Pain and Quality of Life After Inguinal Hernia Repair (PREPARE)

October 1, 2024 updated by: Intuitive Surgical

PREPARE: A PRospective Evaluation of Pain After Inguinal Hernia REpair

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Open Inguinal Hernia Repair
These subjects will undergo an inguinal hernia repair using an open surgical approach.
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
These subjects will undergo an inguinal hernia repair using a laparoscopic surgical approach.
Procedure: 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.
Robotic-assisted Inguinal Hernia Repair
These subjects will undergo an inguinal hernia repair using a robotic-assisted surgical approach.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pain Scores from Baseline to 14 Days
Time Frame: 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).
14 days post-surgery
Change in Pain Scores from Baseline to 1 Day
Time Frame: 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).
1 day post-surgery
Change in Pain Scores from Baseline to 2 Days
Time Frame: 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).
2 days post-surgery
Change in Pain Scores from Baseline to 3 Days
Time Frame: 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).
3 days post-surgery
Change in Narcotic Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
Time Frame: 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
Change in Narcotic Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
Time Frame: 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
Change in Narcotic Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
Time Frame: 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
Change in Narcotic Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
Time Frame: 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
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
Time Frame: 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
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
Time Frame: 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
Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
Time Frame: 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
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 3 Months Post-Surgery
Time Frame: 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
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 30 Days Post-Surgery
Time Frame: 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
Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 14 Days Post-Surgery
Time Frame: 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
Operative Time
Time Frame: Intra-operative
Operative time, defined as first incision to closure of the incision
Intra-operative
Length of Hospital Stay (LOS)
Time Frame: 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
Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week
Conversion to Open
Time Frame: Intra-operative
Incidence of conversions of the laparoscopic or robotic-assisted procedure
Intra-operative
Number of Complications
Time Frame: Intra-operative through the 3 month follow-up period
Intra-operative or post-operative complications related to the inguinal hernia repair
Intra-operative through the 3 month follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISI-IHP-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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