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Clinical Trials in Spain / NCT03105895
Active, not recruiting Observational

Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

NCT03105895 · tracked via the Priya Life Science Spain tracker
Sponsor
Henares University Hospital
Phase
Observational
Started
2017-09-01
Last updated
2026-08-19

Condition(s) studied

Incisional Hernia

Investigational drug(s) / intervention(s)

Mesh group

Mesh group: An onlay PDVF mesh will be placed as abdominal wall reinforcement

Study summary

It has been demonstrated that incisional hernia incidence after laparotomy can be safely reduced with the addition of a mesh to the conventional closure of the abdominal wall. There still some debate about which is the best position to place this mesh: onlay or sublay. In Europe we have now meshes with CEE approval to be used as reinforcement of abdominal wall closure. The investigators have planned to include 200 patients in a multi center study using an onlay PDVF mesh that can be tracked by magnetic resonance. The patients included will be patients with risk factors for the development of an incisional hernia. The incidence of incisional hernia will be assessed clinically and radiologically after 1 and 2 years follow-up. The incidence of surgical sites occurrences and pain will be also assessed.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Any known risk factor for development of incisional hernia * \> 60 years * BMI \> 30 * DM * Chronic bronquitis * Smoking * Neoplasia * Renal failure * Liver failure * Immnusupression * Urgent or emergency operation Exclusion Criteria: * Previous supraumbilical midline laparotomy * Previous incisional hernia * Life expectancy of less than 12 months * Patient´s rejection to participate * Unable to understand and participate

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Sureste Hospital Arganda Madrid
San Agustín University Hospital Avilés Principality of Asturias
University Central Hospital of Asturias Oviedo Principality of Asturias
Nuestra Señora del Prado University Hospital Talavera de la Reina Toledo
Puerta de Hierro University Hospital Madrid 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 NCT03105895 on ClinicalTrials.gov ↗ ← All trials in Spain