ROVHR: Robotic Versus Open Ventral Hernia Repair

Sponsor
Lucas Beffa (Other)
Overall Status
Recruiting
CT.gov ID
NCT05472987
Collaborator
(none)
200
1
2
36.2
5.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ventral Hernia Repair
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial
Actual Study Start Date :
Jul 25, 2022
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Length of Stay [30 days]

    Time in the hospital after the surgery

Secondary Outcome Measures

  1. Post-operative wound complications [30 day and one year]

    any abnormal wound healing

  2. Other post operative complications [30 days]

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

  3. Readmission rate [30 days]

    Readmission to the hospital within 30 days of the surgery

  4. Opioid consumption [30 days and one year]

    Opioid prescribed and consumed

  5. Acute pain scores [5 days after surgery]

    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

  6. Hernia Related Specific Quality of Life Score [30 days and one year]

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

  7. Direct cost [30 days]

    Cost to the hospital

  8. Hernia recurrence [30 days and one year]

    Hernia recurrence

  9. Quality of life scores using European Hernia Society (EuraHS) scale [30 day and one year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Cleveland Ohio United States 44195

Sponsors and Collaborators

  • Lucas Beffa

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lucas Beffa, Assistant Professor of Surgery, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT05472987
Other Study ID Numbers:
  • 22-591
First Posted:
Jul 25, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lucas Beffa, Assistant Professor of Surgery, The Cleveland Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022