Open Versus Robotic Retromuscular Ventral Hernia Repair

NCT03007758 | Completed Results

• 1 other identifier: Pro00062464
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ventral Hernia

Keywords

Hernia repair; Robotic hernia repair; Open hernia repair; Incisional hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• 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

Study Arms (2)

robotic ventral hernia repair (VHR)

ACTIVE COMPARATOR

Robotic VHR

Procedure: robotic ventral hernia repair

open ventral hernia repair (VHR)

ACTIVE COMPARATOR

Open VHR

Procedure: open ventral hernia repair

Interventions

open ventral hernia repair 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.

open ventral hernia repair (VHR)

robotic ventral hernia repair 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.

robotic ventral hernia repair (VHR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Abby Birrell, Study Coordinator
• Organization: Prisma Health

abby.birrell@prismahealth.org

8645222117

Study Officials

• Jeremy A Warren, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: January 2, 2017
• Study Start: December 1, 2016
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share