Clinical trial NCT06251583: Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site.
Official title: Prevention of Incisional Hernia With Mesh-suture (Duramesh Suture) at Umbilical Trocar Site in Patients Who Undergo Laparoscopic Surgical Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Incisional Hernia of Anterior Abdominal Wall
Dehiscence Wound
Wound Infection
Lead sponsor: Henares University Hospital
Sponsor class: OTHER
Collaborators: name: Ana Sánchez Gollarte
name: Álvaro Robin Valle de Lersundi
name: Arturo Cruz Cidoncha
name: Almudena Moreno Elola-Olaso
name: Armando Galván Pérez
name: Ana María Minaya Bravo
name: Enrique González González
name: Carlos Guijarro Moreno
name: Asunción Aguilera Velardo
name: Patricia López Quindos
name: Clara María Martínez Moreno
name: Marina Pérez-Flecha González
name: Victor Vaello Jodra
First posted: 2024-02-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of the umbilical trocar site hernia in each group
timeFrame: 12 monts
Secondary outcomes:
measure: Infectious complications of the wound
timeFrame: 12 months
measure: Seroma and hematoma
timeFrame: 12 months
measure: Intraabdominal events
timeFrame: 12 months
measure: Skin dehiscence and/or necrosis
timeFrame: 12 months
measure: Early aponeurotic failure (evisceration)
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Miguel Ángel García Ureña
Study officials:
References: