Ventral Hernia
Conditions
Keywords
Robotic, Hernia, Ventral hernia, Open hernia, Mesh
Brief summary
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular 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.
Interventions
PROCEDUREVentral Hernia Repair
Patients will undergo retromuscular ventral hernia repair
Sponsors
Lucas Beffa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | 30 days | Time in the hospital after the surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative wound complications | 30 day and one year | any abnormal wound healing |
| Other post operative complications | 30 days | Heart attacks, acute kidney injury, admissions to ICU, respiratory failure |
| Readmission rate | 30 days | Readmission to the hospital within 30 days of the surgery |
| Opioid consumption | 30 days and one year | Opioid prescribed and consumed |
| 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 |
| Hernia Related Specific Quality of Life Score | 30 days and one year | Score of 0-100 with lower scores indicating worse quality of life |
| Direct cost | 30 days | Cost to the hospital |
| 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. |
| Hernia recurrence | 30 days and one year | Hernia recurrence |
Countries
United States
Contacts
CONTACTLucas Beffa, MD
CONTACTRiley Wilkinson, MD
PRINCIPAL_INVESTIGATORLucas Beffa, MD
The Cleveland Clinic
Outcome results
None listed