NL-OMON46765WithdrawnPhase 3
PROphylactic Mesh to prevent Incisional hernias at the former Stoma Site: the PROMISS-trial - The PROMISS-trial
Medisch Universitair Ziekenhuis Maastricht0 sites130 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Enrollment
- 130
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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