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Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hadassah Medical Organization Identifier:
First received: August 3, 2008
Last updated: April 13, 2016
Last verified: April 2016
The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.

Condition Intervention
Procedure: Single trocar cholecystectomy
Procedure: Standard laparoscopic cholecystectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques. [ Time Frame: Continuous ]

Secondary Outcome Measures:
  • To assess pain associated with the single trocar approach [ Time Frame: Continuous ]
  • To assess scar formation associated with single trocar approach [ Time Frame: Continuous ]

Estimated Enrollment: 20
Study Start Date: July 2008
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single trocar
Patients will undergo cholecystectomy by the single trocar approach
Procedure: Single trocar cholecystectomy
Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach
Active Comparator: Standard lap cholecystectomy
Standard lap choly
Procedure: Standard laparoscopic cholecystectomy
Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00732550

Hadassah Medical Organization Ein-Kerem campus
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Yoav Mintz, MD Hadassah Medical Organization
Study Chair: Avraham Rivkind, MD Hadassah Medical Organization
  More Information

Responsible Party: Hadassah Medical Organization Identifier: NCT00732550     History of Changes
Other Study ID Numbers: Single trocar HMO-CTIL
Study First Received: August 3, 2008
Last Updated: April 13, 2016

Keywords provided by Hadassah Medical Organization:

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical processed this record on May 24, 2017