Prospective Evaluation of Laparoendoscopic Single Site Ve... | NCT00961506

Studies
Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

NCT00961506

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Aug 19, 2009Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Gallbladder Disease

Interventions

LESS cholecystectomy
Laparoscopic cholecystectomy

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Aug 18, 2009

First Submission Date that Met QC Criteria

Aug 18, 2009

First Posted Date

Aug 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2009

Last Update Posted Date

Aug 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LESS cholecystectomy	Experimental	LESS cholecystectomy	Procedure: LESS cholecystectomy
Laparoscopic cholecystectomy	Active Comparator	Laparoscopic cholecystectomy	Procedure: Laparoscopic cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LESS cholecystectomy	Procedure	LESS cholecystectomy	LESS cholecystectomy

Measure	Description	Time Frame
Body image scale		1 months

Measure	Description	Time Frame
pain VAS		10 days
Analgesic requirement
time to return to work

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

gallbladder disease Age: 18-99

Exclusion Criteria:

intolerance to laparoscopy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pascal Bucher, MD	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Geneva		Geneva	Canton of Geneva	1211	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D005705	Gallbladder Diseases

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017081	Cholecystectomy, Laparoscopic

Ancestor Terms

ID	Term
D002763	Cholecystectomy
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided