NCT00961506

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

Enrollment Period

3 months

First QC Date

August 18, 2009

Last Update Submit

August 18, 2009

Conditions

Gallbladder Disease

Keywords

cholecystectomygallbladderlaparoscopylaparoendoscopic

Outcome Measures

Primary Outcomes (1)

  • Body image scale

    1 months

Secondary Outcomes (4)

  • pain VAS

    10 days

  • Analgesic requirement

  • time to return to work

  • scar scale

    1 months

Study Arms (2)

LESS cholecystectomy

EXPERIMENTAL

LESS cholecystectomy

Procedure: LESS cholecystectomy

Laparoscopic cholecystectomy

ACTIVE COMPARATOR

Laparoscopic cholecystectomy

Procedure: Laparoscopic cholecystectomy

Interventions

LESS cholecystectomyPROCEDURE

LESS cholecystectomy

LESS cholecystectomy
Laparoscopic cholecystectomyPROCEDURE

laparoscopic cholecystectomy

Laparoscopic cholecystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • gallbladder disease Age: 18-99

You may not qualify if:

  • intolerance to laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Gallbladder Diseases

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Pascal Bucher, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 19, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations

CH(1)