ClinicalTrials.gg
RecruitingNCT05472987ROVHRUpdated Aug 14, 2026

Robotic Versus Open Ventral Hernia Repair

An interventional study of Ventral Hernia Repair in Ventral Hernia, sponsored by Lucas Beffa. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Lucas Beffa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Ventral Hernia

Keywords

  • Robotic
  • Hernia
  • Ventral hernia
  • Open hernia
  • Mesh
03

In context

Hernia, Ventral

230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.

This study's planned enrollment of 200 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.

Browse Hernia, Ventral studies →

Lead sponsor

This is the only study on the registry with Lucas Beffa as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years and older
  • 7 cm to 15 cm wide hernia midline defects
  • less than or equal to 45
  • Patient deemed both an open and robotic candidate by operating surgeon

Exclusion criteria

Exclusion Criteria:

  • 17 years old or younger
  • prisoners
  • pregnant patients
  • Emergent patients
  • greater than 45
  • Hernia defects less than 7 cm or greater than 15 cm in width
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Open Ventral Hernia Repair

    These patients will undergo open retromuscular ventral hernia repairs

    Procedure: Ventral Hernia Repair

  • Active comparator
    Robotic Ventral Hernia Repair

    These patients will undergo robotic retromuscular ventral hernia repairs.

    Procedure: Ventral Hernia Repair

Interventions

  • ProcedureVentral Hernia Repair

    Patients will undergo retromuscular ventral hernia repair

06

What researchers measure

Primary outcomes

  1. Length of Stay

    Time in the hospital after the surgery

    Time frame: 30 days

Secondary outcomes

  1. Post-operative wound complications

    any abnormal wound healing

    Time frame: 30 day and one year

  2. Other post operative complications

    Heart attacks, acute kidney injury, admissions to ICU, respiratory failure

    Time frame: 30 days

  3. Readmission rate

    Readmission to the hospital within 30 days of the surgery

    Time frame: 30 days

  4. Opioid consumption

    Opioid prescribed and consumed

    Time frame: 30 days and one year

  5. 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

    Time frame: 5 days after surgery

  6. Hernia Related Specific Quality of Life Score

    Score of 0-100 with lower scores indicating worse quality of life

    Time frame: 30 days and one year

  7. Direct cost

    Cost to the hospital

    Time frame: 30 days

  8. Hernia recurrence

    Hernia recurrence

    Time frame: 30 days and one year

  9. 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.

    Time frame: 30 day and one year

07

Study locations

5 of 5 sites recruiting
08

References and documents

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. PubMed 40035894 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2022 (actual). Primary completion is estimated for Aug 2027, 60 months after the start.

Of 75 non-industry interventional studies with no phase under Hernia, Ventral, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 60 months is above that.

Counting every sponsor, half of 88 studies reached it within 37 months; a quarter within 19 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2022
First posted
Jul 25, 2022
StartActual
Jul 25, 2022
Primary completionEst.
Aug 1, 2027
CompletionEst.
Aug 1, 2027
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05472987
Lead sponsor
Lucas Beffa
Responsible party
Lucas Beffa (Assistant Professor of Surgery, The Cleveland Clinic) — Sponsor-investigator
First posted
Jul 25, 2022
Start date
Jul 25, 2022
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Aug 14, 2026

Study contacts

Lucas Beffa, MD
Contact
beffal@ccf.org
216-445-5975
Riley Wilkinson, MD
Contact
wilkinr3@ccf.org
Lucas Beffa, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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