Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT00961506

First received: August 18, 2009

Last updated: NA

Last verified: August 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 18, 2009

Last Updated Date

August 18, 2009

Start Date ^ICMJE

March 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Body image scale [ Time Frame: 1 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

pain VAS [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Analgesic requirement [ Designated as safety issue: No ]
time to return to work [ Designated as safety issue: No ]
scar scale [ Time Frame: 1 months ] [ Designated as safety issue: No ]

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

Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

Official Title ^ICMJE

Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

Brief Summary

Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gallbladder Disease

Intervention ^ICMJE

Procedure: LESS cholecystectomy
LESS cholecystectomy
Procedure: Laparoscopic cholecystectomy
laparoscopic cholecystectomy

Study Arm (s)

Experimental: LESS cholecystectomy
LESS cholecystectomy

Intervention: Procedure: LESS cholecystectomy
Active Comparator: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy

Intervention: Procedure: Laparoscopic cholecystectomy

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

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

gallbladder disease Age: 18-99

Exclusion Criteria:

intolerance to laparoscopy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00961506

Other Study ID Numbers ^ICMJE

CER-08-145a

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital, Geneva

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pascal Bucher, MD

University Hospital, Geneva

Information Provided By

University Hospital, Geneva

Verification Date

August 2009

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

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