Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-31 @ 8:41 PM
Study NCT ID:
NCT03007758
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2016-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open Versus Robotic Retromuscular Ventral Hernia Repair
Sponsor:
Prisma Health-Upstate
Organization:
Study Overview
Official Title:
Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORREO
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: