Using a special mesh to prevent hernias after colostomy surgery.
Randomized Double-blind Study on the Use of Resorbable Prosthetic Mesh "Ante Rectus" as a Prevention of Parastomal Hernia in Patients Undergoing Terminal Colostomy
This study is testing if using a special mesh during colostomy surgery can help prevent hernias and improve recovery for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Sanitaria Locale Napoli 2 Nord Academic / other |
| Locations | 2 sites (Naples and 1 other locations) |
| Trial ID | NCT04749329 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, safety, and potential benefits of using a resorbable biosynthetic mesh during colostomy procedures to prevent parastomal hernias. Parastomal hernias are common complications that can lead to significant morbidity and reduced quality of life for patients. The study aims to determine if placing this mesh at the time of colostomy can effectively reduce the incidence of hernias and improve patient outcomes. Participants will be monitored for safety and effectiveness following the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who require an endo colostomy and can provide informed consent.
Not a fit: Patients under 18 years old, those with a life expectancy of less than 24 months, pregnant individuals, or those on immunosuppressant therapy within two weeks prior to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of parastomal hernias and improve the quality of life for patients undergoing colostomy.
How similar studies have performed: Previous studies have shown promising results with the use of prophylactic mesh in preventing incisional hernias, suggesting potential success for this approach in parastomal hernia prevention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years * endo colostomy * Informed consent Exclusion Criteria: * age \< 18 years; * life expectancy \< 24 months (as estimated by the operating surgeon) * pregnancy * immunosuppressant therapy within 2 weeks before surgery
Where this trial is running
Naples and 1 other locations
- Aslnapoli2Nord — Naples, Italy (Recruiting)
- francesco Pizza — Naples, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Francesco Pizza, Md, PhD — Azienda Sanitaria Locale Napoli 2 Nord
- Study coordinator: Francesco Pizza, Md, PhD
- Email: francesco_pizza@libero.it
- Phone: 3338275449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.