Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2008 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00732550
First received: August 3, 2008
Last updated: September 17, 2014
Last verified: July 2008
  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:


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 2016
Estimated Primary Completion Date: September 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: September 17, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
cholelithiasis
cholecystitis

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

ClinicalTrials.gov processed this record on October 20, 2014