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

August 3, 2008
September 17, 2014
July 2008
September 2015   (final data collection date for primary outcome measure)
To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00732550 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cholelithiasis
  • Procedure: Single trocar cholecystectomy
    Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach
  • Procedure: Standard laparoscopic cholecystectomy
    Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy
  • Experimental: Single trocar
    Patients will undergo cholecystectomy by the single trocar approach
    Intervention: Procedure: Single trocar cholecystectomy
  • Active Comparator: Standard lap cholecystectomy
    Standard lap choly
    Intervention: Procedure: Standard laparoscopic cholecystectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2016
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Arik Tzukert, DMD 00-972-2-6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il
Israel
 
NCT00732550
Single trocar HMO-CTIL
No
Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Yoav Mintz, MD Hadassah Medical Organization
Study Chair: Avraham Rivkind, MD Hadassah Medical Organization
Hadassah Medical Organization
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP