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.

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,
RECRUITING
Girona
Contact Information
Primary
Frank Fernández, Dr.
cirurgia.girona.ics@gencat.cat
972 94 02 60
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2025-01-15
Participants
Target number of participants: 60
Treatments
Experimental: 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
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

This content was sourced from clinicaltrials.gov