Status:
UNKNOWN
PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Incisional Hernia
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Rationale: Approximately 7000 stomata are created in the Netherlands every year. The occurrence of a parastomal herniation is high, with a reported incidence of 4-48%. Also, the former stoma site is ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03750942
Start Date
March 1 2019
End Date
March 1 2023
Last Update
November 23 2018
Active Locations (1)
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1
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6229 HX