Open Versus Robotic Retromuscular Ventral Hernia Repair (ORREO)

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: robotic ventral hernia repair; Procedure: open ventral hernia repair

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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	Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections.	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	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.	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
Cost for Hospital Charges From Billing Office		Through study completion, an average of 2 years
BMI	Body Mass Index	Measured at study enrollment
Hernia Width	Width of Hernia	measured at surgery
Hernia Length	Length of Hernia	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.	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.	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.	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.	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.	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.	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.	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.	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.	assessed Post-operatively as 24 months
Conversion to Open	Robotic surgeries converted to open surgeries.	Assessed at index surgery.

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Investigators: Principal Investigator: Jeremy A Warren, MD, Prisma Health-Upstate

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): November 26, 2024
• Study Completion (Actual): November 26, 2024

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimated): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Incisional hernia; Hernia repair; Robotic hernia repair; Open hernia repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: Pro00062464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All patients will be entered prospectively into the Americas Hernia Society Quality Collaborative (AHSQC) database.

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No