Clinical Trial: Open Versus Robotic Retromuscular Ventral Hernia Repair

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)

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 Summary: 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.
Sponsor: Greenville Health System

Current Primary Outcome: Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • All surgical site occurrences [ Time Frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years ]
  • Surgical site occurrences requiring procedural intervention [ Time Frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years ]
  • All surgical site infections [ Time Frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years ]
  • Surgical site infections requiring procedural intervention [ Time Frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years ]
  • Length of stay at hospital measured in days [ Time Frame: Time from procedure until discharge, an expected range of 2 to10 days ]
  • Operative time (procedure start to procedure finish measured in minutes) [ Time Frame: Day of surgery ]
  • Quality of Life via questionnaire [ Time Frame: Baseline and Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years ]
  • Cost for hospital charges from billing office [ Time Frame: Through study completion, an average of 2 years ]


Original Secondary Outcome: Same as current

Information By: Greenville Health System

Dates:
Date Received: December 15, 2016
Date Started: December 2016
Date Completion: December 2019
Last Updated: December 28, 2016
Last Verified: December 2016