Inguinal Hernia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREOpen Inguinal Hernia Repair
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.
PROCEDURELaparoscopic Inguinal Hernia Repair
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.
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.
Sponsors
Intuitive Surgical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject is between 18 and 80 years of age. * Subject is a candidate for an elective primary inguinal hernia repair.
Exclusion criteria
* Subject receiving a bilateral open repair. * Subject who will have an emergent hernia repair. * Subject with a history of chronic pain and/or taking daily pain medications for \>6 weeks. * Subject with a history of substance abuse and/or current (within 30 days) narcotic use. * Subject with a history of methicillin-resistant Staphylococcus aureus (MRSA) infection. * Diabetic subjects requiring insulin. * Subject with recurrent hernias. * Subject who will require the use of Exparel during the surgical procedure. * Subject who will undergo a concomitant hernia repair or any other concomitant procedure. * Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery. * Subject is contraindicated for surgery. * Subject has a known bleeding or clotting disorder. * Pregnant or suspect pregnancy. * Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent. * Subject belonging to other vulnerable population, e.g, prisoner or ward of the state. * Subject unable to comply with the follow-up visit schedule. * Subject is currently participating in another research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Scores from Baseline to 14 Days | 14 days post-surgery | 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). |
| Change in Pain Scores from Baseline to 1 Day | 1 day post-surgery | 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). |
| Change in Pain Scores from Baseline to 2 Days | 2 days post-surgery | 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). |
| Change in Pain Scores from Baseline to 3 Days | 3 days post-surgery | 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). |
| Change in Narcotic Usage from 1 Day Post-Surgery to 3 Months Post-Surgery | 3 months post-surgery | Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits |
| Change in Narcotic Usage from 1 Day Post-Surgery to 30 Days Post-Surgery | 30 days post-surgery | Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits |
| Change in Narcotic Usage from 1 Day Post-Surgery to 14 Days Post-Surgery | 14 days post-surgery | Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits |
| Change in Narcotic Usage from 1 Day Post-Surgery to 7 Days Post-Surgery | 7 days post-surgery | Narcotic usage after the inguinal hernia repair procedure as determined by patient Pain Diary completed at home |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay (LOS) | Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week | How long the patient was admitted to the hospital |
| Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 7 Days Post-Surgery | 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 |
| Number of Complications | Intra-operative through the 3 month follow-up period | Intra-operative or post-operative complications related to the inguinal hernia repair |
| Conversion to Open | Intra-operative | Incidence of conversions of the laparoscopic or robotic-assisted procedure |
| Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 3 Months Post-Surgery | 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 |
| Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 30 Days Post-Surgery | 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 |
| Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 14 Days Post-Surgery | 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 |
| Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 3 Months Post-Surgery | 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). |
| Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 30 Days Post-Surgery | 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). |
| Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 14 Days Post-Surgery | 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). |
| Operative Time | Intra-operative | Operative time, defined as first incision to closure of the incision |
Countries
United States
Outcome results
None listed