N/A
N=101
Open Versus Robotic Retromuscular Ventral Hernia Repair
Ventral Hernia
Bottom Line
View on ClinicalTrials.gov: NCT03007758 ↗Enrolled (actual)
101
Serious AEs
14.9%
Results posted
Aug 2025
Primary outcome: Primary: Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence — 9; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- open ventral hernia repair (Procedure); robotic ventral hernia repair (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Prisma Health-Upstate
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence |
9; 9 | — |
| SECONDARY All Surgical Site Occurrences |
8; 7 | — |
| SECONDARY Surgical Site Occurrences Requiring Procedural Intervention |
6; 3 | — |
| SECONDARY All Surgical Site Infections |
2; 3 | — |
| SECONDARY Surgical Site Infections Requiring Procedural Intervention |
6; 3 | — |
| SECONDARY Length of Stay at Hospital Measured in Days |
1; 2 | — |
| SECONDARY Operative Time (Procedure Start to Procedure Finish Measured in Minutes) |
206; 156 | — |
| SECONDARY Cost for Hospital Charges From Billing Office |
11747; 9267 | — |
| SECONDARY BMI |
36.7; 36.7 | — |
| SECONDARY Hernia Width |
8; 10 | — |
| SECONDARY Hernia Length |
15; 15 | — |
| SECONDARY Quality of Life Via Questionnaire - 30 Days |
34; 28; 38; 50; 0; 16 | — |
| SECONDARY Quality of Life Via Questionnaire - 6 Through 12 Months |
26; 46; 86; 90; 60; 20 | — |
| SECONDARY Quality of Life Via Questionnaire - 24 Months |
36; 32; 80; 91; 28; 59 | — |
| SECONDARY Pain Score - 30 Day Patient Reported Outcomes |
2; 3; 3; 2; 1; 0 | — |
| SECONDARY Pain Score - 6 or 12 Month Patient Reported Outcomes |
2; 2; 1; 1; -1; -1 | — |
| SECONDARY Pain Score - 24 Month Patient Reported Outcomes |
2; 2; 1; 1; -1; -1 | — |
| SECONDARY Ventral Hernia Recurrence Inventory 1 Year |
9; 5; 16; 7; 2; 2 | — |
| SECONDARY Ventral Hernia Recurrence Inventory 2 Years |
8; 4; 11; 3; 7; 1 | — |
| SECONDARY Hernia Recurrence |
11; 4; 4; 1 | — |
| SECONDARY Conversion to Open |
5; 0 | — |
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.
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 15 cm
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT03007758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.