A Comparative Studybetween Open And

A COMPARATIVE STUDYBETWEEN OPEN AND

LAPAROSCOPIC CHOLECYSTECTOMY

SYNOPSIS OF THE DISSERTATION SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE,

BANGALORE, KARNATAKA

IN PARTIAL FULFILLMENT OF THE REGULATIONS FOR THE AWARD OF

MASTER OF SURGERY IN GENERAL SURGERY

SUBMITTED

Dr. ANMOL. N

P.G. DEPARTMENT OF GENERAL SURGERY

UNDER THE GUIDANCE OF

Dr. LAKSHMINARAYAN. G

PROFESSOR OF GENERAL SURGERY

SAH & RC.AIMS.B.G.NAGARA

ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES

B.G.NAGARA

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS OF DISSERTATION

Sl. No. / Title / Details
01. / Name Of The Candidate / Dr. ANMOL. N
02. / Designation / Post Graduate in General Surgery
03. / Address / Room No. 86,
Kalpataru Bhavan,
A.I.M.S.,
B.G.Nagara, Nagamangala Taluk,
Mandya District,
Karnataka - 571448.
04. / Name Of The Institution / Sri Adichunchanagiri Institute Of Medical Sciences,
B.G.Nagara, Nagamangala Taluk,
Mandya District,
Karnataka - 571448.
05. / Course Of The Study &
Subject / Post Graduation In Master of Surgery
In General Surgery
06. / Date Of Admission To Course / 31st May 2010
07. / Title Of The Topic / “A Comparative study between Open and Laparoscopic Cholecystectomy”
08. / Brief Resume Of The Intended Work
8.1Need for the Study
8.2Review of the Literature
8.3Objectives of the Study / VIDE APPENDIX – I
Appendix - IA
Appendix - IB
Appendix – IC
09. / Materials And Methods
9.1Source of Data
9.2Method of Collection of Data-Including Sampling Procedure if any
9.3Does the Study Require any Investigations or Interventions to be Conducted on Patients or Other Animals; if so Please Describe Briefly
9.4Has Ethical Clearance been Obtained from your Institution for the Above / VIDE APPENDIX – II
Appendix - IIA
Appendix - IIB
Appendix - IIC
Appendix – IID
10. / List of References / VIDE APPENDIX – III
11. / Signature Of The Candidate
12. / Remarks Of The Guide / The proposed study is being done to determine the efficacy of either laparoscopic or open cholecystectomy in terms of reducing operative complications and post-operative morbidity and perhaps will throw more light on the advantages and disadvantages of either.
13. / Name Of Guide
Designation Of Guide
Signature Of Guide / Prof. Dr. LAKSHMINARAYAN. G, MBBS,MS
Professor and Unit Chief,
Department Of General Surgery,
A.I.M.S, B.G.Nagara.
14. / Co-Guide (If Any)
Designation
Signature / No
-NA-
-NA-
15. / Head Of The Department
Signature / Prof. Dr. R. SRINATH, MBBS, MS
Professor & H.O.D.,
Department Of General Surgery,
A.I.M.S, B.G.Nagara.
16. / Remarks Of The Chairman & Principal
Signature / The facilities required for the investigation will be made available by the college.
Dr. S. B. VASANTHKUMAR,
MSc, MS, FICS, FIAGES
Principal and Medical Superintendent
A.I.M.S, B.G.Nagara.

APPENDIX-I

8.0 BRIEF RESUME OF THE INTENDED WORK

APPENDIX-1A

8.1 NEED FOR THE STUDY

Gastro-intestinal surgery has undergone a revolution in the recent years by the

introduction of laparoscopic techniques.

Cholelithiasis, which continues to be one of the most common digestive disorders encountered, was traditionally being dealt by conventional(open) cholecystectomy. With the introduction of laparoscopic cholecystectomy, the surgical community witnessed a revolution in post-operative recovery of the patient.

Laparoscopic cholecystectomy (LC) is safe and easy, which can be performed with much ease and safety because of the better magnification.

LC has shown clear benefits in terms of shortened hospital stay, less morbidity, a quicker return to work and with cosmetic advantage.

Some surgeons have suggested that the rates of serious complications, particularly bile duct injury might be significantly higher in laparoscopic procedure.

The high costs of the laparoscopic equipment and the specialized training that is mandatory for mastery of the technique, the procedure inherently carries hazards and risks.

Could laparoscopic cholecystectomy establish itself as a safe and cost effective alternative to the open method?

In our study, we have planned an attempt to compare the advantages and drawbacks of both the procedures.

APPENDIX-IB

8.2 REVIEW OF LITERATURE

Gall stones and their sequel which cause most of the maladies date back to 1085-945 BC having been discovered in the mummy of Priestess of Amen.1

The first cholecystectomy is credited to John Strong Bobbs1 on June 15, 1867.
Karl Langenbuch of Berlin performed first planned cholecystectomy on July 15, 1882 using the aseptic technique of Joseph Lister2.
The first ever laparoscopic cholecystectomy was performed by Philip Mourret2 in Lyon in 1987 and Dubois performed it in Paris in 1988.
In 1991, Tehemton Udwadia performed the first laparoscopic cholecystectomy in India.

