Robotic Versus Open Ventral Hernia Repair

NCT ID: NCT05472987

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-25

Study Completion Date

2027-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Patients will be blinded to the intervention. The primary outcome will be determined by a surgeon other than the operating surgeon who is blinded to the intervention. Patients will also receive the same dressings over their wounds and an abdominal binder will be placed over the abdomen in attempts to limit the unblinding of the patient.

Study Groups

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Open Ventral Hernia Repair

These patients will undergo open retromuscular ventral hernia repairs

Group Type ACTIVE_COMPARATOR

Ventral Hernia Repair

Intervention Type PROCEDURE

Patients will undergo retromuscular ventral hernia repair

Robotic Ventral Hernia Repair

These patients will undergo robotic retromuscular ventral hernia repairs.

Group Type ACTIVE_COMPARATOR

Ventral Hernia Repair

Intervention Type PROCEDURE

Patients will undergo retromuscular ventral hernia repair

Interventions

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Ventral Hernia Repair

Patients will undergo retromuscular ventral hernia repair

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lucas Beffa

OTHER

Sponsor Role lead

Responsible Party

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Lucas Beffa

Assistant Professor of Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lucas Beffa, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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University of Florida Health

Gainesville, Florida, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status RECRUITING

University of Tennessee Medical Center, Knoxville

Knoxville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lucas Beffa, MD

Role: CONTACT

216-445-5975

Alvaro Carvalho

Role: CONTACT

Facility Contacts

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Mazen Al-Mansour, MBBS

Role: primary

Lucas Beffa, MD

Role: primary

216-445-5975

Abby Birrell

Role: primary

864-522-2100

Kaela Blake, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40035894 (View on PubMed)

Other Identifiers

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22-591

Identifier Type: -

Identifier Source: org_study_id

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