Robotic Versus Open Ventral Hernia Repair (ROVHR)

Lucas Beffa

Status: Enrolling

Conditions: Ventral Hernia

Treatments: Procedure: Ventral Hernia Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05472987

22-591

Details and patient eligibility

About

This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Open Ventral Hernia Repair

Active Comparator group

Description:

These patients will undergo open retromuscular ventral hernia repairs

Treatment:

Procedure: Ventral Hernia Repair

Robotic Ventral Hernia Repair

Active Comparator group

Description:

These patients will undergo robotic retromuscular ventral hernia repairs.

Treatment:

Procedure: Ventral Hernia Repair