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Prophylactic Mesh in Cytoreductive Surgery

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ClinicalTrials.gov Identifier: NCT03953365
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Federico Ochando, Hospital Universitario Fundación Alcorcón

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

Condition or disease Intervention/treatment Phase
Incisional Hernia Procedure: Prophylactic Mesh Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
No Intervention: without mesh
Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy without prophylactic mesh
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




Primary Outcome Measures :
  1. Rate of Incisional Hernia [ Time Frame: four years ]
    Prevention of Incisional Hernia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Federico Ochando, MEDICAL DOCTOR, Hospital Universitario Fundación Alcorcón
ClinicalTrials.gov Identifier: NCT03953365     History of Changes
Other Study ID Numbers: PI 19/41
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Federico Ochando, Hospital Universitario Fundación Alcorcón:
hyperthermic intraperitoneal chemotherapy
cytoreduction surgery
prophylactic mesh

Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes