Introduction

Cholecystectomy is one of the most common procedures done today for symptomatic as well as asymptomatic gall stone disease. Since the time Eric Muhe performed first laproscopic cholecystectomy (LC) in 1985¹ it has become the gold standard for gall stone disease. But the quest for better cosmesis and demand for scarless surgery continued and this led to development of NOTES (natural orifice transluminal endoscopic surgery) and single-incision laparoscopic surgery. The single-incision laparoscopic technique allows many abdominal procedures suited to conventional three- or four-port laparoscopic surgery to be performed through a single incision, utilising a specialised multi-channel access port. Potential benefits to patients following a single-incision laparoscopic procedure include the possibility of no visible scarring, the elimination of pain from multiple sites of entry and a faster recovery time compared with open surgery. Various ports and instruments and various surgical methods used in performing SILC are available in many institutions, however, it is necessary to standardize an excellent procedure that can be performed safely and easily like the conventional 4-port LC, and it is also necessary to balance safety, operability, and economy in this new technique by comparing outcome, acute and chronic pain, quality of life and cosmetic outcome with standard 4 port laparoscopic cholecystectomy. There are few studies in the literature comparing these two techniques but in most of the studies were not executed properly and results were equivocal. This study has been planned to compare standard LC with SILC in terms of outcome, safety, cosmetic results, patient satisfaction, postoperative pain and quality of life.

Materials and Methods

This study will be carried out in the Department of Surgical Disciples, All India Institute of Medical Sciences, NewDelhi,  after clearance from ethical committee. All consecutive patients undergoing surgery for gallstones in one surgical unit will be considered and only those patients who give written consent for both the procedures will be randomized. Randomization will be done using computer generated random numbers. These will be divided into blocks of eight using sealed envelopes to ensure concealed allocation. The patients will be randomized in to 2 groups, Group 1- Standard Four Port Laparoscopic Cholecystectomy, Group 2- Single Incision Laparoscopic Cholecystectomy

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