CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 115 enrolled
Drug / intervention
Laparoscopic cholecystectomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01397565
NCT01397565Phase 4Completed

Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy: A Randomized Trial

In Brief

A Phase 4 clinical trial evaluating Laparoscopic cholecystectomy and Minilaparoscopic cholecystectomy for Cholelithiasis and Cholecystectomy. Completed, enrolled 115 participants across 1 site.

Detailed Summary

Laparoscopic cholecystectomy is one of the most commonly performed operations in general surgery and is considered the standard of care for cholecystectomy for benign biliary disease. The laparoscopic approach to cholecystectomy, when compared to open surgery, is associated with less postoperative pain, quicker recovery time and an improved cosmetic result. Most commonly, laparoscopic cholecystectomy is performed using a 10-12mm port in the umbilicus with 3 additional ports consisting of either three 5mm ports, or a combination of two 5mm ports and one 10mm port. A new technique called minilaparoscopic (also referred to as needlescopic) surgery has recently emerged. Minilaparoscopic surgery replaces 5mm trocars with smaller 3mm trocars. Surgery using these smaller trocars is hypothesized to further reduce postoperative pain and recovery time as well as improve cosmetic results following laparoscopic surgery. Our goal is to compare these outcomes in a randomized trial comparing conventional to minilaparoscopic cholecystectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2011
Enrollment StartFeb 1, 2012
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.0 years ago

Interventions

Laparoscopic cholecystectomyprocedure

Laparoscopic cholecystectomy

Minilaparoscopic cholecystectomyprocedure

Laparoscopic cholecystectomy performed using minilaparoscopic instruments