Prevention of Incisional Hernia With Mesh-suture (Duramesh Suture) at Umbilical Trocar Site in Patients Who Undergo Laparoscopic Surgical Approach

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Miguel Ángel García Ureña
RECRUITING
Madrid
Time Frame
Start Date: 2023-03-22
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 124
Treatments
Experimental: Experimental group or Duramesh group
Umbilical trocar closure using Suture-mesh (Duramesh suture).
Active_comparator: Control group or poli(4)hidroxibutirate group
Umbilical trocar closure using conventional monofilament suture.
Related Therapeutic Areas
Sponsors
Collaborators: Armando Galván Pérez, Ana María Minaya Bravo, Victor Vaello Jodra, Almudena Moreno Elola-Olaso, Enrique González González, Patricia López Quindos, Carlos Guijarro Moreno, Clara María Martínez Moreno, Arturo Cruz Cidoncha, Ana Sánchez Gollarte, Álvaro Robin Valle de Lersundi, Marina Pérez-Flecha González, Asunción Aguilera Velardo
Leads: Miguel A ngel Garci-a Urena

This content was sourced from clinicaltrials.gov