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.

Hernia Clinical Trial

— ADOPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238743
• Other study ID #: Project ADOPT- UM
• Status: Completed
• Phase: N/A
• First received: August 21, 2014
• Last updated: July 25, 2016
• Start date: July 2014
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Determined by surgeon's standard of care

Exclusion Criteria:

• Determined by surgeon's standard of care

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complications during independent cases post proctorship	collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair	up to 30 days	No