Masterson BJ, Nealon N, von Fraunhofer JA. Effects of

thermal knives on wound healing. Obstet Gynecol. 1985; 66(3):436-92. Ji
GW, Wu YZ, Wang X, Pan HX, Li P,Du WY et al. Experimental and clinical
study of influence of high-frequency electric knives on healing of
abdominal incision. World J Gastroenterol. 2006 Jul 7; 12(25):4082-5.

5. Lawrenson KB, Stephens FO. The use of electrocoagulation

in surgery. Aust NZ J Surg. 1970; 39: 417-21.

6. Kumagai SG, Rosales RF, Hunter GC, RappaportWD, Witzke DB,

Chvapil TA et al. Effects of electrocautery on midline laparotomy wound
infection.Am J Surg1991; 162: 620-2.
7. Pearlman NW, Stiegmann GV, Vance V, Norton LW, Bell RCW, Staerkel R
et al. A prospective study of incisional time, blood loss, pain, and healing
with carbon dioxide laser,scalpel and electrosurgery. Arch Surg1991;
126: 1018-20.

8. Groot G, Chappell W. Electrocautery used to create incisions does not

increase wound infection rates. Am J Surg 1994; 167: 601-3

9. Franchi M, Ghezzi F, Benedetti-Panici PL, Melpignano M, Fallo L, Tateo

S et al. A multicentre collaborative study on the use of cold scalpel
andelectrocautery for midline abdominal incision. Am J Surg 2001; 181:
128-32.

10. Kearns SR, Connolly EM, McNally S, McNamara DA, Deasy J.

Randomized clinical trial of diathermy versus scalpel incision in elective
midline laparotomy. Br J Surg2001 ; 88: 41-4.

11. Chowdri NA, Wani NA, Ganai NA, Naqash SH, Peer GQ, Wani QA.
comparative study of electrosurgical and scalpel incision in general
surgery. IJS 2002; 63: 308-10.

12. Cervantes-Sanchez CR, Cu-ZC, Serrano-Rico E, Rojero-VJ, Lazos-OM,

Gutierrez-VR. Skin Incision: Scalpel vs. Electrocautery. Experimental
study in rats. Rev Med Hosp Gen Mex 2002; 65(1): 11-4.
13. Pollinger HS, Mostafa G, Horold KL, Austin CE, Kercher KW,
Mattews BD. Comparison of wound healing characteristics with
feedback circuit electrosurgical generators in a porcine model. Am J
Surg 2003; 12: 1054-60.

14. Sheikh B. Safety and efficacy of electrocautery scalpel utilization for

skin opening in neurosurgery. Br J Neurosurg. 2004; 18(3): 268-72.

15. Stolz AJ, Schutzner J, Lischke R, Simonek J, Pafko P. Is a scalpel

required to perform a thoracotomy? RozhlChir 2004; 83(4): 185-8.

16. Meka PN, Khullar P, Anand VJ. To compare the superiority of

electrocautery over the traditional scalpel for skin incision. Journal of
surgical research 2004; 121: 341.

17. Chrysos E, Athanasakis E, Antonakakis S, Xynos E, Zoras O. A

prospective study comparing diathermy and scalpel incisions in tension
free inguinal hernioplasty. Am Surg 2005; 71: 326-9.

18. Pollinger HS, Mostafa G, Horold KL, Austin CE, Kercher

KW, Mattews BD. Comparison of wound healing
characteristics with feedback circuit electrosurgical generators in a
porcine model. Am J Surg 2003; 12: 1054-60.

19. Chau JK, Dzigielewski P, Mlynarek A, Cote ow, Allen H, Harris JR et al.
steel scalpel versus electrocautery blade: comparison of cosmetic and
patient satisfaction outcomes of different incision methods. J
Otolaryngol Head Neck Surg 2009; 38: 427-33.

20. Ali Q, Siddique K, Mirza S, Malik AZ. Comparison of superficial

surgical site infection following use of diathermy and scalpel for making
skin incision in inguinal hernioplasty. Niger J ClinPract2009; 12:
371-4.

