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

Wound Infection Clinical Trial

— INDURATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251583
• Other study ID #: INDURATE
• Status: Recruiting
• Phase: Phase 3
• Start date: March 22, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Henares University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: June 30, 2025
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Incisional Hernia of Anterior Abdominal Wall
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• duramesh suture
Duramesh-suture will be used for trocar closure in the experimental group

Locations

Country	Name	City	State
Spain	Miguel Ángel García Ureña	Madrid

Sponsors (14)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Intraabdominal events	Evaluation of intraabdominal events (fluid collections, bleeding, peritonitis...) and compare the incidence in each group.	12 months
Secondary	Skin dehiscence and/or necrosis	Evaluate the incidence of skin complications in each group.	12 months
Secondary	Early aponeurotic failure (evisceration)	Evaluation of early aponeurotic failure after laparoscopic procuderes and compare the incidence between the two different groups.	12 months