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Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00732550
Recruitment Status : Active, not recruiting
First Posted : August 12, 2008
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Cholelithiasis Procedure: Single trocar cholecystectomy Procedure: Standard laparoscopic cholecystectomy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
Study Start Date : July 2008
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732550


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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00732550     History of Changes
Other Study ID Numbers: Single trocar HMO-CTIL
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by Hadassah Medical Organization:
cholelithiasis
cholecystitis

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical