ORREO: Open Versus Robotic Retromuscular Ventral Hernia Repair
Study Details
Study Description
Brief Summary
The purpose of this study is to determine how the robotic retromuscular hernia repair compares to the open retromuscular hernia repair for large hernia defects in patients at higher risk of wound complications.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
All patients presenting to the Greenville Health System Hernia Center who meet the inclusion criteria will be considered for enrollment. Patients who qualify and agree to participate will be randomized 1:1 to robotic retromuscular ventral hernia repair or open retromuscular ventral hernia repair. Data to be collected includes the following: demographic information, medical characteristics, medications, medical and surgical history, operative details, hospital stay data, and patient-reported outcomes via a quality of life questionnaire. Post-operative follow-up will occur at 2 weeks, 6 weeks, 6 months, 1 year and 2 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: robotic ventral hernia repair (VHR) Robotic VHR |
Procedure: robotic ventral hernia repair
A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar mesh placement, and similar closure of the hernia defect. The surgical robot is a tool that allows your surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of your abdomen. Rather than one longer incision in the middle of your abdomen, four to six small incisions, about 1 inch, are made along the outer part of your abdomen between the rib cage and hip.
|
| Active Comparator: open ventral hernia repair (VHR) Open VHR |
Procedure: open ventral hernia repair
An open retromuscular ventral hernia repair involves an incision through your abdominal wall, most often through a prior surgery scar. The contents of the hernia, which may include intestine or fatty tissue, are returned into the abdominal cavity. The posterior (inner-most) layer of the abdominal wall is separated from the muscle and closed, which closes the abdominal cavity. Mesh is then placed over that closed layer, which is outside of the abdominal cavity, but below the abdominal muscles. The anterior (outer-most) layer of the abdominal wall is then closed over the mesh, which closes the hernia.
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Outcome Measures
Primary Outcome Measures
- Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence [Through study completion, an average of 2 years]
A composite outcome of events which are clinically significant including but not limited to seroma requiring procedural intervention, skin dehiscence, cellulitis, hematoma, skin necrosis, and surgical site infections which may require interventions such as wound care or antibiotic therapy.
Secondary Outcome Measures
- All surgical site occurrences [Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years]
- Surgical site occurrences requiring procedural intervention [Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years]
- All surgical site infections [Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years]
- Surgical site infections requiring procedural intervention [Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years]
- Length of stay at hospital measured in days [Time from procedure until discharge, an expected range of 2 to10 days]
- Operative time (procedure start to procedure finish measured in minutes) [Day of surgery]
- Quality of Life via questionnaire [Baseline and Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years]
- Cost for hospital charges from billing office [Through study completion, an average of 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ventral or incisional hernia measuring ≥ 7 cm and ≤ 15 cm.
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At least one of the following risk factors: Body Mass Index > 30, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, current smoker (within 1 month)
Exclusion Criteria:
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Current abdominal wall infection
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Presence of ileostomy, colostomy, or ileal conduit
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Center for Disease Control wound class 3 or 4
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Hernia defect < 7 cm or >15 cm
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Pregnant women
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Prisma Health-Upstate
Investigators
- Principal Investigator: Jeremy A Warren, MD, Prisma Health-Upstate
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00062464