Prevent Trial;Prevention of parastomal hernia during construction of a colostomy by reinforcing the bowel wall with a polypropylene mesh. ;A multicentre randomized controlled trial.

Prevent Trial;Prevention of parastomal hernia during construction of a colostomy by reinforcing the bowel wall with a polypropylene mesh. ;A multicentre randomized controlled trial. - Prevent Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32175

Enrollment

150

Registered

2009-01-05

Start date

2010-01-04

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

hernia next to the stoma

Interventions

To reduce the chance of complications caused by the preventive mesh placement a lightweight partially absorbable monofilament mesh is chosen, Ultrapro (Ethicon, 70 euro). The structure of the mesh a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusioncriteria: 1. The creation of a presumed permanent colostomy, in a (semi) elective setting. 2. Age >18 years and

Exclusion criteria

Exclusion criteria: Exclusioncriteria: 1. A survival shorter than 12 months is expected or metastatic disease is present. 2. Correction of a previous created colostomy, unless a new one is created. 3. A *fresh* bowel wall at the stoma site is not present. 4. An important language barier. 5. Hinchey 4 (generalised faecal peritonitis) is expected.

Design outcomes

Primary

Measure	Time frame
Patientcaracteristics including medical history, immunosuppressive diseases and indication for surgery will be documented. (see addendum A for CRF) The preoperative quality of life will be registered using the SF-36 questionsform. Peroperative technical data of the colostomy and potential riskfactors for complications will be documented. Postoperatively the presence of infection will be registered according to the Centers of disease control (CDC) criteria. These are the standard criteria in the USA and the Netherlands and are part of the follow-up data forms. Patientscomplaints regarding the stoma will be registered. This will be done by using the SF-36 and painscore according to Korff. (see addendum B) Physical exam will be performed to register the potential presence of a parastomal hernia. The stoma dressing has to be removed! Definition of a parastomal hernia: a swelling next to the stoma during valsalva in upright or flat position. When there are complaint or suspision of a parastomale hernia an MRI scan is performed unless for other reasons a CT-scan is performed. The treatment of a potential parastomal hernia will be according to the regular standards.	—

Measure

Time frame

Patientcaracteristics including medical history, immunosuppressive diseases and indication for surgery will be documented. (see addendum A for CRF) The preoperative quality of life will be registered using the SF-36 questionsform. Peroperative technical data of the colostomy and potential riskfactors for complications will be documented. Postoperatively the presence of infection will be registered according to the Centers of disease control (CDC) criteria. These are the standard criteria in the USA and the Netherlands and are part of the follow-up data forms. Patientscomplaints regarding the stoma will be registered. This will be done by using the SF-36 and painscore according to Korff. (see addendum B) Physical exam will be performed to register the potential presence of a parastomal hernia. The stoma dressing has to be removed! Definition of a parastomal hernia: a swelling next to the stoma during valsalva in upright or flat position. When there are complaint or suspision of a parastomale hernia an MRI scan is performed unless for other reasons a CT-scan is performed. The treatment of a potential parastomal hernia will be according to the regular standards.

—

Secondary

Measure	Time frame
The costs will be calculated by comparing the additional costs of the mesh placement with the therapeutic costs of a surgical procedure of a parastomal hernia including the time off work.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)