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

N/ARecruitingNCT06220045

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Colorectal Cancer Wound Infection Hernia Incisional

Interventions

Polyvinylidene fluoride meshCOMBINATION_PRODUCT

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

Prophylactic polypropylene meshCOMBINATION_PRODUCT

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

Secondary Outcomes

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