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
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-02-01
2025-01-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Polyvinylidene fluoride mesh
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
Polyvinylidene fluoride mesh
Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh.
Prophylactic polypropylene mesh
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.
Prophylactic polypropylene mesh
Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.
Interventions
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Polyvinylidene fluoride mesh
Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh.
Prophylactic polypropylene mesh
Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.
Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).
18 Years
ALL
No
Sponsors
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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
OTHER
Responsible Party
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Fernandez Zamora
Principal Investigator
Locations
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Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,
Girona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023.226
Identifier Type: -
Identifier Source: org_study_id
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