21. Shamim M. Diathermy vs. scalpel skin incisions in general surgery:

double-blind, randomized, clinical trial. World JSurg2009; 33: 1594-9.

22. Eren T, Balik E, Ziyade S, Yamaner S, Akyuz A, Bugra D. Do different

abdominal incision techniques play a role in wound complications in
patients ope.rated on for gastrointestinal malignancies? 'Scalpel vs
electrocautery' ActaChirBelg201O; 110: 451-6.

23. Ahmad NZ, Ahmed A. Meta-analysis of the effectiveness of surgical

scalpel or diathermy in making abdominal skin incisions. Ann Surg2011;
253: 8-13.

24. Kumar v, Tewari M, Shukla HS. A comparative study of scalpel and

diathermy in head and neck cancer. Indian J Cancer 2011; 48: 216-9.

25. Ly J, Mittal A, Windsor J. Systematic review and meta-analysis of

cutting diathermy versus scalpel for skin incision. Br J Surg. 2012; 99(5) :
613-20.
26. Chalya PL, Mchembe MD, Mabula JB, Gilyoma JM. Diathermy versus
Scalpel incision in elective midline laparotomy: A prospective
randomized controlled clinical study. East and Central Afric J Surg.
2013; 18(1): 71-7.

27. Aird LNF, Bristol SG, Phang PT, Raval MJ, Brown CJ. Randomized
double-blind trial comparing the cosmetic outcome of cutting diathermy
versus scalpel for skin incisions. Br J Surg 2015; 102: 489-94.

28. Talpur AA, Khaskheli AB, Kella N, Jamal A. Randomized, Clinical Trial
on Diathermy and Scalpel Incisions in Elective General Surgery. Iran
Red Cres Med J 2015; 17(2): e14078.
 FACULTY OF MEDICINE & HEALTH SCIENCES

SGT MEDICAL COLLEGE,HOSPITAL AND RESEARCH INSTITUTE

BUDHERA,GURUGRAM-122505,HARYANA

PATIENT INFORMATION SHEET

You are being invited to participate in a research study.

Before you take part in this research study, we wish to explain the study to you and
give you the chance to ask questions. Please read carefully the information provided
here. If you agree to participate, please sign the informed consent form.

STUDY TITLE:- “Randomized control trial comparing the efficacy of diathermy

incision versus scalpel incision in patients undergoing open cholecystectomy.”

PRINCIPAL INVESTIGATOR: Dr. Akhil Kumar Kainth

PURPOSE OF THE RESEARCH STUDY: Our aim is to define which modality

( scalpel or diathermy) used for incision is ideal and has better advantage and lesser
complications compared to the other modality.

STUDY PROCEDURE AND VISIT SCHEDULE: If you agree to participate, both

your Information and history will be recorded on a proforma.

POSSIBLE RISKS/DISCOMFORTS: Following are the possible risks and

discomforts – Burns, bad scars, infection, hematoma, delayed wound healing

POTENTIAL BENEFITS: The results of this study may be of benefit to you and
other patients in future.

SUBJECT’S RIGHTS: You are free not to participate in the study or withdraw from
the study anytime. If you choose not to participate in the study or withdraw from the
study, you will continue to receive the same amount of care and treatment at SGT
Hospital, Gurugram.

CONFIDENTIALITY OF STUDY AND MEDICAL RECORDS: All information

that you provide for the study will be kept confidential.

RESEARCH RELATED INJURIES/COMPENSATION: No injury anticipated.

The hospital does not make any provision to compensate trial subjects for research
related injuries. However, you would be treated for the same at no additional cost at
this hospital. If you have any question, please feel free to ask.
 चचिककित्सस और स्वसस्थ्य ववजसन किक फफैकिल्टट

एसजजीटट ममेडडिकिल किकॉलमेज, अस्पतसल और अननससंधसन ससंस्थसन

बनढमेरस, गनरुगसम-122505 हररयसणस I

ररोगजी ससचिनस पत

आपकिरो एकि शरोध अध्ययन मम भसग लमेनमे किमे ललए आमसंततत ककियस जस रहस हफै ।

इस शरोध अध्ययन मम भसग लमेनमे समे पहलमे, हम आपकिरो अध्ययन किक व्यसख्यस किरनस चिसहतमे हह और आपकिरो प्रश्न
पसछनमे किस ममौकिस दमे तमे हह। किकपयस यहससं दट गई जसनकिसरट ससवधसनजीपसवकि
र्व पढम । अगर आप भसग लमेनमे किमे ललए सहमत हह,
तरो किकपयस सचस चित सहमतत फकॉमर्व पर हस्तसक्षर किरम ।

