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Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

Primary Purpose

Cholelithiasis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Single trocar cholecystectomy
Standard laparoscopic cholecystectomy
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring cholelithiasis, cholecystitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hadassah Medical Organization Ein-Kerem campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single trocar

Standard lap cholecystectomy

Arm Description

Patients will undergo cholecystectomy by the single trocar approach

Standard lap choly

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess pain associated with the single trocar approach
To assess scar formation associated with single trocar approach

Full Information

First Posted
August 3, 2008
Last Updated
July 28, 2020
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00732550
Brief Title
Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
Official Title
Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
cholelithiasis, cholecystitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single trocar
Arm Type
Experimental
Arm Description
Patients will undergo cholecystectomy by the single trocar approach
Arm Title
Standard lap cholecystectomy
Arm Type
Active Comparator
Arm Description
Standard lap choly
Intervention Type
Procedure
Intervention Name(s)
Single trocar cholecystectomy
Intervention Description
Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach
Intervention Type
Procedure
Intervention Name(s)
Standard laparoscopic cholecystectomy
Intervention Description
Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.
Time Frame
Continuous
Secondary Outcome Measure Information:
Title
To assess pain associated with the single trocar approach
Time Frame
Continuous
Title
To assess scar formation associated with single trocar approach
Time Frame
Continuous

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoav Mintz, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Avraham Rivkind, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Chair
Facility Information:
Facility Name
Hadassah Medical Organization Ein-Kerem campus
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

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