Comparing two types of mesh for closing abdominal surgery wounds in high-risk colorectal patients
Comparison Between the Use of a Polypropylene (PP) Prophylactic Mesh and a Polyvinylidene Fluoride (PVDF) Mesh in the Closure of Midline Laparotomy in Emergency Colorectal Surgery for High-risk Patients of Incisional Hernia. Impact on Surgical Wound Infection.
This study is testing whether two different types of mesh can help high-risk colorectal surgery patients heal better and avoid complications like hernias and infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta Academic / other |
| Locations | 1 site (Girona) |
| Trial ID | NCT06220045 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of polypropylene (PP) and polyvinylidene fluoride (PVDF) meshes in closing midline laparotomy incisions in patients undergoing emergency colorectal surgery. It focuses on high-risk individuals who are more susceptible to complications such as incisional hernias and surgical wound infections. By evaluating the incidence of these complications, the study aims to provide valuable evidence that could influence surgical practices and guidelines. The research is particularly relevant given the lack of existing literature on this specific comparison in emergency settings.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with colorectal conditions requiring urgent surgical intervention via midline laparotomy.
Not a fit: Patients with psychiatric illnesses or those unable to understand the informed consent process may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing high-risk colorectal surgeries.
How similar studies have performed: While there is limited direct comparison of PP and PVDF meshes in emergency colorectal surgery, similar studies in other surgical contexts have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy. * Patients undergoing urgent laparoscopic surgery but requiring conversion to midline laparotomy. * Need for urgent surgical treatment involving the colon and/or rectum, even in the presence of other abdominal pathologies. * Age over 18 years. * Signed informed consent (IC) from both the patient and the investigator * Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD. * BMI ≥ 35 kg/m2. * Re-laparotomies. Exclusion Criteria: * Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent. * Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).
Where this trial is running
Girona
- Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona, — Girona, Spain (Recruiting)
Study contacts
- Study coordinator: Frank Fernández, Dr.
- Email: cirurgia.girona.ics@gencat.cat
- Phone: 972 94 02 60
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.