An interventional study of Polyvinylidene fluoride mesh and Prophylactic polypropylene mesh in Colorectal Cancer, Wound Infection and Hernia Incisional, sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Not applicable, Interventional, and Treatment
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.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 60 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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
Combination Product: 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. PP Group (Polypropylene Mesh): Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.
Combination Product: Prophylactic polypropylene mesh
Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh.
Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.
Incidence of surgical wound infection
Compare the incidence of surgical wound infection between the two groups: Closure of midline laparotomy using the "small bites" technique associated with a suprafascial polypropylene mesh versus closure of midline laparotomy using the "small bites" technique associated with a suprafascial polyvinylidene fluoride mesh.
Time frame: 30 postoperative days
Rate of incisional hernia
Compare the rate of incisional hernia at one year post-surgery, postoperative complications, and abdominal pain at 6 and 12 months in both groups. Also, compare the rates of parastomal hernias.
Time frame: One year surgery
Morbidity and mortality rates
Comparison between the two groups on various aspects related to postoperative morbidity and mortality. Other aspects to be evaluated include the time of initiation of tolerance to solid oral diet, onset of ambulation, presence of anastomotic dehiscence, need for reinterventions, and occurrence of complications according to the Clavien-Dindo classification at 30 and 90 days, as well as the mortality rate at 90 days. Additionally, the aim is to compare the rate of initiation of adjuvant treatment within the first 6 weeks post-surgery, if indicated.
Time frame: 90 postoperative days
Plan to share: No
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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta