Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site.
NCT06251583 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2024-02-09
Summary
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.
Conditions
- Incisional Hernia of Anterior Abdominal Wall
- Dehiscence Wound
- Wound Infection
Interventions
- DEVICE
-
duramesh suture
Duramesh-suture will be used for trocar closure in the experimental group
Sponsors & Collaborators
-
Ana Sánchez Gollarte
collaborator UNKNOWN -
Álvaro Robin Valle de Lersundi
collaborator UNKNOWN -
Arturo Cruz Cidoncha
collaborator UNKNOWN -
Almudena Moreno Elola-Olaso
collaborator UNKNOWN -
Armando Galván Pérez
collaborator UNKNOWN -
Ana María Minaya Bravo
collaborator UNKNOWN -
Enrique González González
collaborator UNKNOWN -
Carlos Guijarro Moreno
collaborator UNKNOWN -
Asunción Aguilera Velardo
collaborator UNKNOWN -
Patricia López Quindos
collaborator UNKNOWN -
Clara María Martínez Moreno
collaborator UNKNOWN -
Marina Pérez-Flecha González
collaborator UNKNOWN -
Victor Vaello Jodra
collaborator UNKNOWN -
Miguel A ngel Garci-a Urena
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-22
- Primary Completion
- 2024-03-22
- Completion
- 2025-06-30
- FDA Device
- Yes
Countries
- Spain
Study Locations
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