What side effects are associated with this type of intervention?

The most common side effects of open retromuscular ventral hernia repair include a higher risk of surgical site infections, longer hospital stays, and postoperative pain. Robotic retromuscular ventral hernia repair, while associated with higher hospital costs and longer operative times, tends to result in shorter hospital stays and potentially improved fascial closure, which can reduce bulging and improve patient-reported outcomes. Both techniques have comparable recurrence rates, but robotic repair may offer advantages in terms of reduced postoperative complications and faster recovery times.

What prior FDA approvals exist?

The treatment of ventral hernias, particularly through surgical techniques such as open retromuscular and robotic retromuscular repairs, does not typically involve FDA-approved drugs but rather focuses on surgical methods and materials. Synthetic meshes, which are commonly used in these procedures, have received FDA clearance for use in hernia repairs. These meshes provide structural support to the weakened area and help prevent recurrence. The FDA has approved various types of synthetic meshes, including those made from polypropylene and other materials, for use in both open and minimally invasive hernia repair surgeries.

What other types of research exist?

Promising novel alternatives to Open and Robotic Retromuscular Ventral Hernia Repair include the extended view totally extraperitoneal (eTEP) approach and the retrorectus with transversus abdominis release (TAR) technique. The eTEP approach allows for dissection of the retrorectus space without entering the peritoneal cavity, potentially reducing complications. The TAR technique extends the retrorectus approach by releasing the posterior rectus sheath, allowing for closure of larger defects. Both techniques can be performed robotically or laparoscopically, offering flexibility and potentially improved outcomes.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

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 more

Awards & 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.

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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.