Safety and Cost-effectiveness Study of Single Port Laparo... | NCT00974194

Studies
Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies

NCT00974194

Sponsor

University of Lausanne Hospitals

Status

Completed

Last Update Posted

Oct 17, 2018Actual

Enrollment

268Actual

Phase

Not Applicable

Conditions

Cholecystolithiasis

Interventions

Single Trocar CCK
Standard CCK

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

Oct 2018

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

Sep 2009Actual

Primary Completion Date

Sep 1, 2017Actual

Completion Date

Sep 1, 2018Actual

First Submitted Date

Sep 8, 2009

First Submission Date that Met QC Criteria

Sep 9, 2009

First Posted Date

Sep 10, 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

Oct 12, 2018

Last Update Posted Date

Oct 17, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicolas DEMARTINES, professor of surgery, University of Lausanne HospitalsPrincipal Investigator

Lead Sponsor

University of Lausanne HospitalsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.

Detailed Description

Design:

Prospective Randomized Controlled trial
Population analysis based on Intention To Treat
Patient and data analyzer blinded (double-blind trial)

Outcomes observed:

Primary: pain
Secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, CO2 consumption

Nbr of patients included: 260

Port used: Triport, Olympus

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

268Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SinglePort CCK	Experimental	CCK using Triport	Procedure: Single Trocar CCK
LS CCK	Active Comparator	CCK using three or four trocars	Procedure: Standard CCK

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single Trocar CCK	Procedure	CCK using Triport	SinglePort CCK
Standard CCK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain (value on a Visual Analog Scale)	VAS	1 day
Pain (value on a Visual Analog Scale)	VAS	2 days
Pain (value on a Visual Analog Scale)	VAS	1 month
Pain (value on a Visual Analog Scale)	VAS	3 month
Pain (value on a Visual Analog Scale)	VAS	1 year

Secondary Outcomes

Measure	Description	Time Frame
Complications	In euro	1 month
Operative time	In euro	Operative day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cholecystolithiasis
Age 18 to 75 y.o.
BMI < 35

Exclusion Criteria:

Immunodeficiency
Choledocholithiasis
Previous upperGI open surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Allemann, MD	CHV/CHUV	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Lausanne		Lausanne		1011	Switzerland

Label	URL
Internet page of our departement	View source

Condition Browse Module

MeSH Terms

ID	Term
D041761	Cholecystolithiasis

Ancestor Terms

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D005705	Gallbladder Diseases

Browse Leaves

Not provided

Browse Branches

Not provided