Pain and Quality of Life After Inguinal Hernia Repair

NCT04074200 | Completed FDA Device

• 1 other identifier: ISI-IHP-2018
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 7 Days Post-Surgery

  7 days post-surgery

• Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 3 Months Post-Surgery

  3 months post-surgery

• Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 30 Days Post-Surgery

  30 Days post-surgery

• Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 14 Days Post-Surgery

  14 Days post-surgery

• Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 3 Months Post-Surgery

  3 months post-surgery

Study Arms (3)

Open Inguinal Hernia Repair

These subjects will undergo an inguinal hernia repair using an open surgical approach.

Procedure: Open Inguinal Hernia Repair

Laparoscopic Inguinal Hernia Repair

These subjects will undergo an inguinal hernia repair using a laparoscopic surgical approach.

Procedure: Laparoscopic Inguinal Hernia Repair

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

Interventions

Open Inguinal Hernia Repair PROCEDURE

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.

Open Inguinal Hernia Repair

Laparoscopic Inguinal Hernia Repair PROCEDURE

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.

Laparoscopic Inguinal Hernia Repair

Robotic-Assisted Inguinal Hernia Repair DEVICE

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.

Robotic-assisted Inguinal Hernia Repair

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 29, 2019
• Study Start: August 26, 2019
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)