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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06251583

Acronym

INDURATE

Enrollment

124

Registered

2024-02-09

Start date

2023-03-22

Completion date

2025-06-30

Last updated

2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehiscence Wound, Incisional Hernia of Anterior Abdominal Wall, Wound Infection

Brief 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.

Interventions

DEVICEduramesh suture

Duramesh-suture will be used for trocar closure in the experimental group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026