Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

Cholelithiasis Clinical Trial

Official title:

Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732550
• Other study ID #: Single trocar HMO-CTIL
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: September 2018

Study information

• Verified date: April 2016
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Single trocar cholecystectomy
Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach
• Standard laparoscopic cholecystectomy
Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization Ein-Kerem campus	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.		Continuous
Secondary	To assess pain associated with the single trocar approach		Continuous
Secondary	To assess scar formation associated with single trocar approach		Continuous