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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074200
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Inguinal Hernia Procedure: Open Inguinal Hernia Repair Procedure: Laparoscopic Inguinal Hernia Repair Device: 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PREPARE: A PRospective Evaluation of Pain After Inguinal Hernia REpair
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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

  6. 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

  7. 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

  8. 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


Secondary Outcome Measures :
  1. 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

  2. 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. 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

  4. 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

  5. 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).

  6. 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).

  7. 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).

  8. Operative Time [ Time Frame: Intra-operative ]
    Operative time, defined as first incision to closure of the incision

  9. 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

  10. Conversion to Open [ Time Frame: Intra-operative ]
    Incidence of conversions of the laparoscopic or robotic-assisted procedure

  11. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074200


Contacts
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Contact: Alison Gorski 4085231855 alison.gorski@intusurg.com

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jill Janssen    615-343-8010    clinicaltrialscenter@vanderbilt.edu   
Principal Investigator: Richard Pierce, MD         
Sponsors and Collaborators
Intuitive Surgical
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Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT04074200    
Other Study ID Numbers: ISI-IHP-2018
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal