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

Launched by INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE GIRONA DR. JOSEP TRUETA · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two types of mesh materials—PP (polypropylene) and PVDF (polyvinylidene fluoride)—used to close the abdomen after surgery for colorectal issues, especially in patients at high risk for complications like hernias and infections. The goal is to find out if one type of mesh is better than the other in preventing these problems after emergency surgeries. This research is important because current guidelines do not specify which mesh material is preferable, and more evidence is needed to guide doctors in making the best choices for their patients.

To participate in this trial, individuals must be at least 18 years old and diagnosed with a condition that requires urgent surgery on the colon or rectum. This includes patients who need immediate surgery or those who start with a minimally invasive approach but need to switch to a larger incision for better treatment. If you or a loved one fits these criteria and is interested in joining the study, you will need to provide signed consent and will be closely monitored during the process. This trial aims to improve outcomes for patients undergoing this type of surgery by understanding the best materials to use for abdominal closure.

Gender

ALL

Eligibility 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).