Pain and Quality of Life After Inguinal Hernia Repair

CompletedOBSERVATIONAL
Enrollment

156

Participants

Timeline

Start Date

August 26, 2019

Primary Completion Date

July 6, 2023

Study Completion Date

July 6, 2023

Conditions
Inguinal Hernia
Interventions
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.

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.

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.

Trial Locations (1)

37232

Vanderbilt University Medical Center, Nashville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Intuitive Surgical

INDUSTRY

NCT04074200 - Pain and Quality of Life After Inguinal Hernia Repair | Biotech Hunter | Biotech Hunter