Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polyvinylidene fluoride mesh, Prophylactic polypropylene mesh.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Wound Infection, Hernia Incisional. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Interventions
- Combination product Polyvinylidene fluoride mesh
Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh. - Combination product Prophylactic polypropylene mesh
Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.
Primary outcome measures
- Incidence of surgical wound infection [Time frame: 30 postoperative days]
Secondary outcome measures (2)
- Rate of incisional hernia [Time frame: One year surgery]
- Morbidity and mortality rates [Time frame: 90 postoperative days]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospit — Girona
Identifiers
NCT: NCT06220045 · 2023.226