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
Recruitment status was Recruiting
Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00732550
First received: August 3, 2008
Last updated: August 11, 2008
Last verified: July 2008
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 3, 2008 | ||||||||
| Last Updated Date | August 11, 2008 | ||||||||
| Start Date ICMJE | July 2008 | ||||||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00732550 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy | ||||||||
| Official Title ICMJE | Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy | ||||||||
| Brief Summary | The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Cholelithiasis | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | September 2009 | ||||||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00732550 | ||||||||
| Other Study ID Numbers ICMJE | Single trocar HMO-CTIL | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Yoav Mintz MD, Hadassah Medical Organization | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | July 2008 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||