Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
July 28, 2020 updated by: Hadassah Medical Organization
The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jerusalem, Israel
- Hadassah Medical Organization Ein-Kerem campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single trocar
Patients will undergo cholecystectomy by the single trocar approach
|
Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach
|
|
Active Comparator: Standard lap cholecystectomy
Standard lap choly
|
Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.
Time Frame: Continuous
|
Continuous
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess pain associated with the single trocar approach
Time Frame: Continuous
|
Continuous
|
|
To assess scar formation associated with single trocar approach
Time Frame: Continuous
|
Continuous
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yoav Mintz, MD, Hadassah Medical Organization
- Study Chair: Avraham Rivkind, MD, Hadassah Medical Organization
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
August 3, 2008
First Submitted That Met QC Criteria
August 11, 2008
First Posted (Estimate)
August 12, 2008
Study Record Updates
Last Update Posted (Actual)
July 30, 2020
Last Update Submitted That Met QC Criteria
July 28, 2020
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Single trocar HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.