Pain and Quality of Life After Inguinal Hernia Repair

NCT ID: NCT04074200

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2023-07-06

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.

Conditions

Inguinal Hernia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Open Inguinal Hernia Repair

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

Open Inguinal Hernia Repair

Intervention Type: 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.

Laparoscopic Inguinal Hernia Repair

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

Laparoscopic Inguinal Hernia Repair

Intervention Type: 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.

Robotic-assisted Inguinal Hernia Repair

These subjects will undergo an inguinal hernia repair using a robotic-assisted surgical approach.

Robotic-Assisted Inguinal Hernia Repair

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intuitive Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

ISI-IHP-2018

Identifier Type: -

Identifier Source: org_study_id