NCT03953365
Unknown
Not Applicable
Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial
Hospital Universitario Fundación Alcorcón0 sites66 target enrollmentJune 1, 2019
ConditionsIncisional Hernia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Incisional Hernia
- Sponsor
- Hospital Universitario Fundación Alcorcón
- Enrollment
- 66
- Primary Endpoint
- Rate of Incisional Hernia
- Last Updated
- 6 years ago
Overview
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.
Investigators
Federico Ochando
MEDICAL DOCTOR
Hospital Universitario Fundación Alcorcón
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of Incisional Hernia
Time Frame: four years
Prevention of Incisional Hernia
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