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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Incisional Hernia of Anterior Abdominal Wall Dehiscence Wound Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group or Duramesh group

Umbilical trocar closure using Suture-mesh (Duramesh suture).

Group Type EXPERIMENTAL

duramesh suture

Intervention Type DEVICE

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

Control group or poli(4)hidroxibutirate group

Umbilical trocar closure using conventional monofilament suture.

Group Type ACTIVE_COMPARATOR

duramesh suture

Intervention Type DEVICE

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

Interventions

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duramesh suture

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No