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. (ADOPT)

July 25, 2016 updated by: Medtronic - MITG

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Determined by surgeon

Description

Inclusion Criteria:

  • Determined by surgeon's standard of care

Exclusion Criteria:

  • Determined by surgeon's standard of care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of complications during independent cases post proctorship
Time Frame: up to 30 days
collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • Principal Investigator: Jonathan Pearl, University of Maryland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project ADOPT- UM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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