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

Prevention of Incisional Hernia With Mesh-suture (Duramesh Suture) at Umbilical Trocar Site in Patients Who Undergo Laparoscopic Surgical Approach

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.

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