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PI on an extended leave of absence.
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Randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia repair.
Inguinal hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic | Active Comparator | laparoscopic inguinal hernia repair |
|
| robot-assisted | Active Comparator | robot-assisted inguinal hernia repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic repair | Procedure | Surgical inguinal hernia repair using laparoscopic approach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Time from start to finish of procedure, procedure start and stop times as recorded by anesthesia. | Immediate perioperative time |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score | Abdominal pain at rest and on moving (recumbent to the upright position), will be assessed using 0-10 Numeric Pain Rating Scale preoperatively (baseline), and at 24 hours, 30 days, one and five years postoperatively. | Until 5 year postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Postoperative 30 day complication rates will be recorded prospectively. All complications (including multiple occurrences per patient) will be recorded and graded per the Clavien-Dindo classification system. | From immediately post-operative until year five following surgical inguinal hernia repair. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Latzko, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
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| 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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Participants will be randomized to receive either laparoscopic or robot-assisted repair of inguinal hernia.
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| robot-assisted repair | Procedure | Surgical inguinal hernia repair using robot-assisted approach. |
|