Open Versus Robotic Retromuscular Ventral Hernia Repair (ORREO)
Primary Purpose
Ventral Hernia
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
open ventral hernia repair
robotic ventral hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernia focused on measuring Hernia repair, Robotic hernia repair, Open hernia repair, Incisional hernia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
robotic ventral hernia repair (VHR)
open ventral hernia repair (VHR)
Arm Description
Robotic VHR
Open VHR
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
All surgical site occurrences
Surgical site occurrences requiring procedural intervention
All surgical site infections
Surgical site infections requiring procedural intervention
Length of stay at hospital measured in days
Operative time (procedure start to procedure finish measured in minutes)
Quality of Life via questionnaire
Cost for hospital charges from billing office
Full Information
NCT ID
NCT03007758
First Posted
December 15, 2016
Last Updated
January 17, 2023
Sponsor
Prisma Health-Upstate
1. Study Identification
Unique Protocol Identification Number
NCT03007758
Brief Title
Open Versus Robotic Retromuscular Ventral Hernia Repair
Acronym
ORREO
Official Title
Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
Hernia repair, Robotic hernia repair, Open hernia repair, Incisional hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
robotic ventral hernia repair (VHR)
Arm Type
Active Comparator
Arm Description
Robotic VHR
Arm Title
open ventral hernia repair (VHR)
Arm Type
Active Comparator
Arm Description
Open VHR
Intervention Type
Procedure
Intervention Name(s)
open ventral hernia repair
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
robotic ventral hernia repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence
Description
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.
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
All surgical site occurrences
Time Frame
Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Title
Surgical site occurrences requiring procedural intervention
Time Frame
Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Title
All surgical site infections
Time Frame
Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Title
Surgical site infections requiring procedural intervention
Time Frame
Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Title
Length of stay at hospital measured in days
Time Frame
Time from procedure until discharge, an expected range of 2 to10 days
Title
Operative time (procedure start to procedure finish measured in minutes)
Time Frame
Day of surgery
Title
Quality of Life via questionnaire
Time Frame
Baseline and Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Title
Cost for hospital charges from billing office
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy A Warren, MD
Organizational Affiliation
Prisma Health-Upstate
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All patients will be entered prospectively into the Americas Hernia Society Quality Collaborative (AHSQC) database.
Learn more about this trial
Open Versus Robotic Retromuscular Ventral Hernia Repair
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