CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 202 enrolled
Drug / intervention
SILS™ port 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/NCT00832767
NCT00832767N/ACompleted
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Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy

Medtronic - MITG·interventional·Posted Jan 30, 2009·Updated Dec 18, 2017

In Brief

A clinical study evaluating SILS™ port laparoscopic cholecystectomy and Four Port Laparoscopic Cholecystectomy for Gallbladder Disease. Completed, enrolled 202 participants across 10 sites in 3 countries.

Detailed Summary

The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGallbladder Disease
CountriesItaly, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 30, 2009
Enrollment StartApr 1, 2009
Primary CompletionSep 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.4 years ago

Interventions

SILS™ port laparoscopic cholecystectomyprocedure

This interventional arm will have a single incision laparoscopic cholecystectomy procedure.

Four Port Laparoscopic Cholecystectomyprocedure

This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.