Open Versus Robotic Retromuscular Ventral Hernia Repair (ORREO)

Prisma Health-Upstate

Status: Completed

Conditions: Ventral Hernia

Treatments: Procedure: open ventral hernia repair; Procedure: robotic ventral hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT03007758

Pro00062464

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

robotic ventral hernia repair (VHR)

Active Comparator group

Description:

Robotic VHR

Treatment:

Procedure: robotic ventral hernia repair

open ventral hernia repair (VHR)

Active Comparator group

Description:

Open VHR

Treatment:

Procedure: open ventral hernia repair