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

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

Inclusion Criteria8

  • 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 Criteria2

  • 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).

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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