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

Launched by MIGUEL A NGEL GARCI-A URENA · Feb 1, 2024

Keywords

ClinConnect Summary

The INDURATE trial is studying a new approach to prevent incisional hernias that can occur at the umbilical trocar site after laparoscopic surgeries, which are minimally invasive procedures. An incisional hernia happens when tissue pushes through a weak spot in the abdominal wall, and it can happen in 20 to 35% of patients who have had this type of surgery. This trial will test whether using a special type of mesh that is stitched in place can be more effective at preventing these hernias compared to standard stitches alone.

To participate in this trial, you must be at least 18 years old and have a larger umbilical incision of more than 10 mm. Additionally, you should have certain risk factors, such as being overweight (with a BMI over 27), being a smoker, or having other health conditions like diabetes or heart disease. If you qualify and choose to participate, you will help researchers understand if this new method is better at preventing hernias and improving recovery after surgery. It's important to note that anyone with specific health issues or complications will not be eligible for the study.

Gender

ALL

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