Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01195285

Enrollment

Registered

2010-09-06

Start date

2010-02-28

Completion date

2012-01-31

Last updated

2012-04-30

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

Conditions

Biliary Dyskinesia, Cholecystitis, Cholelithiasis, Gallstones

Keywords

Laparoscopic cholecystectomy, Quality of life, Biliary Cholic, Chronic Cholecystitis, Symptomatic Cholelithiasis

Brief summary

This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.

Detailed description

Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.

Interventions

PROCEDURESingle-Incision Laparoscopic Surgery cholecystectomy

Laparoscopic Cholecystectomy

PROCEDURETraditional Laparoscopic Cholecystectomy (TLC)

Laparoscopic Cholecystectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patient recommended to undergo cholecystectomy * Patient age 18-80 * Patient competent to give his/her own informed consent * Patient speaks English without the need for an interpreter

Exclusion criteria

* Additional procedures planned during same surgery * Patient deemed inappropriate for TLC or SILS cholecystectomy

Design outcomes

Primary

Measure	Time frame
Cost associated with performance of the procedure and post-operative care until discharge	4 weeks

Secondary

Measure	Time frame
Pain scale reported by patient at discharge, 24 and 48 hours	24 hours and 48 hours
Amount of pain medicine required during 48 hours after surgery	48 hours
Major and minor gastrointestinal surgical complications, including conversion	4 weeks
Quality of Life	2 weeks and 4 weeks

Countries

United States

Outcome results

None listed

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