Open Versus Robotic Retromuscular Ventral Hernia Repair

Not Applicable

Completed

• Conditions: Ventral Hernia
• Interventions: Procedure: robotic ventral hernia repair; Procedure: open ventral hernia repair

• Registration Number: NCT03007758
• Lead Sponsor: Prisma Health-Upstate

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2017-01-02
• Status Verified: 2024-02
• Primary Completion: 2024-11-26
• Study Completion: 2024-11-26
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
robotic ventral hernia repair (VHR)	robotic ventral hernia repair	Robotic VHR
open ventral hernia repair (VHR)	open ventral hernia repair	Open VHR

Primary Outcome Measures

Name	Time	Method
Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence	Through study completion, an average of 2 years	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.

Secondary Outcome Measures

Name	Time	Method
All surgical site infections	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
Quality of Life via questionnaire	Baseline and 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 occurrences	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
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