Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00732550
First received: August 3, 2008
Last updated: April 13, 2016
Last verified: April 2016

August 3, 2008
April 13, 2016
July 2008
September 2018   (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.
 
Active, not recruiting
20
September 2018
September 2018   (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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00732550
Single trocar HMO-CTIL
No
Not Provided
Not Provided
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
April 2016

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