Prophylactic Mesh in Cytoreductive Surgery

Hospital Universitario Fundación Alcorcón66 enrolled

Overview

Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Incisional Hernia

Interventions

Prophylactic MeshPROCEDURE

Prophylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Prevention of Incisional Hernia

Time frame: four years

Data from ClinicalTrials.gov

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