A prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the Medtronic Hugo™ RAS system. Subjects will be followed through two years. This study will be conducted using up to ten investigative sites in the United States (US).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
193
Patients indicated for Robotic-Assisted Surgery (RAS) for ventral and inguinal hernia repair will have the RAS surgery using the Medtronic Hugo RAS system
Tampa General Hospital
Tampa, Florida, United States
University of Illinois, Chicago
Chicago, Illinois, United States
University of Buffalo
Buffalo, New York, United States
Duke University
Durham, North Carolina, United States
Surgical success rate
Rate of conversions from Hugo™ System to laparoscopic, open surgery, or use of an alternative robotic-assisted system.
Time frame: 2 Years
Surgical site event rate
The primary safety endpoint is the overall rate of subjects with one or more procedure- and/or device-related surgical site events (SSEs), from the first incision through 30 days post-procedure. SSE is defined as the following complications: * Surgical-site occurrence (SSO): Bleeding, Hemorrhage: Requiring transfusion; Bowel Injury; Bowel Obstruction; Cellulitis; Epigastric Vessel Injury; Symptomatic Hematoma: Requiring procedural intervention; Symptomatic Seroma: Requiring procedural intervention; Symptomatic Edema: Requiring procedural intervention * Surgical-site infection (SSI): Infection occurring where the surgery took place, including superficial, deep, and organ space infections (standardized definition developed by the CDC)
Time frame: 2 Years
Complication rate
Overall rate of patients with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure.
Time frame: 30 Days
Operative time
Time from skin incision to skin closure.
Time frame: Intraoperative
Major Complication Rate
Overall rate of subjects with one or more major procedure- and/or device-related complications (Clavien-Dindo Grade III or higher), from the first incision through 30 days post-procedure.
Time frame: 30 Days
Readmission rate through 30 days post-procedure
Admission for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia.
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Cleveland Clinic
Cleveland, Ohio, United States
UT Health
Houston, Texas, United States
Bon Secours
Newport News, Virginia, United States
Time frame: 30 Days
Reoperation rate through 30 days post-procedure
Operation for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia.
Time frame: 30 Days
Recurrence rate through 2 years post-procedure
Clinical hernia recurrence is defined as a palpable fascial defect and/or a clinically manifested bulge within 7 cm of the original repair, exacerbated by a Valsalva maneuver during physical examination by a study investigator. Suspected hernia recurrence(s) reported by a subject, but not confirmed by an investigator, will not be considered as a clinical hernia recurrence for this endpoint, but will be reported separately as a subject-reported recurrence.
Time frame: 2 Years
Recurrence rate through 30 days post-procedure
Clinical hernia recurrence is defined as a palpable fascial defect and/or a clinically manifested bulge within 7 cm of the original repair, exacerbated by a Valsalva maneuver during physical examination by a study investigator.
Time frame: 30 Days