Actively Recruiting
Comparison of Prophylactic Polypropylene Mesh Versus "Small Bites" Technique for Midline Laparotomy Closure in Emergency Colorectal Surgery to Prevent Incisional Hernia
Led by Fernandez Zamora · Updated on 2024-10-08
148
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different techniques for closing the midline laparotomy incision in emergency colorectal surgery to prevent incisional hernias. This study aims to provide evidence on the incidence of incisional hernia and related complications, addressing the lack of consensus in current guidelines and the limited quality of existing research. The study compares closure using the "small bites" technique alone with closure using the same technique plus a partially absorbable polypropylene mesh placed suprapubically. The "small bites" technique involves a specific method of suturing with a monofilament polydioxanone suture. When mesh is used, it is fixed with absorbable staples and sometimes sutures, and drainage is applied based on surgical discretion. Participants will undergo emergency colorectal surgery with either closure method randomly assigned. Researchers will monitor for incisional hernia occurrence one year after surgery and assess wound infections within 30 days and morbidity and mortality within 90 days post-operation. The study involves follow-up visits to evaluate these outcomes and ensure participant safety throughout the trial duration.
CONDITIONS
Brief Title
Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.
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 necessitating conversion to midline laparotomy.
- Urgent surgical intervention required at the level of the colon and/or rectum, even in the presence of other abdominal pathologies.
- Age over 18 years.
- Signed informed consent from the patient and the investigator.
You will not qualify if you...
- Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.
- Body mass index (BMI) equal to or greater than 35 kg/m2.
- Previous re-laparotomies.
- Patients with psychiatric illnesses, addictions, or disorders preventing understanding of the informed consent.
- Inability to read or understand the informed consent in Catalan or Spanish.
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 - Day of surgery and immediate post-operative period
Participants undergo emergency midline laparotomy closure using either the "small bites" technique alone or with an added suprapubic polypropylene mesh as part of their surgical treatment.
1 surgical procedure and hospital stay
Duration - 90 postoperative days
Participants are monitored for wound infection, morbidity, and mortality during recovery after surgery.
Approximately 3 follow-up visits during recovery
Duration - 1 year after surgery
Participants are followed to assess the incidence of incisional hernia after surgery.
1 follow-up visit at 1 year
Trial Site Locations
Total: 1 location
1
Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,
Girona, Catalonia, Spain, 17001
Actively Recruiting
Research Team
F
Frank Fernández, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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