To compare different methods of doing laparoscopic cholecystectomy i.e. with four holes or single hole

Recruiting

• Conditions: ASA 1/2 pateints with gall stone disease

• Registration Number: CTRI/2012/11/003126
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

**Introduction**

Cholecystectomyis one of the most common procedures done today for symptomatic as well asasymptomatic gall stone disease. Since the time Eric Muhe performed firstlaproscopic cholecystectomy (LC) in 19851 it has become the goldstandard for gall stone disease. But the quest for better cosmesis and demandfor scarless surgery continued and this led to development of NOTES (naturalorifice transluminal endoscopic surgery) and single-incision laparoscopicsurgery. The single-incision laparoscopic technique allows many abdominalprocedures suited to conventional three- or four-port laparoscopic surgery tobe performed through a single incision, utilising a specialised multi-channelaccess port. Potential benefits to patients following a single-incisionlaparoscopic procedure include the possibility of no visible scarring, theelimination of pain from multiple sites of entry and a faster recovery timecompared with open surgery. Various ports and instruments and various surgicalmethods used in performing SILC are available in many institutions, however, itis necessary to standardize an excellent procedure that can be performed safelyand easily like the conventional 4-port LC, and it is also necessary to balancesafety, operability, and economy in this new technique by comparing outcome, acuteand chronic pain, quality of life and cosmetic outcome with standard 4 port laparoscopiccholecystectomy. There are few studies in the literature comparing these twotechniques but in most of the studies were not executed properly and resultswere equivocal. This study has been planned to compare standard LC with SILC interms of outcome, safety, cosmetic results, patient satisfaction, postoperativepain and quality of life.

**Materials and Methods**

Thisstudy will be carried out in the Department of Surgical Disciples, All IndiaInstitute of Medical Sciences, NewDelhi,  after clearance from ethical committee. All consecutive patients undergoingsurgery for gallstones in one surgical unit will be considered and only thosepatients who give written consent for both the procedures will be randomized.Randomization will be done using computer generated random numbers. These willbe divided into blocks of eight using sealed envelopes to ensure concealedallocation. The patients will be randomized in to 2 groups, Group 1- StandardFour Port Laparoscopic Cholecystectomy, Group 2- Single Incision Laparoscopic Cholecystectomy

The sample size was calculated based on comparison ofoperative time and early cosmetic outcomes in previous studies. Assuming thatcomplications in two modalities are same and minimal blood loss, the meancosmetic outcome and operative time is 41.3 in SILC and 35.6 in standard 4 portwith 1:1, alpha value 5% and power 80% we need to enrol 43 patients in eachgroup that is total 86 cases. Further since it is a prospective study assumingthat 10% dropouts are there so it was decided to enrol 100 patients 50 in eachmodality.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-09
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All consecutive patients with gall stone disease.

Exclusion Criteria

• 1.Patients who do not give consent for participation in the study.
• 2.Patients with morbid obesity.
• 3.Patients unfit for GA.
• 4.Patient with uncorrectable coagualopathy 5.Patient with significant co-morbidities like coronary artery disease, asthma, COPD, DM and previous malignancy.
• 6.Patients requiring other concomitant procedures.
• 7.Chronic analgesic use.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the outcome of two modalities of treatment of gall stone disease i.e. standard four port laparoscopic cholecystectomy and single incision laparoscopic cholecystectomy in terms of success, pain, quality of life and cosmesis.	Patients will be assessed 24hrs after surgery or at time of discharge whichever is earlier. Follow up at 1 week , 6 weeks, 3months, 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Complications, post operative hospital stay and cost effectiveness	Postoperative one week to 1 month

Trial Locations

Locations (1)

All India Institute of Medical Sciences, New Delhi, India; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences, New Delhi, India

🇮🇳South, DELHI, India

Virinder Kumar Bansal

Principal investigator

01126593686

drvkbansal@gmail.com