- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05227430
Standardizovaná výuková videa z laparoskopických gynekologických operací (AA-GYNLAP)
Standardizovaná výuková videa laparoskopických gynekologických operací pro zlepšení chirurgického výkonu praktikantů chirurgie
Owing to coronavirus disease-related social distancing requirements, online education has gained prominence. Surgical trainers consider online videos as a useful teaching aid that maximizes trainees' learning and skill development given the backdrop of time constraints and productivity demands, however, online videos usually do not undergo a peer-review process. Based on these premises the LAP-VEGaS guidelines (LAParoscopic surgery Video Educational GuidelineS), a recommended checklist for production of educational surgical videos, were developed. This study aime to evaluate the impact of educational videos of laparoscopic gynecological surgeries, that were standardized with the LAP-VEGaS, for the improvement of surgical confidence and performance of surgical trainees.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Introduction Owing to coronavirus disease-related social distancing requirements, online education has gained prominence. Surgical trainers consider online videos as a useful teaching aid that maximizes trainees' learning and skill development given the backdrop of time constraints and productivity demands. YouTube has become the most commonly used online resource for educational material among residents, however, online videos usually do not undergo a peer-review process. Moreover, recent studies questioned the educational quality of YouTube laparoscopic hysterectomy videos.
Based on these premises the LAP-VEGaS guidelines (LAParoscopic surgery Video Educational GuidelineS), a recommended checklist for production of educational surgical videos, were developed by an international, multispecialty, joint trainers-trainees committee aiming to reduce the gap between surgeons' expectations and online resources' quality. The LAP-VEGaS VAT is considered valid and practical tool for assessing online laparoscopic operation videos. It assesses nine items. Every item scoring from 0 (item not presented in the video) to 2 (item extensively presented in the video) with a total marking score ranging from 0 to 18. Studies have reported highly accurate in identifying and selecting videos for acceptance for conference presentation and publication, with high level of internal consistency and generalizability. However, the question of how effectively standardized videos serve as quality influencing educational material remains unanswered. Additionally, date regarding its implication in gynecological laparoscopic interventions is limited.
Due to the aforementioned the aim of this study is to evaluate the impact of educational videos of laparoscopic gynecological surgeries, that standardized with the LAP-VEGaS, for the improvement of surgical confidence and performance of surgical trainees.
Material and Methods:
This a prospective study including residents at the beginning of gynecology round in two medical centers. Educational video tutorials of gynecological laparoscopic surgeries (Hysterectomy, Bilateral salpingo-oophorectomy (BSO), Bilateral salpingectomy) will be prepared following the LAP-VEGaS VAT standardization.
Residents in only one medical center will be asked to view the study educational videos (Study group). Residents in the other medical center will not receive the prepared video tutorials and will be free to use other modalities (Controls). Both groups will complete pre-operative questionnaire regarding their subjective self-evaluation of confidence in the stages of the procedures, instrumentation used, anatomy, potential risks and methods to control them. Additional post-operative questionnaire regarding performance during operation, familiarity with operative stages, anatomy and participants will be completed by the senior surgeon evaluating the resident and by all residents participating in the study. Data regarding residents' characteristics will be collected. Groups will be compared for differences in subjective confidence before surgery, performance during surgery and satisfaction rate.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Aya Mohr-Sasson, M.D
- Telefonní číslo: 3462704682
- E-mail: aya.mohrsasson@uth.tmc.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion criteria:
- Residents and fellows in OBGYN in their gynecological round
Exclusion criteria:
- Residents and fellows that did not complete module training for laparoscopic surgeries
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Surgical trainees
Surgical trainees that would be given educational video tutorials before entering gynecological laparoscopic surgeries |
Educational video tutorials (Hysterectomy, Bilateral salpingo-oophorectomy, Bilateral salpingectomy) |
|
Žádný zásah: Control
Surgical trainees that would not be given educational video tutorials before entering gynecological laparoscopic surgeries |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Performance evaluation by senior surgeon
Časové okno: At the end of the operation
|
Evaluated by the senior surgeon using the global rating scale of operative performance:7 questions rated between 1 (low performance) to 5(highly skilled) |
At the end of the operation
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Performance evaluation- evaluated by the trainee
Časové okno: At the end of the operation
|
valuated by the surgical trainee using the global rating scale of operative performance:7 questions rated between 1 (low performance) to 5(highly skilled) |
At the end of the operation
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Aya Mohr-Sasson, M.D, Aya Mohr-Sasson, Primary Investigator
Publikace a užitečné odkazy
Obecné publikace
- Unal F, Atakul N, Turan H, Yaman Ruhi I. Evaluation of YouTube laparoscopic hysterectomy videos as educational materials during the COVID-19 era using the LAParoscopic surgery Video Educational GuidelineS (LAP-VEGaS) and LAP-VEGaS video assessment tool. J Obstet Gynaecol. 2022 Jul;42(5):1325-1330. doi: 10.1080/01443615.2021.1962823. Epub 2021 Oct 27.
- Celentano V, Smart N, Cahill RA, Spinelli A, Giglio MC, McGrath J, Obermair A, Pellino G, Hasegawa H, Lal P, Lorenzon L, De Angelis N, Boni L, Gupta S, Griffith JP, Acheson AG, Cecil TD, Coleman MG. Development and validation of a recommended checklist for assessment of surgical videos quality: the LAParoscopic surgery Video Educational GuidelineS (LAP-VEGaS) video assessment tool. Surg Endosc. 2021 Mar;35(3):1362-1369. doi: 10.1007/s00464-020-07517-4. Epub 2020 Apr 6.
- Abdelsattar JM, Pandian TK, Finnesgard EJ, El Khatib MM, Rowse PG, Buckarma EN, Gas BL, Heller SF, Farley DR. Do You See What I See? How We Use Video as an Adjunct to General Surgery Resident Education. J Surg Educ. 2015 Nov-Dec;72(6):e145-50. doi: 10.1016/j.jsurg.2015.07.012. Epub 2015 Oct 9.
- Celentano V, Smart N, Cahill RA, McGrath JS, Gupta S, Griffith JP, Acheson AG, Cecil TD, Coleman MG. Use of laparoscopic videos amongst surgical trainees in the United Kingdom. Surgeon. 2019 Dec;17(6):334-339. doi: 10.1016/j.surge.2018.10.004. Epub 2018 Nov 9.
- Igwe E, Hernandez E, Rose S, Uppal S. Resident participation in laparoscopic hysterectomy: impact of trainee involvement on operative times and surgical outcomes. Am J Obstet Gynecol. 2014 Nov;211(5):484.e1-7. doi: 10.1016/j.ajog.2014.06.024. Epub 2014 Jun 17.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AA-GYNLAP
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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