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

A Randomized Controlled Trial Comparing Post-operative Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis; Cholangitis; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis
• Intervention / Treatment: Procedure: SILC; Procedure: LC

Detailed Description

As above

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SILC; Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision	Procedure: SILC; Underwent single-incision laparoscopic cholecystectomy; Other Names: Single-incision laparoscopic cholecystectomy
Active Comparator: LC; Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank	Procedure: LC; Underwent conventional 4-port laparoscopic cholecystectomy; Other Names: Conventional laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain 4 hours	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.	4 hours post-operative
Post-operative pain 24 hours	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.	24 hours post-operative
Post-operative pain 14 days	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.	14 days post-operative
Post-operative pain 6 months	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.	6 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural complications	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	6 months
Operative duration	To evaluate operative duration between single-incision laparoscopic cholecystectomy vs the conventional four port technique	following skin closure
Subject satisfaction	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)	14 days and 6 months
Return to function	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	14 days

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Investigators: Principal Investigator: Stephen Kin Yong Chang, FRCS, National University Hospital, Singapore

Publications and helpful links

General Publications

• Chang SK, Wang YL, Shen L, Iyer SG, Madhavan K. A randomized controlled trial comparing post-operative pain in single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy. World J Surg. 2015 Apr;39(4):897-904. doi: 10.1007/s00268-014-2903-6.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: March 21, 2013
• First Submitted That Met QC Criteria: March 31, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: March 31, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Calculi; Pancreatitis; Cholangitis; Gallstones; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis
• Other Study ID Numbers: NHG DSRB 2009/00434