Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06220045

Comparison of Polypropylene and Polyvinylidene Fluoride Meshes for Midline Laparotomy Closure in High-Risk Emergency Colorectal Surgery Patients Evaluating Incisional Hernia and Surgical Wound Infection

Led by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Updated on 2024-10-08

60

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two types of mesh materials, polypropylene (PP) and polyvinylidene fluoride (PVDF), used in midline laparotomy closure during emergency colorectal surgery in high-risk patients. The study responds to a lack of specific guidelines and direct comparisons in current literature, aiming to provide evidence on differences in wound infection rates and complications like incisional hernia and chronic pain. This research focuses on improving surgical outcomes in urgent colorectal procedures. Participants will undergo midline laparotomy closure using the "small bites" technique combined with either a prophylactic suprafascial polypropylene mesh or a polyvinylidene fluoride mesh. These interventions are applied during emergency colorectal surgeries, including cases initially started laparoscopically but converted to open surgery. The study targets patients at high risk for incisional hernia to evaluate the impact of the two mesh types. During the study, participants' surgical wounds will be monitored for infection occurrence up to 30 days after surgery. Researchers will collect data on wound healing and potential complications. Patients must provide informed consent and will be assessed for eligibility based on specific health and surgical criteria. The study aims to improve understanding of wound infection incidence and hernia prevention in this high-risk group.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 from both the patient and the investigator.
  • Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.
  • Body mass index (BMI) of 35 kg/m2 or higher.
  • Re-laparotomies.
Not Eligible

You will not qualify if you...

  • 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).

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Girona, Spain, 17001

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Research Team

F

Frank Fernández, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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