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

Last updated: February 1, 2024
Sponsor: Miguel A ngel Garci-a Urena
Overall Status: Active - Recruiting

Phase

3

Condition

Hernia

Treatment

duramesh suture

Clinical Study ID

NCT06251583
INDURATE
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 orsmaller than 1 cm, active smoking, malnutrition, anemia, oncological surgery,diabetes, heart failure, chronic kidney disease, chronic liver disease, collagendisease, chronic pulmonary disease.

Exclusion

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 Design

Total Participants: 124
Treatment Group(s): 1
Primary Treatment: duramesh suture
Phase: 3
Study Start date:
March 22, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Miguel Ángel García Ureña

    Madrid, 28022
    Spain

    Active - Recruiting

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