Your session is about to expire
← Back to Search
Open Surgery
Robotic vs Open Surgery for Ventral Hernia (ROVHR Trial)
N/A
Recruiting
Led By Lucas Beffa, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years and older
7 cm to 15 cm wide hernia midline defects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
ROVHR Trial Summary
This trial is comparing two ways to do a retromuscular ventral hernia repair - one open and one robotic.
Who is the study for?
This trial is for adults with a body mass index (BMI) of 45 or less who have ventral hernias measuring between 7 and 15 cm wide. Candidates must be suitable for both open and robotic surgery as determined by the surgeon. It excludes prisoners, emergency cases, individuals with BMI over 45, hernia sizes outside the specified range, those under age 18, and pregnant women.Check my eligibility
What is being tested?
The study is examining two methods of repairing ventral hernias: traditional open retromuscular repair versus a robotic-assisted approach. Participants will be randomly assigned to one of these surgical techniques to compare outcomes.See study design
What are the potential side effects?
Potential side effects from either type of surgery may include pain at the incision site, infection risk, bleeding complications, possible injury to surrounding tissues or organs during the procedure, and general risks associated with anesthesia.
ROVHR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My hernia is between 7 cm and 15 cm wide.
ROVHR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of Stay
Secondary outcome measures
Acute pain scores
Direct cost
Hernia Related Specific Quality of Life Score
+6 moreROVHR Trial Design
2Treatment groups
Active Control
Group I: Open Ventral Hernia RepairActive Control1 Intervention
These patients will undergo open retromuscular ventral hernia repairs
Group II: Robotic Ventral Hernia RepairActive Control1 Intervention
These patients will undergo robotic retromuscular ventral hernia repairs.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,021 Previous Clinical Trials
1,365,530 Total Patients Enrolled
Lucas BeffaLead Sponsor
Lucas Beffa, MDPrincipal InvestigatorThe Cleveland Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgeon says I can have surgery either by hand or with a robot.I am 18 years old or older.I am 17 years old or younger.My BMI is over 45.My hernia is either smaller than 7 cm or larger than 15 cm wide.My hernia is between 7 cm and 15 cm wide.My hernia is between 7 cm and 15 cm wide.I am 18 years old or older.You have a body mass index (BMI) of less than or equal to 45.My surgeon says I can have surgery either by hand or with a robot.
Research Study Groups:
This trial has the following groups:- Group 1: Open Ventral Hernia Repair
- Group 2: Robotic Ventral Hernia Repair
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Ventral Hernia Patient Testimony for trial: Trial Name: NCT05472987 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation currently accepting participants?
"Per the data listed on clinicaltrials.gov, this medical trial is still searching for participants to join. The study was first advertised in July of 2022 and experienced its most recent update a month later in August."
Answered by AI
What is the upper limit for enrollment in this clinical trial?
"Correct. According to the details found on clinicaltrials.gov, this trial is in its active recruitment phase and was initially posted on July 25th 2022 with its last update occurring August 18th 2022. The study requires 200 participants at a single site for completion."
Answered by AI
Who else is applying?
What state do they live in?
California
Virginia
What site did they apply to?
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
If it is a trial do you still charge my insurance, What fees am I responsible for? Any compensation?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
My hernia issues. I am at the end of my rope and this time the hernia is protruding way to much to have a life.
PatientReceived 1 prior treatment
Recent research and studies
Share this study with friends
Copy Link
Messenger