PROphylactic Mesh to prevent Incisional hernias at the former Stoma Site: the PROMISS-trial
Phase 3
Withdrawn
- Conditions
- Aandoeningen van de buikwandIncisional hernia at the former stoma site.10041297
- Registration Number
- NL-OMON46765
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
- Age * 18 years
- Diagnosed with colorectal carcinoma
- Bowel resection following stoma formation, intended to be temporary.
- Elective surgery
- ASA-score I-III
- Signed informed consent
Exclusion Criteria
- Emergency operation
- Peritonitis (i.e. bowel perforation)
- Bowel obstruction
- A life expectancy of less than 2 years (distant metastasis i.e. located in the liver, peritoneum, lung, cerebral or bone)
- Earlier hernia repair with mesh placed in a 10cm proximity of the future stoma site.
- Chronic use of antibiotics
- Chronic use of immunosuppressive medication
- ASA-score IV or above
- Not able to sign informed consent
- Patient being unable to speak Dutch
- Patient allergic to one of the components of the mesh
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary goal of this study is to investigate if the incidence of incisional<br /><br>hernias at the former stoma site is reduced by preventive mesh placement.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Occurrence of parastomal hernia<br /><br>- Occurrence of stoma prolapse<br /><br>- Occurrence of mesh infection<br /><br>- Occurrence of wound infections<br /><br>- Occurrence of seroma<br /><br>- Quality of life score<br /><br>- Operation length<br /><br>- Time to stoma reversal<br /><br>- Cost-effectiveness </p><br>