Incisional Hernia
Conditions
Keywords
hyperthermic intraperitoneal chemotherapy, cytoreduction surgery, prophylactic mesh
Brief summary
Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.
Detailed description
Based on the hypothesis that oncological cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) is associated with an increased risk of developing Incisional Hernia in the postoperative period, with an expected incidence of 50% at 24 months, we designed a prospective, multicenter and randomized clinical study to demonstrate the utility of the meshes in the prevention of Incisional Hernia, hoping to reduce the incidence to 15% at 24 months.
Interventions
PROCEDUREProphylactic Mesh
Prophylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Sponsors
Hospital Universitario Fundación Alcorcón
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Completeness of cytoreduction after surgery (CC-SCORE) CC-0, CC-1
Exclusion criteria
* Completeness of cytoreduction after surgery (CC-SCORE) CC-2, CC-3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Incisional Hernia | four years | Prevention of Incisional Hernia |
Outcome results
None listed