RecruitingNot ApplicableNCT06220045

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

Comparison Between the Use of a Polypropylene (PP) Prophylactic Mesh and a Polyvinylidene Fluoride (PVDF) Mesh in the Closure of Midline Laparotomy in Emergency Colorectal Surgery for High-risk Patients of Incisional Hernia. Impact on Surgical Wound Infection.

Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Enrollment

60 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Hernia Incisional Wound Infection

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This surgical trial is comparing two types of mesh material — polypropylene (PP) and PVDF — used to reinforce the abdominal wall closure after emergency surgery on the colon or rectum. The goal is to see which mesh better prevents incisional hernia (a bulge through the surgical wound) and wound infections after major abdominal surgery. **You may be eligible if...** - You need urgent colorectal surgery via a midline abdominal incision - You have a BMI of 35 or higher, or have severe COPD, or are undergoing a repeat laparotomy (re-operation) - You are 18 or older and can provide informed consent in Spanish or Catalan **You may NOT be eligible if...** - You have a psychiatric illness, addiction, or cognitive impairment preventing you from understanding the consent form - You are unable to read or understand Spanish or Catalan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTPolyvinylidene fluoride mesh

Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh.

COMBINATION_PRODUCTProphylactic polypropylene mesh

Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.

Locations(1)

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

Girona, Spain

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NCT06220045

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