Open Versus Robotic Retromuscular Ventral Hernia Repair

NCT ID: NCT03007758

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2024-11-26

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.

Conditions

Ventral Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

robotic ventral hernia repair (VHR)

Robotic VHR

Group Type: ACTIVE_COMPARATOR

robotic ventral hernia repair

Intervention Type: PROCEDURE

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.

open ventral hernia repair (VHR)

Open VHR

Group Type: ACTIVE_COMPARATOR

open ventral hernia repair

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy A Warren, MD

Role: PRINCIPAL_INVESTIGATOR

Prisma Health-Upstate

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00062464

Identifier Type: -

Identifier Source: org_study_id