Open Versus Robotic Retromuscular Ventral Hernia Repair

Study Overview
=================
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.

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.

Official Title
-----------------
Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Procedure: open ventral hernia repair
* Procedure: robotic ventral hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ventral or incisional hernia measuring ≥ 7 cm and ≤ 15 cm. 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: Current abdominal wall infection Presence of ileostomy, colostomy, or ileal conduit Center for Disease Control wound class 3 or 4 Hernia defect < 7 cm or >15 cm Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: robotic ventral hernia repair (VHR)<br>Robotic VHR | Procedure: robotic ventral hernia repair<br>* 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.<br>|
| Active Comparator: open ventral hernia repair (VHR)<br>Open VHR | Procedure: open ventral hernia repair<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence | 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. | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hernia repair, Robotic hernia repair, Open hernia repair, Incisional hernia