Actively Recruiting
Comparison of Polypropylene and Polyvinylidene Fluoride Meshes in Midline Laparotomy Closure for High-Risk Emergency Colorectal Surgery Patients: Impact on Surgical Wound Infection and Incisional Hernia
Led by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Updated on 2024-10-08
60
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the use of two different mesh materials, polypropylene (PP) and polyvinylidene fluoride (PVDF), for closing midline laparotomy incisions in emergency colorectal surgery. This study focuses on high-risk patients for incisional hernia and aims to provide evidence on differences in surgical wound infection rates and related complications like chronic pain. There are currently no specific guidelines comparing these mesh types in this surgical context. Participants undergoing emergency colorectal surgery will have their midline laparotomy closed using a "small bites" technique combined with either a prophylactic suprafascial PVDF mesh or a PP mesh. Randomization occurs at the time of laparotomy closure to assign patients to one of these two groups. Surgeries are performed according to each patient's pathology. During the study, researchers will monitor surgical wound infection incidence for 30 days after surgery. They will also track rates of incisional hernia at one year and morbidity and mortality within 90 days postoperatively. Participants will be followed through these periods to assess outcomes and any complications related to the mesh materials used.
CONDITIONS
Brief 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
Eligibility Criteria
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 with other abdominal pathologies
- Age over 18 years
- Signed informed consent from both patient and investigator
- Severe chronic obstructive pulmonary disease (COPD) according to GOLD classification or decompensated COPD
- BMI of 35 kg/m2 or higher
- Patients requiring re-laparotomies
You will not qualify if you...
- Patients with psychiatric illnesses, addictions, or conditions preventing understanding of informed consent
- Inability to read or understand informed consent in Catalan or Spanish languages
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo midline laparotomy surgery using the small bites technique with random assignment to receive either a polyvinylidene fluoride mesh or a polypropylene mesh for closure.
1 surgical visit and immediate post-operative hospital stay
Duration - 30 days post-surgery
Participants are monitored for surgical wound infection and other outcomes following surgery.
Visits during the first 30 days after surgery to assess wound healing and infection
Duration - Up to one year post-surgery
Participants are followed to assess the rate of incisional hernia and morbidity and mortality after surgery.
Periodic follow-up visits up to one year after surgery
Trial Site Locations
Total: 1 location
1
Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,
Girona, Spain, 17001
Actively Recruiting
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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