NCT06220045 Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.
| NCT ID | NCT06220045 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2025-01-15 |
Trial Parameters
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Brief Summary
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.
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).
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