Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair
Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair
This multi-center, retrospective data collection study will evaluate the feasibility, safety
 and performance of the da Vinci® surgical system for patients who have undergone
 robotic-assisted inguinal hernia repair, as well as provide information about the learning
 curve associated with robotic-assisted (da Vinci®) inguinal hernia repair.

 In addition, this retrospective data collection study will evaluate the perioperative
 outcomes of robotic-assisted (da Vinci®) inguinal hernia repair and compare perioperative
 outcomes with those associated with open hernia repair by the same participating surgeon.
This study is a retrospective data collection from existing medical records, is observational
 in nature and is designed to evaluate feasibility, safety and performance of the da Vinci®
 surgical system for patients who have undergone inguinal hernia repair surgery during the
 time period from initiation of robotic-assisted surgery to 30 days prior to study initiation
 (IRB approval and fully executed data collection agreement) for approximately 500 subjects.
 Any inguinal hernia repair procedure that uses the da Vinci® surgical system at any point
 will be collected.

 This data will be compared with data associated with open inguinal hernia repairs performed
 by the same surgeons from a period of 5 years prior to the initiation of robotic surgery at
 each participating institution until 30 days prior to study initiation. Sites will collect
 data from consecutive open inguinal hernia repair cases starting with the day prior to the
 1st robotic-assisted inguinal hernia repair, and continue collecting data until the number of
 open inguinal hernia repair cases is equivalent to the number of robotic-assisted inguinal
 hernia repair cases, or until the open repair procedure date reaches 5 years prior to the 1st
 robotic-assisted inguinal hernia repair case.

 Data collected will include, but is not limited to, the following:

 1. Demographics and baseline/pre-operative clinical parameters: Gender, age, BMI,
 comorbidities, smoking history, prior hernia history, prior abdominal surgery history,
 hernia description

 2. Intraoperative parameters: procedure details related to repair, operative time,
 conversions to open, blood loss, intraoperative complications

 3. Post-operative through discharge : length of hospital stay, post-operative complications

 4. Post-operative information regarding complications, readmissions and reoperations
 through 30 days post-discharge.

 5. Hernia Recurrence, if available

 The total duration for this study will be approximately 12 months
Inclusion Criteria:

 all patients who have undergone inguinal hernia repair using either an open technique or a
 robotic-assisted (da Vinci®) approach

 Eligible subjects must have had their inguinal hernia repair completed according to the
 following timeframes for inclusion:

 1. Robotic-assisted (da Vinci®) hernia repair - all consecutive robotic cases from the
 initiation of robotic -assisted inguinal hernia repair at each institution until 30
 days prior to the date of study initiation (IRB approval and fully executed contract).

 2. Open hernia repair - all consecutive open hernia repair cases from the day prior to
 the 1st da Vinci® inguinal hernia repair until the number of open repair cases
 collected is equivalent to the number of da Vinci® cases entered, or the date 5 years
 pre-robotic initiation is reached.

 Exclusion Criteria:

 -  Subjects who have undergone robotic-assisted or open inguinal hernia repair outside of
 required timeframe