This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.
This is a prospective, multi-center, observational pilot study comparing outcomes of pain and quality of life after inguinal hernia repair between open, laparoscopic, and robotic-assisted surgical approaches. The study will focus on short-term outcomes through 3 months post-operation. During the post-operative period through 3 months, pain medication intake, pill count, subject-reported pain (on post-operative days 1-3 and 14 days post-surgery), and quality of life (at 14 days, 30 days, and 3 months post-surgery), incidence of intra- and post-operative complications, and time to return to normal activity will be collected.
Study Type
OBSERVATIONAL
Enrollment
156
With the patient under anesthesia, a single incision is made in the groin area. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific open approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
With the patient under general anesthesia, several small incisions are made in the groin area. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope (a lighted scope used to visualize the hernia) are inserted to complete the repair. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific laparoscopic approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Change in Pain Scores from Baseline to 14 Days
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: 14 days post-surgery
Change in Pain Scores from Baseline to 1 Day
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: 1 day post-surgery
Change in Pain Scores from Baseline to 2 Days
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: 2 days post-surgery
Change in Pain Scores from Baseline to 3 Days
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: 3 days post-surgery
Change in Narcotic Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Time frame: 3 months post-surgery
Change in Narcotic Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
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With the patient under general anesthesia, several small incisions are made in the groin area. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the procedure. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific robotic-assisted approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
Time frame: 30 days post-surgery
Change in Narcotic Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Time frame: 14 days post-surgery
Change in Narcotic Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
Narcotic usage after the inguinal hernia repair procedure as determined by patient Pain Diary completed at home
Time frame: 7 days post-surgery
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
Over the counter (OTC) pain medication usage after the inguinal hernia repair procedure as determined by patient Pain Diary completed at home
Time frame: 7 days post-surgery
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
Over the counter (OTC) pain medication usage after the inguinal hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-up visits
Time frame: 3 months post-surgery
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
Over the counter (OTC) pain medication usage after the inguinal hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-up visits
Time frame: 30 Days post-surgery
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
Over the counter (OTC) pain medication usage after the inguinal hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-up visits
Time frame: 14 Days post-surgery
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 3 Months Post-Surgery
Quality of life assessment using the EQ-5D-5L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Time frame: 3 months post-surgery
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 30 Days Post-Surgery
Quality of life assessment using the EQ-5D-5L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Time frame: 30 Days post-surgery
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 14 Days Post-Surgery
Quality of life assessment using the EQ-5D-5L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Time frame: 14 Days post-surgery
Operative Time
Operative time, defined as first incision to closure of the incision
Time frame: Intra-operative
Length of Hospital Stay (LOS)
How long the patient was admitted to the hospital
Time frame: Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week
Conversion to Open
Incidence of conversions of the laparoscopic or robotic-assisted procedure
Time frame: Intra-operative
Number of Complications
Intra-operative or post-operative complications related to the inguinal hernia repair
Time frame: Intra-operative through the 3 month follow-up period