NCT04074200

Pain and Quality of Life After Inguinal Hernia Repair

PREPARE: A PRospective Evaluation of Pain After Inguinal Hernia REpair

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 156 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-26
• Primary completion: 2023-07-06
• Completion: 2023-07-06
• First posted: 2019-08-29
• Last updated: 2024-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study