NCT04855227

A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair

ASPIRE: A proSpective Evaluation of PaIn After Non-complex ventRal hErnia Repair

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 69 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.

Detailed description

This is a prospective, observational, study across robotic-assisted and laparoscopic primary (non-recurrent) umbilical and incisional hernia repair. The study aims to evaluate pain and QOL outcomes through 30 days. During the post-operative period through 30 days, pain medication intake, subject reported pain and quality of life and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
PROCEDURE	robotic-assisted ventral hernia repair	Laparoscopic ventral hernia repair With the subject under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the repair. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care. Robotic-assisted ventral hernia repair With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the subject and used to complete the procedure. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.

Timeline

• Start date: 2021-08-31
• Primary completion: 2024-11-04
• Completion: 2024-11-19
• First posted: 2021-04-22
• Last updated: 2024-12-19

Locations

1 site across 1 country: United States