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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two types of surgeries for fixing abdominal wall hernias: traditional open surgery and robotic-assisted surgery. It aims to see if robotic surgery can shorten the hospital stay compared to open surgery. Patients with ventral hernias will undergo one of the two methods, and their recovery will be evaluated. Robotic-assisted surgery has been increasingly used in recent years for ventral hernia repair, combining minimally invasive techniques with retromuscular mesh placement.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Length of Stay
Secondary study objectives
Acute pain scores
Direct cost
Hernia Related Specific Quality of Life Score
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for ventral hernia, particularly open retromuscular repair and robotic retromuscular repair, work by repositioning the herniated tissue and reinforcing the abdominal wall with mesh. Open retromuscular repair involves a traditional surgical incision, while robotic retromuscular repair uses robotic assistance for enhanced precision through smaller incisions.
These methods are important for patients to understand as they offer different benefits in terms of recovery time, potential complications, and overall effectiveness, helping them make informed decisions about their treatment options.
Standardization and ten essential steps in the lateral robotic extended totally extraperitoneal (eTEP) repair of ventral hernias.Investigation of Financial Conflict of Interest among Published Ventral Hernia Research.
Standardization and ten essential steps in the lateral robotic extended totally extraperitoneal (eTEP) repair of ventral hernias.Investigation of Financial Conflict of Interest among Published Ventral Hernia Research.
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Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,056 Previous Clinical Trials
1,371,410 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.
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