Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03135080
Status:
COMPLETED
Last Update Posted:
2018-03-15
First Post:
2017-04-11
Brief Title:
The Effect of Long-Term HEAD START Training on Surgical Skill Levels
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
The Effect of Long-Term HEAD START Training on Surgical Skill Levels
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The research group developed a surgical simulation device the Human Eyelid Analogue Device for Surgical Training And skill Reinforcement in Trachoma HEAD START to bridge the gap between classroom and live-surgery training specifically for trichiasis surgery In most settings HEAD START is utilized once during training then surgeons move on to live surgery and typically do not return to the simulator The research team is interested in determining whether HEAD START provides benefit for long-term trichiasis surgery training since many surgeons operate seasonally with long periods of downtime between surgical camps and with little field supervision
Participating surgeons will practice on HEAD START weekly with monthly feedback from a senior supervisor Researchers will assess their skill level at the start of HEAD START training and again at the start of the new surgical season in the fall of 2017 Researchers will also administer questionnaires to elicit feedback on the HEAD START training and supervision process
Participating surgeons will practice on HEAD START weekly with monthly feedback from a senior supervisor Researchers will assess their skill level at the start of HEAD START training and again at the start of the new surgical season in the fall of 2017 Researchers will also administer questionnaires to elicit feedback on the HEAD START training and supervision process
Detailed Description:
Eliminating blinding trachoma by 2020 is a key goal of the World Health Organization WHO Nearly 8 million individuals worldwide are in need of trichiasis surgery to prevent blindness1 Currently many trichiasis surgery programs experience poor outcomes in 10-50 of patients2-11 High-quality surgery with minimal post-operative trichiasis is critical for success of the WHO goals Typically non-physician surgeons perform the procedure Historically they have been provided with one-week of classroom training and then begin live surgery training
The research group developed a surgical simulation device the Human Eyelid Analogue Device for Surgical Training And skill Reinforcement in Trachoma HEAD START to bridge the gap between classroom and live-surgery training specifically for trichiasis surgery Based on this work the WHO now recommends that all trainees receive training with a surgical simulation device before performing live surgery and that any refresher training should include simulation training as well
In most settings HEAD START is utilized once during training meaning that once individuals are trained on HEAD START they move on to live surgery and typically do not return to the simulator In surgical sub-specialties with ready access to simulation devices regular surgical simulation practice is utilized for skills maintenance and enhancement The research team is interested in determining whether HEAD START provides benefit for long-term trichiasis surgery training since many surgeons operate seasonally with long periods of downtime between surgical camps and with little field supervision
This project will compare skills of surgical trainees who continued with HEAD START practice and feedback throughout a 6-month break in surgery with those who did not Study subjects will be selected based on their participation in an ORBIS-sponsored trichiasis surgery training program either new training or refresherconversion training At the end of the standard training the trainees who successfully complete training are ranked according to their scores on a classroom-based test and the WHO certificationassessment form All individuals who successfully complete the training session and are scheduled to begin independent trichiasis surgery practice through the National Eye Care Program will be invited to participate in the study until we have reached 30 participants Fifteen trainees will be invited to participate in long-term HEAD START practice in addition to performing regular live surgery An additional 15 individuals will be selected for the trainer to assess their skill levels on live surgery at the end of training and again at the start of the surgical season this fall
The research group developed a surgical simulation device the Human Eyelid Analogue Device for Surgical Training And skill Reinforcement in Trachoma HEAD START to bridge the gap between classroom and live-surgery training specifically for trichiasis surgery Based on this work the WHO now recommends that all trainees receive training with a surgical simulation device before performing live surgery and that any refresher training should include simulation training as well
In most settings HEAD START is utilized once during training meaning that once individuals are trained on HEAD START they move on to live surgery and typically do not return to the simulator In surgical sub-specialties with ready access to simulation devices regular surgical simulation practice is utilized for skills maintenance and enhancement The research team is interested in determining whether HEAD START provides benefit for long-term trichiasis surgery training since many surgeons operate seasonally with long periods of downtime between surgical camps and with little field supervision
This project will compare skills of surgical trainees who continued with HEAD START practice and feedback throughout a 6-month break in surgery with those who did not Study subjects will be selected based on their participation in an ORBIS-sponsored trichiasis surgery training program either new training or refresherconversion training At the end of the standard training the trainees who successfully complete training are ranked according to their scores on a classroom-based test and the WHO certificationassessment form All individuals who successfully complete the training session and are scheduled to begin independent trichiasis surgery practice through the National Eye Care Program will be invited to participate in the study until we have reached 30 participants Fifteen trainees will be invited to participate in long-term HEAD START practice in addition to performing regular live surgery An additional 15 individuals will be selected for the trainer to assess their skill levels on live surgery at the end of training and again at the start of the surgical season this fall
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None