Robotic Versus Open Ventral Hernia Repair (ROVHR)

Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucas Beffa, MD; Phone Number: 216-445-5975; Email: Beffal@ccf.org
• Study Contact Backup: Name: Alvaro Carvalho; Email: Carvala3@ccf.org

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • University of Florida Health
      • Contact: Mazen Al-Mansour, MBBS
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Lucas Beffa, MD; Phone Number: 216-445-5975; Email: Beffal@ccf.org
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health Greenville Memorial Hospital
      • Principal Investigator: Jeremy Warren, MD
      • Contact: Abby Birrell; Phone Number: 864-522-2100; Email: abby.birrell@prismahealth.org
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center, Knoxville
      • Contact: Kaela Blake, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open Ventral Hernia Repair; These patients will undergo open retromuscular ventral hernia repairs	Procedure: Ventral Hernia Repair; Patients will undergo retromuscular ventral hernia repair
Active Comparator: Robotic Ventral Hernia Repair; These patients will undergo robotic retromuscular ventral hernia repairs.	Procedure: Ventral Hernia Repair; Patients will undergo retromuscular ventral hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Time in the hospital after the surgery	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative wound complications	any abnormal wound healing	30 day and one year
Other post operative complications	Heart attacks, acute kidney injury, admissions to ICU, respiratory failure	30 days
Readmission rate	Readmission to the hospital within 30 days of the surgery	30 days
Opioid consumption	Opioid prescribed and consumed	30 days and one year
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	5 days after surgery
Hernia Related Specific Quality of Life Score	Score of 0-100 with lower scores indicating worse quality of life	30 days and one year
Direct cost	Cost to the hospital	30 days
Hernia recurrence	Hernia recurrence	30 days and one year
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.	30 day and one year

Collaborators and Investigators

• Sponsor: Lucas Beffa
• Investigators: Principal Investigator: Lucas Beffa, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• Carvalho AC, Woo KP, Ellis RC, Tu C, Miller BT, Prabhu AS, Rosen MJ, Krpata DM, Petro CC, Beffa LR. Robotic versus open ventral hernia repair (ROVHR): a randomized controlled trial protocol. Hernia. 2025 Mar 4;29(1):109. doi: 10.1007/s10029-025-03299-7.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Ventral hernia; Robotic; Hernia; Mesh; Open hernia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia; Hernia, Ventral
• Other Study ID Numbers: 22-591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No