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

Phase 3

Recruiting

• Conditions: Dehiscence Wound; Incisional Hernia of Anterior Abdominal Wall; Wound Infection
• Interventions: Device: duramesh suture

• Registration Number: NCT06251583
• Lead Sponsor: Miguel A ngel Garci-a Urena

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-22
• Status Verified: 2024-02
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-03-22
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group or Duramesh group	duramesh suture	Umbilical trocar closure using Suture-mesh (Duramesh suture).
Control group or poli(4)hidroxibutirate group	duramesh suture	Umbilical trocar closure using conventional monofilament suture.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Miguel Ángel García Ureña; 🇪🇸 Madrid, Spain