Prevention of incisional hernias with prophylactic synthetic mesh placement during stoma reversal
Phase 3
Recruiting
- Conditions
- hernia cicatricalisincisional hernia10000073
- Registration Number
- NL-OMON47547
- Lead Sponsor
- Meander Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Age >18 years
Signed informed consent
Exclusion Criteria
Not able to sign informed consent
Connective tissue disorder
Intraperitoneal dialysis
Immunodeficiency
Use of immunosupressive medication (including high dose corticosteroids)
Previous intraperitoneal mesh placement <3cm of the stoma closure wound
allergy of contra-indication for mesh placement
Pregnancy or pregnancy wish in the future
Inflammatory bowel disease as indication for stoma construction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incisional hernia rate as detected by abdominal ultrasound at 1 year following<br /><br>stoma closure. An incisional hernia was defined as an opening or defect in the<br /><br>abdominal wall with protruding tissue trough it at the stomal incision site. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Clinical diagnosis of incisional hernia at 1 year follow-up<br /><br>- Number of patients requiring surgical intervention for correction of a<br /><br>incisional hernia<br /><br>- Postoperative pain<br /><br>- 30-day mortality, cause of death<br /><br>- 30-day morbidity, specifically focussing on infectious complications.<br /><br>- 30-day re-admission and re-operation rate<br /><br>- Quality of life<br /><br>- Cost-effectiveness</p><br>