Prevention of Parastomal Hernia by Primary Mesh Insertion | NCT00641342

Studies
Prevention of Parastomal Hernia by Primary Mesh Insertion

NCT00641342

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Terminated

Last Update Posted

Feb 7, 2014Estimated

Enrollment

198Estimated

Phase

Phase 2Phase 3

Conditions

Parastomal Hernia

Interventions

onlay mesh

Countries

Denmark

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

Mar 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of recruitment from different study sites and due to structural changes in the included centers

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Feb 2015Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

Mar 18, 2008

First Submission Date that Met QC Criteria

Mar 21, 2008

First Posted Date

Mar 24, 2008Estimated

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

Feb 6, 2014

Last Update Posted Date

Feb 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ismail Gögenur, Dr, University Hospital, Gentofte, CopenhagenPrincipal Investigator

Lead Sponsor

University Hospital, Gentofte, CopenhagenOTHER

Collaborators

Name	Class
Aarhus University Hospital	OTHER
Hvidovre University Hospital	OTHER
Copenhagen University Hospital at Herlev	OTHER
Esbjerg Hospital - University Hospital of Southern Denmark

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

Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

198Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
onlay mesh	Active Comparator	Device: onlay mesh
sublay mesh	Active Comparator	Device: onlay mesh
no mesh	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
onlay mesh	Device	StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)	onlay mesh sublay mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parastomal hernia verified by CT-scan		one year after surgery, reassessed after 2, 3 and 5 years

Secondary Outcomes

Measure	Description	Time Frame
Clinically detected parastomal hernia		one year after surgery, reassessed after 2, 3 and 5 years
Pain		one year after surgery, reassessed after 2, 3 and 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.

Exclusion Criteria:

ASA > 3
Acute surgery
Known immune deficiency
Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.
Pregnancy
Known inflammatory bowel disease
Lack of written informed consent

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
Ismail Gögenur	University Hospital of Copenhagen, GEntofte	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital, Hvidovre		Hvidovre	Copebhagen	2630	Denmark
Copenhagen University Hospital, Gentofte

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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