NCT06220058Recruiting
Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The 2023 World Journal of Emergency Surgery guidelines couldn't provide a recommendation for emergency abdominal wall closure due to insufficient consensus (\>80% required). Available evidence, predominantly retrospective and heterogeneous, lacks differentiation between urgent and elective colorectal surgeries. Therefore, we advocate for a study comparing laparotomy closures in emergency colorectal surgery to contribute evidence on incisional hernia incidence and subsequent complications.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- First submitted
- 11 Jan 2024
- Start date
- Feb 2024
- Primary completion date
- Jan 2026
- Lead sponsor
- Fernandez Zamora
- Diseases
- Colorectal cancer
- NCT number
- NCT06220058
What you commit to
- Study type: Interventional
- Planned participants: 148
- From Feb 2024 to the primary completion date, Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.
- Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent.
Other
- BMI ≥ 35 kg/m2.
- Re-laparotomies.
- Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona, Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.