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
About this trial
This is an interventional prevention trial for Incisional Hernia focused on measuring hyperthermic intraperitoneal chemotherapy, cytoreduction surgery, prophylactic mesh
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
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
NCT ID
NCT03953365
First Posted
May 14, 2019
Last Updated
May 15, 2019
Sponsor
Hospital Universitario Fundación Alcorcón
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
Learn more about this trial
Prophylactic Mesh in Cytoreductive Surgery
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