This trial is active, not recruiting.

Condition cholelithiasis
Treatments single trocar cholecystectomy, standard laparoscopic cholecystectomy
Sponsor Hadassah Medical Organization
Start date July 2008
End date September 2015
Trial size 20 participants
Trial identifier NCT00732550, Single trocar HMO-CTIL


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Patients will undergo cholecystectomy by the single trocar approach
single trocar cholecystectomy
Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach
(Active Comparator)
Standard lap choly
standard laparoscopic cholecystectomy
Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy

Primary Outcomes

To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.
time frame: Continuous

Secondary Outcomes

To assess pain associated with the single trocar approach
time frame: Continuous
To assess scar formation associated with single trocar approach
time frame: Continuous

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
Principal investigator Yoav Mintz, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Hadassah Medical Organization.