Pain and Quality of Life After Inguinal Hernia Repair

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Laparoscopic Inguinal Hernia Repair; Procedure: Open Inguinal Hernia Repair; Device: Robotic-Assisted Inguinal Hernia Repair

• Registration Number: NCT04074200
• Lead Sponsor: Intuitive Surgical

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.

Study Timeline

• Study First Submitted: 2019-08-22
• Study Start: 2019-08-26
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-29
• Primary Completion: 2023-07-06
• Study Completion: 2023-07-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Subject is between 18 and 80 years of age.
• Subject is a candidate for an elective primary inguinal hernia repair.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic Inguinal Hernia Repair	Laparoscopic Inguinal Hernia Repair	These subjects will undergo an inguinal hernia repair using a laparoscopic surgical approach.
Open Inguinal Hernia Repair	Open Inguinal Hernia Repair	These subjects will undergo an inguinal hernia repair using an open surgical approach.
Robotic-assisted Inguinal Hernia Repair	Robotic-Assisted Inguinal Hernia Repair	These subjects will undergo an inguinal hernia repair using a robotic-assisted surgical approach.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Complications	Intra-operative through the 3 month follow-up period	Intra-operative or post-operative complications related to the inguinal hernia repair
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
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
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
Conversion to Open	Intra-operative	Incidence of conversions of the laparoscopic or robotic-assisted procedure

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States