Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.

Colorectal Cancer Clinical Trial

— PROFIMESH  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220045
• Other study ID #: 2023.226
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: January 2024
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: Frank Fernández, Dr.
• Phone: 972 94 02 60
• Email: cirurgia.girona.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Communicable Diseases
• Hernia
• Hernia Incisional
• Incisional Hernia
• Infections
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
Spain	Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 postoperative days
Secondary	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.	One year surgery
Secondary	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.	90 postoperative days