Robotic Versus Open Ventral Hernia Repair

Study Overview
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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.

Official Title
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Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial

Conditions
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Ventral Hernia

Intervention / Treatment
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* Procedure: Ventral Hernia Repair


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Ventral Hernia Repair<br>These patients will undergo open retromuscular ventral hernia repairs | Procedure: Ventral Hernia Repair<br>* Patients will undergo retromuscular ventral hernia repair<br>|
| Active Comparator: Robotic Ventral Hernia Repair<br>These patients will undergo robotic retromuscular ventral hernia repairs. | Procedure: Ventral Hernia Repair<br>* Patients will undergo retromuscular ventral hernia repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Time in the hospital after the surgery | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative wound complications | any abnormal wound healing | 30 day and one year | 
| Other post operative complications | Heart attacks, acute kidney injury, admissions to ICU, respiratory failure | 30 days | 
| Readmission rate | Readmission to the hospital within 30 days of the surgery | 30 days | 
| Opioid consumption | Opioid prescribed and consumed | 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 | 5 days after surgery | 
| Hernia Related Specific Quality of Life Score | Score of 0-100 with lower scores indicating worse quality of life | 30 days and one year | 
| Direct cost | Cost to the hospital | 30 days | 
| Hernia recurrence | Hernia recurrence | 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. | 30 day and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic, Hernia, Ventral hernia, Open hernia, Mesh