Comparing two techniques for closing abdominal surgery incisions to prevent hernias
Comparison Between the Use of a Prophylactic Polypropylene Mesh and the "Small Bites" Technique in Midline Laparotomy Closure for Emergency Colorectal Surgery for Incisional Hernia Prevention
This study tests whether a new way of closing surgery cuts can help prevent hernias in patients who need emergency surgery for bowel issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta Academic / other |
| Locations | 1 site (Girona, Catalonia) |
| Trial ID | NCT06220058 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two techniques for closing midline laparotomy incisions in emergency colorectal surgeries: the traditional closure method and the 'small bites' technique combined with absorbable polypropylene mesh. The goal is to gather evidence on the incidence of incisional hernias and related complications following these surgical procedures. By focusing on patients requiring urgent surgical intervention for colorectal conditions, the study seeks to address gaps in current guidelines and provide clearer recommendations for surgical practices.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with colorectal conditions requiring urgent surgical treatment via midline laparotomy.
Not a fit: Patients with severe COPD, high BMI, or those undergoing re-laparotomies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced rates of incisional hernias for patients undergoing emergency colorectal surgery.
How similar studies have performed: While there is limited consensus in existing literature, this study aims to fill a significant gap in evidence regarding emergency abdominal wall closure techniques.
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 necessitating conversion to midline laparotomy. * Urgent surgical intervention required at the level of the colon and/or rectum, even in the presence of other abdominal pathologies. * Age over 18 years. * Signed informed consent (IC) from the patient and the investigator. Exclusion Criteria: * Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD. * BMI ≥ 35 kg/m2. * Re-laparotomies. * 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, Catalonia
- Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona, — Girona, Catalonia, Spain (Recruiting)
Study contacts
- Study coordinator: Frank Fernández, Dr.
- Email: frankafernandez.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.