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PROphylactic Mesh to prevent Incisional hernias at the former Stoma Site: the PROMISS-trial

PROphylactic Mesh to prevent Incisional hernias at the former Stoma Site: the PROMISS-trial - The PROMISS-trial

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46765
Enrollment
130
Registered
2018-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aandoeningen van de buikwand Incisional hernia at the former stoma site.

Interventions

A preventive mesh will be placed using a sublay keyhole technique (pre-peritoneal, retromuscular) at stoma formation. The mesh (versatex mesh 15x15cm) will be left in situ after stoma reversal and t

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary goal of this study is to investigate if the incidence of incisional hernias at the former stoma site is reduced by preventive mesh placement.

Secondary

MeasureTime frame
- Occurrence of parastomal hernia - Occurrence of stoma prolapse - Occurrence of mesh infection - Occurrence of wound infections - Occurrence of seroma - Quality of life score - Operation length - Time to stoma reversal - Cost-effectiveness

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)