अध्ययन शजीरर्वकि: - To compare the outcome of diathermy incision versus scalpel incision in patients
undergoing open cholecystectomy

प्रमख
न शरोध किरतस: डिकॉ अखखल किनमसर किससंथ

अन्वमेरकि अध्ययन किस उदमेश्य :- हमसरस लक्ष्य open cholecystectomy समे गनजरनमे वसलमे ररोगजी मम स्किमेलपमेल चिजीरस
versus डिसयदरमजी चिजीरस किक प्रभसवकिसररतस किक तनलनस मम यसदृचचछकि तनयसंतण परटक्षण हफै ।

अध्ययन प्रकक्रियस और अननससचिजी अननससचिजी:-यदद आप भसग लमेनमे किमे ललए सहमत हह, तरो आपकिक जसनकिसरट और
इततहसस दरोनन दजर्व ककिए जसएसंगमे।

ससंभसववत जरोखखम / अस्वजीकिरण:- प्रकक्रियस किक जदटलतस किमे बसरमे मम सभजी प्रसससंचगकि वववरण आपकिरो वववरण मम
समझसए जसएसंगमे, चजसकिमे ललए प्रकक्रियस किमे दमौरसन किरोई जदटलतस हरोनमे पर ससंभसववत उपचिसर प्रदसन ककियस जसएगस।
ससंभसववत लसभ:-इस अध्ययन किमे पररणसम भववष्य मम इसजी तरह किक बजीमसरट वसलमे अन्य ररोचगयन किमे ललए
लसभदसयकि हरो सकितमे हह।

ररोगजी किमे अचधकिसर:-आप अध्ययन मम भसग लमेनमे यस ककिसजी भजी समय अध्ययन समे वसपस लमेनमे किमे ललए स्वतसंत हह। यदद
आप अध्ययन मम भसग नहटसं लमेनमे यस अध्ययन समे नसम वसपस लमेनमे किस चियन किरतमे हह, तरो आपकिरो एसजजीटट
अस्पतसल, गनरुगसम मम उचचित दमे खभसल और उपचिसर प्रसप्त हरोगस ।

अध्ययन और चचिककित्सस ररकिकॉडिर्व किक गरोपनजीयतस:-अध्ययन किमे ललए जरो जसनकिसरट आप प्रदसन किरतमे हह उसमे गरोपनजीय
रखस जसएगस।

शरोध ससंबसंचधत चिरोट / क्षतत:-किरोई चिरोट किक उम्मजीद नहटसं हफै ।

अस्पतसल शरोध ससंबसंधजी चिरोटन किमे ललए परटक्षण ववरयन किक क्षततपसततर्व किरनमे किमे ललए किरोई प्रसवधसन नहटसं किरतस हफै ।
हसलससंककि, इस अस्पतसल मम आपकिरो अततररक्त लसगत किमे तबनस उसकिस इलसज ककियस जसएगस।

आपकिस किरोई सवसल हफै , तरो किकपयस बमेखझझकि पसछम।

 
 INFORMED CONSENT FORM
Date:

I, Mr,Mrs____________________________________, Age___________ Years residing at

_____________________________________________________________________________

Diagnosis_____________________________________________________________________

Operation planned______________________________________________________________

Hereby give my informed consent to participate in the__________________________________

project.

There is no compulsion on me to participate in this project and I am giving my free consent for it.

 I am ready and willing to undergo all tests and treatment in the present project .

 I have read and I have been explained the general information and purpose of present project

 I have been informed/ I have read the probable complications that I may suffer while participating in the
present project.

 I know that I can withdraw from the present project at any time.

 Any data analysis of this project will be properly used for scientific purposes and my name will be
kept confidential except when required for any legal purpose.

