Prophylactic Mesh in Cytoreductive Surgery

Hospital Universitario Fundación Alcorcón

Status: Unknown

Conditions: Incisional Hernia

Treatments: Procedure: Prophylactic Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03953365

PI 19/41

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

without mesh

No Intervention group

Description:

Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy without prophylactic mesh

with mesh

Other group

Description:

Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with prophylactic mesh

Treatment:

Procedure: Prophylactic Mesh