Laparoscopic Ventral Hernia Repair by Heavy Weight or Lig... | NCT00573105

Studies
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

NCT00573105

Sponsor

University Hospital, Ghent

Status

Terminated

Last Update Posted

Jan 26, 2011Estimated

Enrollment

110Actual

Phase

Not Applicable

Conditions

Ventral Hernia

Interventions

Laparoscopic Ventral hernia repair by heavy weight mesh
Laparoscopic Ventral hernia repair by lighter weight mesh

Countries

Belgium

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

Jan 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow inclusion rate

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Dec 11, 2007

First Submission Date that Met QC Criteria

Dec 11, 2007

First Posted Date

Dec 13, 2007Estimated

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

Jan 25, 2011

Last Update Posted Date

Jan 26, 2011Estimated

Name	Class
C. R. Bard	INDUSTRY

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

General

- antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery
Laparoscopic surgery
- at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
- with or without anchoring transparietal sutures or double crown technique

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Laparoscopic Ventral hernia repair by heavy weight mesh	Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh
2	Experimental	Laparoscopic Ventral hernia repair by lighter weight mesh	Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic Ventral hernia repair by heavy weight mesh	Procedure	Laparoscopic Ventral hernia repair by heavy weight mesh	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recurrence rate		after 1 year

Secondary Outcomes

Measure	Description	Time Frame
morbidity rate		perioperative
quality of life		after 1 year
postoperative pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

written informed consent from the patient or his/her legal representative
ventral hernia requiring elective surgical repair

Exclusion Criteria:

no written informed consent
'hostile' abdomen; open abdomen treatment
contraindication to pneumoperitoneum
emergency surgery (incarcerated hernia)
parastomal hernia

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
Frederik Berrevoet, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D006555	Hernia, Ventral

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided