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Clinical Trials/NL-OMON46765
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Withdrawn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

Sponsor
Medisch Universitair Ziekenhuis Maastricht

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