Grace et al3compared 50 consecutive patients who underwent laparoscopic

cholecystectomy with those of a group of 25 patients who underwent open

cholecystectomy during 3 months before introduction of laparoscopic cholecystectomy.

When compared with laparotomy, laparoscopic cholecystectomy was associated with

longer mean (s.d) anaesthesia, 155(61) min versus 102(31) min (p<0.001), shorter mean

post operative stay, 3.5(1.5) versus 8.8 (3.2) days (p<0.001) and reduced mean cost.

Williams Jr. et al4conducted a retrospective study between 1,283 open cholecystectomies and 1,107 laparoscopic cholecystectomies and found that there was a higher mortality rate in the patients with acute cholecystitis treated with (OC) Open cholecystectomy (2.3% versus 0%, p=0.03) and an increase in the overall complications in the patients with chronic cholecystitis in the OC group (7.5% versus 3.1%, p<0.001) compared with the LC group which was primarily related to the increased rate of wound related complications (3.6% versus 0%, p<0.001).

Bosch5compared clinical aspects and financial costs of 153 OC and 22 LC and found that operating time was 66 and 92 minutes, complications 9 and 6 cases, post operative stay 8 and 3 days and total cost of hospital US$3434 and 2808 respectively. He concluded that the cost of LC was 18% less than for OC principally because of the shorter post operative stay.

Johansson et al6in a randomized clinical trial of OC v/s LC for acute cholecystitis studied the impact of surgical approach on morbidity and post operative recovery. 70 patients were randomized in 2 groups and were similar with respect to clinical and demographic characteristics. There was no significant difference in the rate of post operative complications, pain score at discharge and sick leave. 8 patients required conversion. Median operating time was 90(30-155 min) and 80(50-170min) in LC and OC groups respectively (p=0.04). The direct medical costs were equivalent in the 2 groups. The post operative hospital stay was significantly shorter in the LC group (p=0.011).

APPENDIX-IC

8.3 AIMS AND OBJECTIVES OF THE STUDY

The aim of this study is to compare conventional cholecystectomy and

laparoscopic cholecystectomy with respect to:-

1. Duration of the procedure.

2. Post operative recovery.

3. Analgesic requirement.

4. Complications encountered.

5. Period of hospitalization.

6. Patient satisfaction.

APPENDIX-II

9. MATERIAL AND METHODS

APPENDIX-IIA

9.1 SOURCE OF DATA

This study is conducted in the Department of General Surgery at

Sri Adichunchanagiri Hospital and Research Centre, B.G.Nagara, Mandya district.

Sample size of a minimum of 50 patients fulfilling the inclusion criteria will be a part of this study conducted for a duration of 18months.

Study design: Comparative randomized study.

Method of randomization:Randomization will be done using SAS software.

APPENDIX-IIB

9.2 METHODS OF COLLECTION OF DATA

Data will be collected from patients who are admitted in surgical wards of

SAH & RC, with a provisional diagnosis of cholecystitis.

Clinical study will be through questionnaires and clinical examination.

All patients will undergo routine and special investigations

Treatment modality will be planned once the definitive diagnosis of cholecystitis is arrived at.

Post operative observation of patients for any complications.

Regular follow up and health education for the patients treated.

INCLUSION CRITERIA OF STUDY GROUP

Patients with cholelithiasis proven by USG with at least one attack of

upper abdominal pain and considered fit for elective cholecystectomy were included in the study.

EXCLUSION CRITERIA OF STUDY GROUP

The patients with following conditions were excluded from the study:

• History or investigations suggesting CBD stones.

• History of prior abdominal surgery.

• Patient’s age above 70 years.

Patients of coagulopathy and those on Anti-Coagulant therapy.

APPENDIX-IIC

9.3Does the study require any investigations or interventions to be

conducted on patients and other animals? If so describe briefly

Yes

INVESTIGATIONS :

Routine investigations:

Haemoglobin percentage

Total count

Differential count

Erythrocyte sedimentation rate

Bleeding time

Clotting time

Urine for protein, sugar and microscopy

Random blood sugar

Blood urea

Serum creatinine

Serum electrolytes

HIV/ HBsAG

Blood grouping

Chest radiograph

Electrocardiogram

Specific investigations:

Ultrasound abdomen and pelvis

Liver function test

PT, aPTT, INR

CT Scan

INTERVENTION :

Conventional Cholecystectomy.

Laparoscopic Cholecystectomy.

