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

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

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

• Status: Recruiting
• Conditions: Wound Infection; Dehiscence Wound; Incisional Hernia of Anterior Abdominal Wall
• Intervention / Treatment: Device: duramesh suture

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28022
    • Recruiting
    • Miguel Ángel García Ureña
    • Contact: Ana Sánchez Gollarte, MD; Phone Number: 651690526; Email: asgollarte@gmail.com
    • Principal Investigator: Ana Sánchez Gollarte, MD
    • Sub-Investigator: Almudena Moreno Elola-Olaso, PhD
    • Sub-Investigator: Arturo Cruz Cidoncha, PhD
    • Sub-Investigator: Armando Galván Pérez, PhD
    • Sub-Investigator: Alvaro Robin Valle de Lersundi, PhD
    • Sub-Investigator: Victor Vaello Jodra, MD
    • Sub-Investigator: Carlos Guijarro Moreno, MD
    • Sub-Investigator: Clara María Martínez Moreno, MD
    • Sub-Investigator: Marina Pérez-Flecha González, MD
    • Sub-Investigator: Ana Maria Minaya Bravo, MD
    • Sub-Investigator: Enrique González González, PhD
    • Sub-Investigator: Patricia López Quindós, MD
    • Sub-Investigator: Asunción Aguilera Velardo, MD
    • Principal Investigator: Miguel Ángel García Ureña, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group or Duramesh group; Umbilical trocar closure using Suture-mesh (Duramesh suture).	Device: duramesh suture; Duramesh-suture will be used for trocar closure in the experimental group
Active Comparator: Control group or poli(4)hidroxibutirate group; Umbilical trocar closure using conventional monofilament suture.	Device: duramesh suture; Duramesh-suture will be used for trocar closure in the experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the umbilical trocar site hernia in each group	Evaluation of the incidence of umbilical trocar site hernia in duramesh group compared with the control group	12 monts

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infectious complications of the wound	Evaluation of the infectious complications related to umbilical wound after laparoscopic surgery. Compare the incidence of these complications in each group	12 months
Seroma and hematoma	Evaluation of the seroma and hematoma related to umbilical wound after laparoscopic surgery. Compare the incidence of these complications in each group	12 months
Intraabdominal events	Evaluation of intraabdominal events (fluid collections, bleeding, peritonitis...) and compare the incidence in each group.	12 months
Skin dehiscence and/or necrosis	Evaluate the incidence of skin complications in each group.	12 months
Early aponeurotic failure (evisceration)	Evaluation of early aponeurotic failure after laparoscopic procuderes and compare the incidence between the two different groups.	12 months

Collaborators and Investigators

• Sponsor: Miguel A ngel Garci-a Urena
• Collaborators: Ana Sánchez Gollarte; Álvaro Robin Valle de Lersundi; Arturo Cruz Cidoncha; Almudena Moreno Elola-Olaso; Armando Galván Pérez; Ana María Minaya Bravo; Enrique González González; Carlos Guijarro Moreno; Asunción Aguilera Velardo; Patricia López Quindos; Clara María Martínez Moreno; Marina Pérez-Flecha González; Victor Vaello Jodra

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Estimated): March 22, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Estimated): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Wounds and Injuries; Hernia, Ventral; Wound Infection; Incisional Hernia
• Other Study ID Numbers: INDURATE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes