Prevention of Parastomal Hernia by Primary Mesh Insertion

This study has been terminated.
(Lack of recruitment from different study sites and due to structural changes in the included centers)
Sponsor:
Collaborators:
Aarhus University Hospital
Hvidovre University Hospital
Copenhagen University Hospital at Herlev
Sydvestjydsk sygehus, Esbjerg
Hillerod Hospital, Denmark
Vejle Hospital
Roskilde County Hospital
Information provided by (Responsible Party):
Ismail Gögenur, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00641342
First received: March 18, 2008
Last updated: February 6, 2014
Last verified: March 2008

March 18, 2008
February 6, 2014
March 2007
February 2015   (final data collection date for primary outcome measure)
Parastomal hernia verified by CT-scan [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ] [ Designated as safety issue: No ]
Parastomal hernia verified by CT-scan
Complete list of historical versions of study NCT00641342 on ClinicalTrials.gov Archive Site
  • Clinically detected parastomal hernia [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ] [ Designated as safety issue: No ]
  • Disease specific and general health questionnaire [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ] [ Designated as safety issue: No ]
  • Clinically detected parastomal hernia
  • Pain
  • Disease specific and general health questionnaire
Not Provided
Not Provided
 
Prevention of Parastomal Hernia by Primary Mesh Insertion
Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Parastomal Hernia
Device: onlay mesh
StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)
  • Active Comparator: onlay mesh
    Intervention: Device: onlay mesh
  • Active Comparator: sublay mesh
    Intervention: Device: onlay mesh
  • No Intervention: no mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
198
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00641342
PMPC
No
Ismail Gögenur, University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen
  • Aarhus University Hospital
  • Hvidovre University Hospital
  • Copenhagen University Hospital at Herlev
  • Sydvestjydsk sygehus, Esbjerg
  • Hillerod Hospital, Denmark
  • Vejle Hospital
  • Roskilde County Hospital
Principal Investigator: Ismail Gögenur University Hospital of Copenhagen, GEntofte
University Hospital, Gentofte, Copenhagen
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP