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Prophylactic Mesh in Cytoreductive Surgery

Primary Purpose

Incisional Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prophylactic Mesh
Sponsored by
Hospital Universitario Fundación Alcorcón
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional Hernia focused on measuring hyperthermic intraperitoneal chemotherapy, cytoreduction surgery, prophylactic mesh

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Other

    Arm Label

    without mesh

    with mesh

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Rate of Incisional Hernia
    Prevention of Incisional Hernia

    Secondary Outcome Measures

    Full Information

    First Posted
    May 14, 2019
    Last Updated
    May 15, 2019
    Sponsor
    Hospital Universitario Fundación Alcorcón
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03953365
    Brief Title
    Prophylactic Mesh in Cytoreductive Surgery
    Official Title
    Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2019 (Anticipated)
    Primary Completion Date
    May 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitario Fundación Alcorcón

    4. Oversight

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

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Incisional Hernia
    Keywords
    hyperthermic intraperitoneal chemotherapy, cytoreduction surgery, prophylactic mesh

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    without mesh
    Arm Type
    No Intervention
    Arm Description
    Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy without prophylactic mesh
    Arm Title
    with mesh
    Arm Type
    Other
    Arm Description
    Patients undergo to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with prophylactic mesh
    Intervention Type
    Procedure
    Intervention Name(s)
    Prophylactic Mesh
    Intervention Description
    Prophylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
    Primary Outcome Measure Information:
    Title
    Rate of Incisional Hernia
    Description
    Prevention of Incisional Hernia
    Time Frame
    four years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Prophylactic Mesh in Cytoreductive Surgery

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