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

NCT06220045 | Recruiting

• 1 other identifier: 2023.226
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Wound Infection; Hernia Incisional

Keywords

Colorectal cancer; Wound Infection; Hernia Incisional; Mesh; Polypropylene; PVDF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of incisional hernia

  One year surgery

• Morbidity and mortality rates

  90 postoperative days

Study Arms (2)

Polyvinylidene fluoride mesh

EXPERIMENTAL

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

Prophylactic polypropylene mesh

EXPERIMENTAL

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

Interventions

Polyvinylidene fluoride mesh COMBINATION_PRODUCT

Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh.

Polyvinylidene fluoride mesh

Prophylactic polypropylene mesh COMBINATION_PRODUCT

Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.

Prophylactic polypropylene mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,

Girona, 17001, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Wound Infection; Incisional Hernia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Infections; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

Frank Fernández, Dr.

CONTACT

972 94 02 60; cirurgia.girona.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients meeting the inclusion criteria for the study will be randomized 1:1 using random number generation functions with SPSS v.21 software into either the PP or PVDF group. This randomization will be carried out using sealed opaque envelopes at the time immediately preceding the onset of the surgical intervention within the operating room. The envelope will be opened within the operating room once the closure of the midline laparotomy is initiated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: February 1, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)