Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.

Recruiting · NCT06220045 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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Colorectal Cancer

Interventions studied

Polyvinylidene fluoride meshProphylactic polypropylene mesh

What this trial is about

In the latest guidelines for abdominal wall closure in emergency surgery published in the World Journal of Emergency Surgery (WJES) in 2023, no specific recommendations are made in this regard. Current literature does not provide any articles comparing these two types of mesh materials (PP vs PVDF) in emergency colorectal surgery. It is necessary to conduct a study comparing these two types of mesh materials, specifically in high-risk patients for incisional hernia and emergency colorectal surgery. This study aims to contribute to generating evidence regarding differences in wound infection incidence and potential subsequent complications, such as chronic pain. It is essential to conduct a study comparing different methods of laparotomy closure, specifically in emergency colorectal surgery, to contribute valuable evidence regarding the incidence of incisional hernia and potential 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 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 it is running

1 location listed.

Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona, - Girona, Spain

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →