Clinical Trials Directory

Trials / Unknown

UnknownNCT03953365

Prophylactic Mesh in Cytoreductive Surgery

Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
66 (estimated)
Sponsor
Hospital Universitario Fundación Alcorcón · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREProphylactic MeshProphylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Timeline

Start date
2019-06-01
Primary completion
2021-05-31
Completion
2023-12-31
First posted
2019-05-16
Last updated
2019-05-16

Source: ClinicalTrials.gov record NCT03953365. Inclusion in this directory is not an endorsement.