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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:
The total duration for this study will be approximately 12 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-Assisted Inguinal Hernia Repair | Subjects who have undergone robotic-assisted (da Vinci) inguinal hernia repair from the initiation of robotic-assisted hernia repair at site through December 2015. |
| |
| Open Inguinal Hernia Repair | Subjects who have undergone open inguinal hernia repair from the day prior to initiation of robotic-assisted hernia repair through 5 years prior to initiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inguinal Hernia Repair | Procedure | Inguinal (unilateral or bilateral) hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of complications observed intraoperatively through 30-days | Intraoperative through 30-days follow-up |
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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:
Exclusion Criteria:
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All subjects who have undergone robotic-assisted inguinal hernia repair or open hernia repair per specified time frame described in inclusion/exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Progressive Surgical Associates/Silver Cross Hospital | New Lenox | Illinois | 60451 | United States | ||
| Rochester General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29713930 | Derived | Dickens EO, Kolachalam R, Gonzalez A, Richardson C, D'Amico L, Rabaza J, Gamagami R. Does robotic-assisted transabdominal preperitoneal (R-TAPP) hernia repair facilitate contralateral investigation and repair without compromising patient morbidity? J Robot Surg. 2018 Dec;12(4):713-718. doi: 10.1007/s11701-018-0815-4. Epub 2018 Apr 30. |
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Individual participant data will not be shared.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 11, 2021 | |
| Reset | Jun 3, 2021 | |
| Release | Aug 10, 2021 | |
| Reset | Sep 3, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2021 | Jun 3, 2021 | |||
| Aug 10, 2021 |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059685 | Herniorrhaphy |
| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Rochester |
| New York |
| 14621 |
| United States |
| Sep 3, 2021 |