This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Patients will undergo retromuscular ventral hernia repair
University of Florida Health
Gainesville, Florida, United States
RECRUITINGUniversity Hospitals
Cleveland, Ohio, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
Length of Stay
Time in the hospital after the surgery
Time frame: 30 days
Post-operative wound complications
any abnormal wound healing
Time frame: 30 day and one year
Other post operative complications
Heart attacks, acute kidney injury, admissions to ICU, respiratory failure
Time frame: 30 days
Readmission rate
Readmission to the hospital within 30 days of the surgery
Time frame: 30 days
Opioid consumption
Opioid prescribed and consumed
Time frame: 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
Time frame: 5 days after surgery
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
Direct cost
Cost to the hospital
Time frame: 30 days
Hernia recurrence
Hernia recurrence
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
RECRUITINGUniversity of Tennessee Medical Center, Knoxville
Knoxville, Tennessee, United States
RECRUITINGTime frame: 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.
Time frame: 30 day and one year