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

Miguel A ngel Garci-a Urena

Status and phase: Enrolling; Phase 3

Conditions: Dehiscence Wound; Incisional Hernia of Anterior Abdominal Wall; Wound Infection

Treatments: Device: duramesh suture

Study type: Interventional

Funder types: Other

Identifiers

NCT06251583

INDURATE

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

Experimental group or Duramesh group

Experimental group

Description:

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

Treatment:

Device: duramesh suture

Control group or poli(4)hidroxibutirate group

Active Comparator group

Description:

Umbilical trocar closure using conventional monofilament suture.

Treatment:

Device: duramesh suture