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NCT00961506 Clinical Trial

Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

Gallbladder Disease Clinical Trial

Official title:
Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00961506
Other study ID # CER-08-145a
Secondary ID
Status Completed
Phase Phase 2
First received August 18, 2009
Last updated August 18, 2009
Start date March 2009
Est. completion date August 2009

Study information
Verified date August 2009
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority Switzerland: Federal Office of Public Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- gallbladder disease Age: 18-99

Exclusion Criteria:

- intolerance to laparoscopy

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Switzerland University Hospital Geneva Geneva

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body image scale 1 months No
Secondary pain VAS 10 days No
Secondary Analgesic requirement No
Secondary time to return to work No
Secondary scar scale 1 months No
See also
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Completed NCT01772745 - The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy N/A
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Completed NCT01571479 - The Feasibility and Safety of a Three-Port Laparoscopic Cholecystectomy Using a 2-mm Mini-Instrument N/A
Completed NCT00889928 - A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance N/A
Completed NCT00832767 - SILS™ Port Laparoscopic Cholecystectomy Post Market Study N/A