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Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh

Primary Purpose

Umbilical Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enform Mesh
Marlex
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Umbilical Hernia focused on measuring Randomized Controlled Trial (RCT), Absorbable Mesh, Non-Absorbable Mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 years and older Primary umbilical hernia repair (UHR) [as defined by European Hernia Society (EHS) guidelines primary midline abdominal wall defect from 3 cm above to 3 cm below the umbilicus] Undergoing elective laparoscopic or open repair Defect size of 1-4cm2 Centers for Disease Control and Prevention (CDC) class 1 & 2 wounds Exclusion Criteria: None

Sites / Locations

  • Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-Absorbable Synthetic Mesh

Absorbable Synthetic Mesh

Arm Description

Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh.

Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh.

Outcomes

Primary Outcome Measures

Umbilical Hernia Recurrence
The rate of hernia recurrence 3-years postoperatively

Secondary Outcome Measures

Mesh Related Complication - Mesh infection
The rate of mesh infection within 1-year postoperatively
Mesh Related Complication - Mesh excision
The rate of mesh excision within 1-year postoperatively
Postoperative Outcome - 30-day readmission
The rate of 30-day readmission
Postoperative Outcome - Seroma
The rate seroma within 3-years postoperatively
Postoperative Outcome - Hematoma
The rate of hematoma within 3-years postoperatively
Postoperative Outcomes - Intra-abdominal abscess
The rate of intra-abdominal abscess within 3-years postoperatively
Postoperative Outcome - Wound cellulitis
The rate of wound cellulitis within 3-years postoperatively
Postoperative Outcome - Wound infection
The rate of wound infection within 3-years postoperatively
Postoperative Outcome - Superficial wound breakdown
The rate of superficial wound breakdown within 3-years postoperatively
Postoperative Outcomes - Mortality
The rate of mortality within 3-years postoperatively
Postoperative Outcomes - Length of stay
The length of stay (LOS) in the hospital postoperatively
Quality of Life (QOL)
QOL within 3-years of surgery as measured by the Carolinas Comfort Scale (CCS), a validated hernia specific QOL questionnaire. The CCS has 23 questions across 3 domains (mesh sensation, pain, and movement) that are scored 0-5 and N/A. Higher scores indicate worse symptoms. A score of 2 or more in any category is considered "symptomatic"; a score of 0 or 1 is considered "asymptomatic". Data will be reported as the frequency and percentage of "symptomatic" or "asymptomatic" for each of the 3 domains.

Full Information

First Posted
August 8, 2023
Last Updated
August 8, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05994248
Brief Title
Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh
Official Title
Absorbable and Synthetic Mesh: A Multicenter, Prospective, Non-Inferior, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
June 2029 (Anticipated)
Study Completion Date
June 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to see which of two types of mesh is better for fixing an umbilical hernia. One type of mesh is an absorbable synthetic mesh, which goes away on its own in the body, and the other type of mesh is a non-absorbable mesh, which stays in the body forever. The researchers will check if the hernia comes back, how it affects the patient's quality of life, and if there are any problems after the surgery during a three-year period.
Detailed Description
The goal of this study is to compare the use of absorbable synthetic (AS) mesh versus non-absorbable mesh (NAS) mesh to determine the 3-year recurrence, quality of life (QOL) and postoperative complications in umbilical hernia repair. Patients will be randomized into one of two arms to receive an absorbable (Enform) mesh or non-absorbable (Marlex) mesh. Patients will undergo an umbilical hernia repair with the mesh assigned to their randomization cohort. The hernia recurrence, quality of life and postoperative outcomes to determine if the two meshes are non-inferior.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Hernia
Keywords
Randomized Controlled Trial (RCT), Absorbable Mesh, Non-Absorbable Mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-Absorbable Synthetic Mesh
Arm Type
Experimental
Arm Description
Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh.
Arm Title
Absorbable Synthetic Mesh
Arm Type
Active Comparator
Arm Description
Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh.
Intervention Type
Device
Intervention Name(s)
Enform Mesh
Intervention Description
Use of absorbable mesh in umbilical hernia repair
Intervention Type
Device
Intervention Name(s)
Marlex
Intervention Description
Use of non-absorbable mesh in umbilical hernia repair
Primary Outcome Measure Information:
Title
Umbilical Hernia Recurrence
Description
The rate of hernia recurrence 3-years postoperatively
Time Frame
3-years postoperatively
Secondary Outcome Measure Information:
Title
Mesh Related Complication - Mesh infection
Description
The rate of mesh infection within 1-year postoperatively
Time Frame
1-year postoperatively
Title
Mesh Related Complication - Mesh excision
Description
The rate of mesh excision within 1-year postoperatively
Time Frame
1-year postoperatively
Title
Postoperative Outcome - 30-day readmission
Description
The rate of 30-day readmission
Time Frame
30-days postoperatively
Title
Postoperative Outcome - Seroma
Description
The rate seroma within 3-years postoperatively
Time Frame
3-years postoperatively
Title
Postoperative Outcome - Hematoma
Description
The rate of hematoma within 3-years postoperatively
Time Frame
3-years postoperatively
Title
Postoperative Outcomes - Intra-abdominal abscess
Description
The rate of intra-abdominal abscess within 3-years postoperatively
Time Frame
3-years postoperatively
Title
Postoperative Outcome - Wound cellulitis
Description
The rate of wound cellulitis within 3-years postoperatively
Time Frame
3-years postoperatively
Title
Postoperative Outcome - Wound infection
Description
The rate of wound infection within 3-years postoperatively
Time Frame
3-years postoperatively
Title
Postoperative Outcome - Superficial wound breakdown
Description
The rate of superficial wound breakdown within 3-years postoperatively
Time Frame
3-years postoperatively
Title
Postoperative Outcomes - Mortality
Description
The rate of mortality within 3-years postoperatively
Time Frame
3-years postoperatively
Title
Postoperative Outcomes - Length of stay
Description
The length of stay (LOS) in the hospital postoperatively
Time Frame
3-years postoperatively
Title
Quality of Life (QOL)
Description
QOL within 3-years of surgery as measured by the Carolinas Comfort Scale (CCS), a validated hernia specific QOL questionnaire. The CCS has 23 questions across 3 domains (mesh sensation, pain, and movement) that are scored 0-5 and N/A. Higher scores indicate worse symptoms. A score of 2 or more in any category is considered "symptomatic"; a score of 0 or 1 is considered "asymptomatic". Data will be reported as the frequency and percentage of "symptomatic" or "asymptomatic" for each of the 3 domains.
Time Frame
3-years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and older Primary umbilical hernia repair (UHR) [as defined by European Hernia Society (EHS) guidelines primary midline abdominal wall defect from 3 cm above to 3 cm below the umbilicus] Undergoing elective laparoscopic or open repair Defect size of 1-4cm2 Centers for Disease Control and Prevention (CDC) class 1 & 2 wounds Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Heniford, MD
Phone
704-355-3168
Email
Todd.Heniford@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Greg Scarola, MS
Phone
704-355-5766
Email
Gregory.Scarola@AtriumHealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Heniford, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Heniford, MD
Phone
704-355-3168
Email
Todd.Heniford@gmail.com
First Name & Middle Initial & Last Name & Degree
Greg Scarola, MS
Phone
704-355-5766
Email
Gregory.Scarola@AtriumHealth.org
First Name & Middle Initial & Last Name & Degree
Todd Heniford, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be made available to other researchers.

Learn more about this trial

Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh

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