NCT06251583

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

February 1, 2024

Last Update Submit

February 1, 2024

Conditions

Incisional Hernia of Anterior Abdominal WallDehiscence WoundWound Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Infectious complications of the wound

    12 months

  • Seroma and hematoma

    12 months

  • Intraabdominal events

    12 months

  • Skin dehiscence and/or necrosis

    12 months

  • Early aponeurotic failure (evisceration)

    12 months

Study Arms (2)

Experimental group or Duramesh group

EXPERIMENTAL

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

Device: duramesh suture

Control group or poli(4)hidroxibutirate group

ACTIVE COMPARATOR

Umbilical trocar closure using conventional monofilament suture.

Device: duramesh suture

Interventions

duramesh sutureDEVICE

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

Control group or poli(4)hidroxibutirate groupExperimental group or Duramesh group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miguel Ángel García Ureña

Madrid, 28022, Spain

RECRUITING

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Miguel Ángel García Ureña

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

March 22, 2023

Primary Completion

March 22, 2024

Study Completion

June 30, 2025

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations

ES(1)