Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Hernia Incisional | — | UNRESOLVED | — |
| Wound Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polyvinylidene fluoride mesh | Combination Product | — | UNRESOLVED |
| Prophylactic polypropylene mesh | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Polyvinylidene fluoride mesh
- description
- In all patients, surgery will be performed according to their individual pathology. Once midline laparotomy closure is initiated, randomization will be conducted, and patients will be assigned to one of the two groups. PVDF Group (Polyvinylidene Fluoride Mesh): Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh
- interventionNames
- Combination Product: Polyvinylidene fluoride mesh
- type
- EXPERIMENTAL
- label
- Prophylactic polypropylene mesh
- description
- In all patients, surgery will be performed according to their individual pathology. Once midline laparotomy closure is initiated, randomization will be conducted, and patients will be assigned to one of the two groups. PP Group (Polypropylene Mesh): Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.
- interventionNames
- Combination Product: Prophylactic polypropylene mesh
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available