Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site.

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Description

Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs.

The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias.

INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.

Study Overview

Start Date
March 22, 2023
Completion Date
June 30, 2025
Enrollment
124
Date Posted
February 9, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Miguel Ángel García Ureña
Madrid 28022, Spain

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Adults (at least 18 year-old patients)
Umbilical trocar incision > 10 mm
Any of the following risk factors: BMI > 27, Absence of primary umbilical hernia or smaller than 1 cm, active smoking, malnutrition, anemia, oncological surgery, diabetes, heart failure, chronic kidney disease, chronic liver disease, collagen disease, chronic pulmonary disease.

Exclusion Criteria:

Umbilical trocar incision < 10 mm
Umbilical hernia > 10 mm
Hernia surgery or incisional hernia at the trocar site
Conversion to laparotomy
Pregnancy
Ascites or cirrhosis
Clasification of the American Anestesiology Classification IV o V.
Inadequate follow-up
Patients included in any other trial
Patients with life expectancy < 12 months
Patients with any kind of sensibility to Duramesh

Study Contact Info

Study Contact Name
Ana Sánchez Gollarte, MD; Almudena Moreno Elola-Olaso, PhD; Arturo Cruz Cidoncha, PhD; Armando Galván Pérez, PhD; Alvaro Robin Valle de Lersundi, PhD; Victor Vaello Jodra, MD; Carlos Guijarro Moreno, MD; Clara María Martínez Moreno, MD; Marina Pérez-Flecha González, MD; Ana Maria Minaya Bravo, MD; Enrique González González, PhD; Patricia López Quindós, MD; Asunción Aguilera Velardo, MD; Miguel Ángel García Ureña, PhD
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
NCTid (if applicable)
NCT06251583