Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Cholelithiasis
• Interventions: Procedure: Standard laparoscopic cholecystectomy; Procedure: Single trocar cholecystectomy

• Registration Number: NCT00732550
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-03
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Status Verified: 2016-04
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 18-60
• symptomatic cholelithiasis
• ASA 1-2

Exclusion Criteria

• pregnancy
• morbid obesity with BMI>35
• other gallbladder pathology like polyps or tumor
• history of upper abdomen laparotomy
• suspected choledocholithiasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard lap cholecystectomy	Standard laparoscopic cholecystectomy	Standard lap choly
Single trocar	Single trocar cholecystectomy	Patients will undergo cholecystectomy by the single trocar approach

Primary Outcome Measures

Name	Time	Method
To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.	Continuous

Secondary Outcome Measures

Name	Time	Method
To assess pain associated with the single trocar approach	Continuous
To assess scar formation associated with single trocar approach	Continuous

Trial Locations

Locations (1)

Hadassah Medical Organization Ein-Kerem campus; 🇮🇱 Jerusalem, Israel