Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair

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