Prevention of Parastomal Hernia by Primary Mesh Insertion

Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641342

Enrollment

198

Registered

2008-03-24

Start date

2007-03-31

Completion date

2015-02-28

Last updated

2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parastomal Hernia

Keywords

Parastomal hernia, Onlay mesh, Sublay mesh, Pain, Health questionnaire

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.

Interventions

DEVICEonlay mesh

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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
Disease specific and general health questionnaire	one year after surgery, reassessed after 2, 3 and 5 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026