Clinical trial NCT04074200: Pain and Quality of Life After Inguinal Hernia Repair
Official title: PREPARE: A PRospective Evaluation of Pain After Inguinal Hernia REpair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will undergo an elective hernia repair procedure and meet all eligibility criteria will be considered for enrollment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain Scores from Baseline to 14 Days
timeFrame: 14 days post-surgery
measure: Change in Pain Scores from Baseline to 1 Day
timeFrame: 1 day post-surgery
measure: Change in Pain Scores from Baseline to 2 Days
timeFrame: 2 days post-surgery
measure: Change in Pain Scores from Baseline to 3 Days
timeFrame: 3 days post-surgery
measure: Change in Narcotic Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
timeFrame: 3 months post-surgery
measure: Change in Narcotic Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
timeFrame: 30 days post-surgery
measure: Change in Narcotic Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
timeFrame: 14 days post-surgery
measure: Change in Narcotic Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
timeFrame: 7 days post-surgery
Secondary outcomes:
measure: Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
timeFrame: 7 days post-surgery
measure: Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
timeFrame: 3 months post-surgery
measure: Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
timeFrame: 30 Days post-surgery
measure: Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
timeFrame: 14 Days post-surgery
measure: Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 3 Months Post-Surgery
timeFrame: 3 months post-surgery
measure: Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 30 Days Post-Surgery
timeFrame: 30 Days post-surgery
measure: Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 14 Days Post-Surgery
timeFrame: 14 Days post-surgery
measure: Operative Time
timeFrame: Intra-operative
measure: Length of Hospital Stay (LOS)
timeFrame: Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week
measure: Conversion to Open
timeFrame: Intra-operative
measure: Number of Complications
timeFrame: Intra-operative through the 3 month follow-up period
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: