Ventral HerniaORREONCT03007758
Open Versus Robotic Retromuscular Ventral Hernia Repair
A study testing open ventral hernia repair and robotic ventral hernia repair in people with Ventral Hernia, run by Prisma Health-Upstate.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- open ventral hernia repair and robotic ventral hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 26 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)
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.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- open ventral hernia repair, robotic ventral hernia repair
- Keywords
- Hernia repair, Robotic hernia repair, Open hernia repair, Incisional hernia
- Medical subject headings
- Hernia, Ventral, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open ventral hernia repairProcedure or surgery
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.
robotic ventral hernia repairProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| robotic ventral hernia repair (VHR) | Active comparator | Robotic VHR Receives: Procedure: robotic ventral hernia repair |
| open ventral hernia repair (VHR) | Active comparator | Open VHR Receives: Procedure: open ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 years
Secondary outcomes (20)
All Surgical Site Occurrences
Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections.
Measured: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Surgical Site Occurrences Requiring Procedural Intervention
Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections
Measured: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
All Surgical Site Infections
Surgical site occurrence is defined as all wound complications that occur after a surgical procedure but are not surgical site infections.
Measured: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Surgical Site Infections Requiring Procedural Intervention
Measured: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Length of Stay at Hospital Measured in Days
Measured: Time from procedure until discharge, an expected range of 2 to10 days
Operative Time (Procedure Start to Procedure Finish Measured in Minutes)
Measured: Day of surgery
Cost for Hospital Charges From Billing Office
Measured: Through study completion, an average of 2 years
BMI
Body Mass Index
Measured: Measured at study enrollment
Hernia Width
Width of Hernia
Measured: measured at surgery
Hernia Length
Length of Hernia
Measured: measured at surgery
Quality of Life Via Questionnaire - 30 Days
Patient reported outcomes via the Hernia related quality of life score. The survey contains 12 statements about the patients abdominal wall and asks the patient to rate how strongly the disagree (1) or agree (6) with the statements on a scale 1-6. The score is calculated with the following formula: (120-[(20/12)*(sum of response on all 12 questions)]).The highest possible number, meaning the abdominal wall does not affect the patient, is 100, and the lowest, meaning the abdominal wall greatly affects the patient's quality of life, is a 0.
Measured: assessed at Baseline and Post-operatively at 30 days
Quality of Life Via Questionnaire - 6 Through 12 Months
Patient reported outcomes via the Hernia related quality of life score. The survey contains 12 statements about the patients abdominal wall and asks the patient to rate how strongly the disagree (1) or agree (6) with the statements on a scale 1-6.The score is calculated with the following formula: (120-[(20/12)*(sum of response on all 12 questions)]).The highest possible number, meaning the abdominal wall does not affect the patient, is 100, and the lowest, meaning the abdominal wall greatly affects the patient's quality of life, is a 0.
Measured: assessed at Baseline and Post-operatively at 6 through 12 months. Data for the 6 and 12-month patient reported outcomes were combined for analysis.
Quality of Life Via Questionnaire - 24 Months
Patient reported outcomes via the Hernia related quality of life score. The survey contains 12 statements about the patients abdominal wall and asks the patient to rate how strongly the disagree (1) or agree (6) with the statements on a scale 1-6. The score is calculated with the following formula: (120-[(20/12)*(sum of responses on all 12 questions)]).The highest possible number, meaning the abdominal wall does not affect the patient, is 100, and the lowest, meaning the abdominal wall greatly affects the patient's quality of life, is a 0.
Measured: assessed at Baseline and Post-operatively at 24 months
Pain Score - 30 Day Patient Reported Outcomes
Patient is asked 3 different questions all in relation to their pain in the past 7 days: how intense was it as its worst, on average, and right now. They then rank their pain for each question on a scale of 1 - 5. 1 meaning no pain and 5 very severe pain. The pain scores were then averaged and used for this analysis.
Measured: assessed at Baseline and Post-operatively at 30 days.
Pain Score - 6 or 12 Month Patient Reported Outcomes
Patient is asked 3 different questions all in relation to their pain in the past 7 days: how intense was it as its worst, on average, and right now. They then rank their pain for each question on a scale of 1 - 5. 1 meaning no pain and 5 very severe pain. The pain scores were then averaged and used for this analysis.
Measured: assessed at Baseline and Post-operatively at 6-12 months; data for 6 and 12-month pain scores were combined for analysis.
Pain Score - 24 Month Patient Reported Outcomes
Patient is asked 3 different questions all in relation to their pain in the past 7 days: how intense was it as its worst, on average, and right now. They then rank their pain for each question on a scale of 1 - 5. 1 meaning no pain and 5 very severe pain. The pain scores were then averaged and used for this analysis.
Measured: assessed at Baseline and Post-operatively at 24 months
Ventral Hernia Recurrence Inventory 1 Year
Patients are asked 3 yes or no questions about their hernia operation: do you feel your hernia has come back, do you feel or see a bulge, and do you have physical pain or symptoms at the site.
Measured: assessed at Baseline and Post-operatively at 12 months.
Ventral Hernia Recurrence Inventory 2 Years
Patients are asked 3 yes or no questions about their hernia operation: do you feel your hernia has come back, do you feel or see a bulge, and do you have physical pain or symptoms at the site.
Measured: assessed at Baseline and Post-operatively at 24 months
Hernia Recurrence
The ventral hernia recurrence inventory asked patients if they have had any additional surgery since the hernia operation. If they answer yes, they choose if the surgery was for a hernia or another reason. The answers from 1 year follow up and 2 year follow up to the last question were combined for this analysis. Composite recurrence was then determined by excluding patients with negative CT scan or physical exam but had answered the ventral hernia recurrence inventory indication the hernia recurrence.
Measured: assessed Post-operatively as 24 months
Conversion to Open
Robotic surgeries converted to open surgeries.
Measured: Assessed at index surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy A Warren, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007758
- Sponsor's protocol ID
- Pro00062464
- Acronym
- ORREO
- Status last verified
- Aug 2025
- First submitted
- 15 Dec 2016
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: All patients will be entered prospectively into the Americas Hernia Society Quality Collaborative (AHSQC) database.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)
- ClinicalTrials.gov ID
- NCT03007758
- Acronym / sponsor ID
- ORREO / Pro00062464
- Conditions
- Ventral Hernia
- Keywords
- Hernia repair, Robotic hernia repair, Open hernia repair, Incisional hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic ventral hernia repair (VHR) | Active comparator | Procedure: robotic ventral hernia repairRobotic VHR |
| open ventral hernia repair (VHR) | Active comparator | Procedure: open ventral hernia repairOpen VHR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open ventral hernia repairAn 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. | Procedure or surgery | open ventral hernia repair (VHR) |
| robotic ventral hernia repairA 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. | Procedure or surgery | robotic ventral hernia repair (VHR) |
Primary outcome
Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence
Time frame: 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.
20 secondary outcomes
All Surgical Site Occurrences
Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Surgical Site Occurrences Requiring Procedural Intervention
Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
All Surgical Site Infections
Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Surgical Site Infections Requiring Procedural Intervention
Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
Length of Stay at Hospital Measured in Days
Time frame: Time from procedure until discharge, an expected range of 2 to10 days
Operative Time (Procedure Start to Procedure Finish Measured in Minutes)
Time frame: Day of surgery
Cost for Hospital Charges From Billing Office
Time frame: Through study completion, an average of 2 years
BMI
Time frame: Measured at study enrollment
Hernia Width
Time frame: measured at surgery
Hernia Length
Time frame: measured at surgery
Quality of Life Via Questionnaire - 30 Days
Time frame: assessed at Baseline and Post-operatively at 30 days
Quality of Life Via Questionnaire - 6 Through 12 Months
Time frame: assessed at Baseline and Post-operatively at 6 through 12 months. Data for the 6 and 12-month patient reported outcomes were combined for analysis.
Quality of Life Via Questionnaire - 24 Months
Time frame: assessed at Baseline and Post-operatively at 24 months
Pain Score - 30 Day Patient Reported Outcomes
Time frame: assessed at Baseline and Post-operatively at 30 days.
Pain Score - 6 or 12 Month Patient Reported Outcomes
Time frame: assessed at Baseline and Post-operatively at 6-12 months; data for 6 and 12-month pain scores were combined for analysis.
Pain Score - 24 Month Patient Reported Outcomes
Time frame: assessed at Baseline and Post-operatively at 24 months
Ventral Hernia Recurrence Inventory 1 Year
Time frame: assessed at Baseline and Post-operatively at 12 months.
Ventral Hernia Recurrence Inventory 2 Years
Time frame: assessed at Baseline and Post-operatively at 24 months
Hernia Recurrence
Time frame: assessed Post-operatively as 24 months
Conversion to Open
Time frame: Assessed at index surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All patients will be entered prospectively into the Americas Hernia Society Quality Collaborative (AHSQC) database.
Related trials for Ventral Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Active, not recruitingObservational study
ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery
Ventral Hernia Repair
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy A Warren, MD principal investigator
Prisma Health-Upstate
Questions about this trial
What is this clinical trial studying?
A study testing open ventral hernia repair and robotic ventral hernia repair in people with Ventral Hernia, run by Prisma Health-Upstate.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.