Prophylactic Mesh in Cytoreductive Surgery
Not Applicable
- Conditions
- Incisional Hernia
- Interventions
- Procedure: Prophylactic Mesh
- Registration Number
- NCT03953365
- Lead Sponsor
- Hospital Universitario Fundación Alcorcón
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 66
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description with mesh Prophylactic Mesh Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with prophylactic mesh
- Primary Outcome Measures
Name Time Method Rate of Incisional Hernia four years Prevention of Incisional Hernia
- Secondary Outcome Measures
Name Time Method