Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.
Recruiting · NCT06220058 · Interventional (participants receive a specific treatment) · Lead sponsor: Fernandez Zamora
View the official record on ClinicalTrials.gov →Interventions studied
Closure of the midline laparotomy using the "small bites" techniqueClosure of the midline laparotomy using the "small bites" technique with an absorbable PP mesh
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona, - Girona, Catalonia, Spain