 I can read English and can understand data read out to me in English.

Left thumb impression / signature of patient Left thumb impression/signature of parents

Signature of patient’s Relative guardians/NOK of minor

WITNESSES:

1. Doctor incharge of the ward:

2. Nurse incharge of the ward:

Date: SIGNATURE OF INVESTIGATOR

Place :SGT MEDICAL COLLEGE NAME :

Budhera, Gurugram,122505, Haryana India

 सचस चित सहमतत पत

1) मह, शजीमसन/ शजीमतजी____________________________________, आयन___________

__________________________________________________ पर रहनमे वसलमे वरर्व

2) तनदसन__________________________________________________________________ इस
प्रकिसर ममेरट ससचचित सहमतत
किरो________________________________________________________________________________
______________________________ शरोध मम भसग लमेनमे किमे ललए दम ।

3) ऑपरमे शनयरोजनसबद____________________________________________ इस प्रकिसर ममेरट सचस चित

सहमतत किरो________________________________________________ शरोध मम भसग लमेनमे किमे ललए दमे तस/
दमे तजी हससं।

4) इस शरोध मम भसग लमेनमे किमे ललए मनझ पर किरोई बसध्यतस नहटसं हफै और मह इसकिमे ललए अपनजी स्वतसंत सहमतत
दमे रहस हससं।

5) मह वतर्वमसन शरोध मम सभजी परटक्षणन और उपचिसर समे गनजरनमे किमे ललए तफैयसर हससं और तफैयसर हससं ।

6) महनमे पढस हफै और मनझमे वतर्वमसन शरोध किक ससमसन्य जसनकिसरट और उदमेश्य किक व्यसख्यस किर दट गई हफै

7) मनझमे ससचचित ककियस गयस हफै और महनमे वतर्वमसन पररयरोजनस मम भसग लमेनमे किमे दमौरसन

ससंभसववत जदटलतसओसं किक ससंभसवनसओसं किमे बसरमे मम पढस हमे हफै ।

8) मनझमे पतस हफै ककि मह ककिसजी भजी समय वतर्वमसन पररयरोजनस समे वसपस लमे सकितस हससं।

9) इस पररयरोजनस किस किरोई भजी डिमेटस ववश्लमेरण वफैजसतनकि उदमेश्यन किमे ललए उचचित रूप समे उपयरोग ककियस जसएगस
और ककिसजी भजी किसनसनजी उदमेश्य किमे ललए आवश्यकि हरोनमे किमे बसवजसद ममेरस नसम गरोपनजीय रखस जसएगस।

10) मह दहसंदट पढ सकितस हससं और दहसंदट मम मझ

न मे पढनमे वसलमे डिमेटस किरो समझ सकितस हससं।
मरटज किमे बसएसं /दसयससं असंगसठमे किस तनशसन/ मरटज किमे बसएसं /दसयससं असंगसठमे किस तनशसन

हस्तसक्षर (मरटज किमे ससंबसंचधयन) किमे हस्तसक्षर

गवसहन:

1. वसडिर्व किमे डिकॉक्टर प्रभसरट : ………………………………………………………

2. वसडिर्व किमे नसर्व प्रभसरट : …………………………………………………………..

शरोधकितसर्व किमे हस्तसक्षर

तसरटख : (नसम : डिकॉ अखखल किनमसर किससंथ)

जगह : 8126572851

 
 STUDY PROFORMA

Group :

Patient detail:

Patient’s name:

Age/ Sex :

I.P.D number :

Chief complaints :

General examination :

Pulse rate:

Blood pressure:

Respiratory rate:

Systemic examination :

Abdomen:

34
Investigations:

Blood:

Urine:

USG:

CECT:

MRI:

Final diagnosis :

Operative procedure:

Anesthesia:

35
Operative notes :

Incision made with :

Incision time:

Incision length:

Amount of blood loss:

Evaluation of postoperative complications:

Seroma/ Hematoma/ Purulent discharge

Suture line at 8th postoperative day -

Suture line at 14th postoperative day -

Suture line at 30th postoperative day -

Suture line at 90th postoperative day -

Suture line at 180th postoperative day -

36
37