Prophylactic Mesh in Cytoreductive Surgery

NCT ID: NCT03953365

Last Updated: 2019-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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

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Incisional Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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without mesh

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

Group Type NO_INTERVENTION

No interventions assigned to this group

with mesh

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

Group Type OTHER

Prophylactic Mesh

Intervention Type PROCEDURE

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

Interventions

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Prophylactic Mesh

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Fundación Alcorcón

OTHER

Sponsor Role lead

Responsible Party

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Federico Ochando

MEDICAL DOCTOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PI 19/41

Identifier Type: -

Identifier Source: org_study_id

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