Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2008 by Hadassah Medical Organization.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00732550

First received: August 3, 2008

Last updated: August 11, 2008

Last verified: July 2008

History of Changes

Purpose

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Gallstones

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess pain associated with the single trocar approach [ Time Frame: Continuous ] [ Designated as safety issue: No ]
To assess scar formation associated with single trocar approach [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732550

Contacts

Contact: Arik Tzukert, DMD	00-972-2-6776095	arik@hadassah.org.il
Contact: Hadas Lemberg, PhD	00 972 2 6777572	lhadas@hadassah.org.il

Locations

Israel
Hadassah Medical Organization Ein-Kerem campus	Recruiting
Jerusalem, Israel
Contact: Yoav Mintz, MD
Principal Investigator: Yoav Mintz, MD

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

No publications provided

Responsible Party:	Yoav Mintz MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00732550 History of Changes
Other Study ID Numbers:	Single trocar HMO-CTIL
Study First Received:	August 3, 2008
Last Updated:	August 11, 2008
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on May 22, 2013

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