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Clinical Trials in Spain / NCT06220045
Recruiting Not applicable

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

NCT06220045 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-02-01
Last updated
2024-10-08

Condition(s) studied

Colorectal CancerWound InfectionHernia Incisional

Investigational drug(s) / intervention(s)

Polyvinylidene fluoride meshProphylactic polypropylene mesh

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

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

More Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06220045 on ClinicalTrials.gov ↗ ← All trials in Spain