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Robotic Versus Open Ventral Hernia Repair (ROVHR)

Primary Purpose

Ventral Hernia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ventral Hernia Repair
Sponsored by
Lucas Beffa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring Robotic, Hernia, Ventral hernia, Open hernia, Mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years and older
  • 7 cm to 15 cm wide hernia midline defects
  • BMI less than or equal to 45
  • Patient deemed both an open and robotic candidate by operating surgeon

Exclusion Criteria:

  • 17 years old or younger
  • prisoners
  • pregnant patients
  • Emergent patients
  • BMI greater than 45
  • Hernia defects less than 7 cm or greater than 15 cm in width

Sites / Locations

  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open Ventral Hernia Repair

Robotic Ventral Hernia Repair

Arm Description

These patients will undergo open retromuscular ventral hernia repairs

These patients will undergo robotic retromuscular ventral hernia repairs.

Outcomes

Primary Outcome Measures

Length of Stay
Time in the hospital after the surgery

Secondary Outcome Measures

Post-operative wound complications
any abnormal wound healing
Other post operative complications
Heart attacks, acute kidney injury, admissions to ICU, respiratory failure
Readmission rate
Readmission to the hospital within 30 days of the surgery
Opioid consumption
Opioid prescribed and consumed
Acute pain scores
Numeric Rating Scale-11 pain scores daily, 0-10 with 0 being no pain and 10 being the worst pain for first five days after surgery
Hernia Related Specific Quality of Life Score
Score of 0-100 with lower scores indicating worse quality of life
Direct cost
Cost to the hospital
Hernia recurrence
Hernia recurrence
Quality of life scores using European Hernia Society (EuraHS) scale
EuraHS is a hernia specific quality of life scale with three domains: pain, restrictions of activity, and cosmesis. 0-30 with higher scores indicating a worse quality of life.

Full Information

First Posted
July 20, 2022
Last Updated
August 24, 2023
Sponsor
Lucas Beffa
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1. Study Identification

Unique Protocol Identification Number
NCT05472987
Brief Title
Robotic Versus Open Ventral Hernia Repair
Acronym
ROVHR
Official Title
Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lucas Beffa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.
Detailed Description
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair. This is a superiority trial with a primary outcome of length of stay in the hospital, theorizing that robotic retromuscular ventral hernia repairs are superior to open ventral hernia repairs by reducing length of stay by 24 hours. Patients will be blinded to the intervention, groups will be in parallel, and the primary outcome (when the patient is discharged) will be determined by a blinded assessor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
Robotic, Hernia, Ventral hernia, Open hernia, Mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Patients will be blinded to the intervention. The primary outcome will be determined by a surgeon other than the operating surgeon who is blinded to the intervention. Patients will also receive the same dressings over their wounds and an abdominal binder will be placed over the abdomen in attempts to limit the unblinding of the patient.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Ventral Hernia Repair
Arm Type
Active Comparator
Arm Description
These patients will undergo open retromuscular ventral hernia repairs
Arm Title
Robotic Ventral Hernia Repair
Arm Type
Active Comparator
Arm Description
These patients will undergo robotic retromuscular ventral hernia repairs.
Intervention Type
Procedure
Intervention Name(s)
Ventral Hernia Repair
Intervention Description
Patients will undergo retromuscular ventral hernia repair
Primary Outcome Measure Information:
Title
Length of Stay
Description
Time in the hospital after the surgery
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Post-operative wound complications
Description
any abnormal wound healing
Time Frame
30 day and one year
Title
Other post operative complications
Description
Heart attacks, acute kidney injury, admissions to ICU, respiratory failure
Time Frame
30 days
Title
Readmission rate
Description
Readmission to the hospital within 30 days of the surgery
Time Frame
30 days
Title
Opioid consumption
Description
Opioid prescribed and consumed
Time Frame
30 days and one year
Title
Acute pain scores
Description
Numeric Rating Scale-11 pain scores daily, 0-10 with 0 being no pain and 10 being the worst pain for first five days after surgery
Time Frame
5 days after surgery
Title
Hernia Related Specific Quality of Life Score
Description
Score of 0-100 with lower scores indicating worse quality of life
Time Frame
30 days and one year
Title
Direct cost
Description
Cost to the hospital
Time Frame
30 days
Title
Hernia recurrence
Description
Hernia recurrence
Time Frame
30 days and one year
Title
Quality of life scores using European Hernia Society (EuraHS) scale
Description
EuraHS is a hernia specific quality of life scale with three domains: pain, restrictions of activity, and cosmesis. 0-30 with higher scores indicating a worse quality of life.
Time Frame
30 day and one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years and older 7 cm to 15 cm wide hernia midline defects BMI less than or equal to 45 Patient deemed both an open and robotic candidate by operating surgeon Exclusion Criteria: 17 years old or younger prisoners pregnant patients Emergent patients BMI greater than 45 Hernia defects less than 7 cm or greater than 15 cm in width
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas Beffa, MD
Phone
216-445-5975
Email
beffal@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Ellis
Email
ellisr2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas Beffa, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Beffa, MD
Phone
216-445-5975
Email
Beffal@ccf.org
First Name & Middle Initial & Last Name & Degree
Ryan Ellis
Email
ellisr2@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Robotic Versus Open Ventral Hernia Repair

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