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: Active, not recruiting
• 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 (Estimated): 100
• 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	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

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 (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

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): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

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.