NCT02238743

Assuring and Defining Outcomes Through Procedural Training Using a Proctorship Model That Collects Patient Outcomes A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.

A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair.

Detailed description

The ADOPT- Ventral Hernia project is designed as a prospective, single arm, case series. The proctor will select a limited number of licensed surgeon trainees (up to 5) as agreed upon by Covidien and the proctor. The proctor will then train through clinical immersions, hands on proctorship and video training for proper technique on minimally invasive surgical (MIS) repair of ventral hernia. After the training, the data will be collected on the trainee's next 10 MIS ventral hernia repair cases, pending subject consent to collect data. Procedural and Post-Operative details will be captured for each of these subjects who have undergone the laparoscopic ventral hernia repair.

Conditions

• Hernia

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-09-12
• Last updated: 2016-07-26

Locations

1 site across 1 country: United States