NCT00641342

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

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, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 7, 2014

Status Verified

March 1, 2008

Enrollment Period

7.9 years

First QC Date

March 18, 2008

Last Update Submit

February 6, 2014

Conditions

Parastomal Hernia

Keywords

Parastomal herniaOnlay meshSublay meshPainHealth questionnaire

Outcome Measures

Primary Outcomes (1)

  • Parastomal hernia verified by CT-scan

    one year after surgery, reassessed after 2, 3 and 5 years

Secondary Outcomes (3)

  • 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

  • Disease specific and general health questionnaire

    one year after surgery, reassessed after 2, 3 and 5 years

Study Arms (3)

onlay mesh

ACTIVE COMPARATOR
Device: onlay mesh

sublay mesh

ACTIVE COMPARATOR
Device: onlay mesh

no mesh

NO INTERVENTION

Interventions

onlay meshDEVICE

StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)

onlay meshsublay mesh

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Copenhagen University Hospital, Hvidovre

Hvidovre, Copebhagen, 2630, Denmark

Location

Copenhagen University Hospital, Gentofte

Hellerup, Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ismail Gögenur

    University Hospital of Copenhagen, GEntofte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

March 1, 2007

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 7, 2014

Record last verified: 2008-03

Locations

DK(2)