Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Cholecystolithiasis; Pancreatitis; Choledocholithiasis; Cholangitis; Cholelithiasis
• Interventions: Procedure: SILC; Procedure: LC

• Registration Number: NCT01824186
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain.

Detailed Description

As above

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-03
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-31
• Last Update Submitted: 2013-03-31
• Study First Posted: 2013-04-04
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• presence of symptomatic gallstones
• American Society of Anesthesiologists (ASA) score 1 or 2
• informed consent

Exclusion Criteria

• active acute cholecystitis
• previous open upper abdominal surgery
• bleeding disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SILC	SILC	Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision
LC	LC	Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank

Primary Outcome Measures

Name	Time	Method
Post-operative pain 6 months	6 months post-operative	To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Post-operative pain 24 hours	24 hours post-operative	To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Post-operative pain 4 hours	4 hours post-operative	To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Post-operative pain 14 days	14 days post-operative	To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.

Secondary Outcome Measures

Name	Time	Method
Procedural complications	6 months	To evaluate complications between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Conducted via telephone interview and review of hospital records in the intervening period
Operative duration	following skin closure	To evaluate operative duration between single-incision laparoscopic cholecystectomy vs the conventional four port technique
Subject satisfaction	14 days and 6 months	To evaluate subject satisfaction between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Measured on a Likert scale, from 1-5 (1 least satisfied, 5 most satisfied)
Return to function	14 days	To evaluate post-operative return to function following surgery, between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Measured as days taken to independent toileting, and independently obtaining meals as a surrogate measure of function

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore