Prophylactic Mesh in Cytoreductive Surgery

May 15, 2019 updated by: Federico Ochando, Hospital Universitario Fundación Alcorcón

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: without mesh
Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy without prophylactic mesh
Other: with mesh
Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with prophylactic mesh
Procedure: Prophylactic Mesh
Prophylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Incisional Hernia
Time Frame: four years
Prevention of Incisional Hernia
four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Fundación Alcorcón

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 14, 2019

First Submitted That Met QC Criteria

May 15, 2019

First Posted (Actual)

May 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 19/41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Incisional Hernia

Clinical Trials on Prophylactic Mesh

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe