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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01824186

Enrollment

100

Registered

2013-04-04

Start date

2010-10-31

Completion date

2012-10-31

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis, Choledocholithiasis, Cholecystolithiasis, Pancreatitis, Cholangitis

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

Interventions

PROCEDURESILC

Underwent single-incision laparoscopic cholecystectomy

PROCEDURELC

Underwent conventional 4-port laparoscopic cholecystectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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 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 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 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

Measure	Time frame	Description
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026