Pain and Quality of Life After Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

— PREPARE  

Official title:

PREPARE: A PRospective Evaluation of Pain After Inguinal Hernia REpair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04074200
• Other study ID #: ISI-IHP-2018
• Status: Recruiting
• Start date: August 26, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Intuitive Surgical
• Contact: Alison Gorski
• Phone: 4085231855
• Email: alison.gorski[@]intusurg.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Open 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.
• Laparoscopic 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.

Device:
• Robotic-Assisted 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 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	14 days post-surgery
Primary	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).	1 day post-surgery
Primary	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).	2 days post-surgery
Primary	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).	3 days post-surgery
Primary	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	3 months post-surgery
Primary	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	30 days post-surgery
Primary	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	14 days post-surgery
Primary	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	7 days post-surgery
Secondary	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	7 days post-surgery
Secondary	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	3 months post-surgery
Secondary	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	30 Days post-surgery
Secondary	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	14 Days post-surgery
Secondary	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).	3 months post-surgery
Secondary	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).	30 Days post-surgery
Secondary	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).	14 Days post-surgery
Secondary	Operative Time	Operative time, defined as first incision to closure of the incision	Intra-operative
Secondary	Length of Hospital Stay (LOS)	How long the patient was admitted to the hospital	Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week
Secondary	Conversion to Open	Incidence of conversions of the laparoscopic or robotic-assisted procedure	Intra-operative
Secondary	Number of Complications	Intra-operative or post-operative complications related to the inguinal hernia repair	Intra-operative through the 3 month follow-up period