APPENDIX-IID

9.4 Proforma Application for Ethics Committee Approval

SECTION A
01. / Title Of The Study / “A Comparative Study between Open and
Laparoscopic Cholecystectomy”
02. / Principle Investigator
(Name & Designation) / Dr. ANMOL.N
P.G In General Surgery
03. / Co-Investigator
(Name & Designation) / Prof. Dr. LAKSMINARAYAN. G,MBBS, MS
Professor and Unit Chief
Department Of General Surgery,
A.I.M.S., B.G.Nagara
04. / Name Of The Collaborating Department/Institution / Department Of General Surgery,
A.I.M.S., B.G.Nagara
05. / Whether Permission Has Been Obtained From The Head Of The Collaborating Departments & Institution. / Yes
SECTION B
Summary Of The Project / APPENDIX – I
SECTION C
Objectives Of The Study / APPENDIX – IC
SECTION D
Methodology / APPENDIX – IIB
01. / Where The Proposed Study Will Be Undertaken / SAH & RC, B.G.Nagara
02. / Duration Of The Project / 18 months
03. / Nature Of The Subjects:

Does The Study Involve Adult Patients?
Does The Study Involve Children?
Does The Study Involve Normal Volunteers?
Does The Study Involve Psychiatric Patients?
Does The Study Involve Pregnant Women?

/ Yes
No
No
No
No
04. / If The Study Involves Health Volunteers

Will They Be Institute Students?
Will They Be Institute Employees?
Will They Be Paid?
If They Are To Be Paid, How Much Per Session

/ No
-NA-
-NA-
-NA-
-NA-
05. / Is The Study Part Of Multi Central Trial?
If Yes, Who Is The Coordinator?
(Name & Designation)
Has The Trial Been Approved By The Ethics Committee Of Other Centers? / No
-NA-
-NA-
06. / If The Study Involves The Use Of Drugs:
Please Indicate Whether,

The Drug Is Marketed In India For The Indication In Which It Will Be Used In The Study.
The Drug Is Marketed In India But Not For The Indication In Which It Will Be Used In The Study.
The Drug Is Only Used For Experimental Use In Humans.
Clearance Of The Drug Controller Of India Has Been Obtained For:

Use of the Drug in Patients for a New Indication.
Phase One & Two Clinical Trials.
Experimental Use in Patients & Health Volunteers.

/ No
-NA-
-NA-
-NA-
-NA-
-NA-
07. / How Do You Propose To Obtain The Drug To Be Used In The Study?

Gift From A Drug Company
Hospital Supplies
Patients Will Be Asked To Purchase
Other Sources (Explain)

/ -NA-
08. / Funding (If Any) For The Project Please State

None
Amount
Source

To Whom Payable

/ -NA-
09. / Does Any Agency Have A Vested Interest In The Outcome Of The Project? / No
10. / Will Data Relating To Subjects/Controls Be Stored In Computer? / No
11. / Will The Data Analysis Be Done By

The Researcher?
The Funding Agent?

/ Yes
No
12. / Will Technical/Nursing Help Be Required From The Staff Of The Hospital?
If Yes, Will It Interfere With Their Duties?
Will You Recruit Other Staff For The Duration Of The Study?
If Yes, Give Details Of

Designation
Qualification
Number
Duration Of Employment

/ No
-NA-
No
-NA-
13. / Will Informed Consent Be Taken?
If Yes,

Will It Be Written Informed Consent?
Will It Be Oral Consent?
Will It Be Taken From The Subject Themselves?
Will It Be From The Legal Guardian?

/ No
-NA-
-NA-
-NA-
-NA-
14. / Describe Design, Methodology & Techniques / APPENDIX – II

Please note: NA = not applicable.

Ethical Clearance Has Been Accorded

Date: Chairman

P.G. Training-Cum Research Committee

A.I.M.S., B.G.Nagara.

APPENDIX-III

LIST OF REFERENCES:

1. Glenn F, Grafe WR Jr. Historical Events in Biliary Tract Surgery. Arch Surg

1966Nov; 93: 848-52.

2. Beal JM. Historical perspective of gallstone disease. Surgery, Gynecology &

Obstetrics1984; 158: 181 – 188.

3. Grace PA, Quereshi A, Coleman J, Keane R, McEntee G, Broe P et al. Reduced

postoperative hospitalization after laparoscopic cholecystectomy. Br J Surg 1991Feb;

78: 160-62.

4. Lester F Williams Jr., Chapman WC, Bonau RA, McGee EC Jr., Boyd RW, Jacobs JK.

Comparison of laparoscopic with open cholecystectomy in a single Center. AJS 1993;

165:459-65.

5.Bosch F, Wehrman U, Saeger HD, Kirch W. Laparoscopic or open conventional

cholecystectomy: clinical and economic considerations. Eur J Surg 2002;

168(5): 270-7.

6. Johansson M, Thune A, Nelvin L, Stiernstam M, Westman B, Lundell L. Randomized clinical trial of open versus laparoscopic cholecystectomy for acute cholecystitis. Br J Surg 2005; 92: 44-49.