Traditional Versus Virtual Reality for Surgical Skills for ObGyn Residents

Gynecologic Disease Clinical Trial

— SIMUTEC  

Official title:

Comparison Between Exclusive Surgical Training Versus Virtual Reality Plus Traditional Training in Surgical Skills of Residents of Obstetrics and Gynecology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03395821
• Other study ID #: 17-0365
• Status: Recruiting
• Phase: N/A
• First received: December 27, 2017
• Last updated: January 4, 2018
• Start date: December 22, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Guilherme G Pretto, MD,PhD
• Phone: +1(51)33597938
• Email: gpretto[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will verify if a comprehensive laparoscopic curriculum using virtual reality demonstrates skills transfer to the operating room, compared to the traditional teaching method.

Description:

Second-year residents from different programs of residency in obstetrics and gynecology in Porto Alegre, RS, Brazil, will be invited to participate in this study. they will be randomized to receive a comprehensive training in laparoscopy using modern virtual reality program or the traditional method of training according to their residency program. After 12 weeks of training, they will finish their training and they will perform advanced laparoscopic surgery in the simulator according to their specific needs, for example, salpingectomy, oophorectomy advanced laparoscopic suture or hysterectomy. Data generated from the simulator program will be compared between groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years and older

Eligibility

Inclusion Criteria:

• residents in obstetrics and gynecology that are about to finish their second-year program

Exclusion Criteria:

• refuse to participate

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

Behavioral:
• Conventional training
traditional training according to residency program
• Virtual Reality+conventional training
virtual reality training+traditional training using virtual reality

Locations

Country	Name	City	State
Brazil	HCPA	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Palter VN, Grantcharov TP. Individualized deliberate practice on a virtual reality simulator improves technical performance of surgical novices in the operating room: a randomized controlled trial. Ann Surg. 2014 Mar;259(3):443-8. doi: 10.1097/SLA.0000000 — View Citation

Shirai Y, Yoshida T, Shiraishi R, Okamoto T, Nakamura H, Harada T, Nishikawa J, Sakaida I. Prospective randomized study on the use of a computer-based endoscopic simulator for training in esophagogastroduodenoscopy. J Gastroenterol Hepatol. 2008 Jul;23(7 — View Citation

Shore EM, Grantcharov TP, Husslein H, Shirreff L, Dedy NJ, McDermott CD, Lefebvre GG. Validating a standardized laparoscopy curriculum for gynecology residents: a randomized controlled trial. Am J Obstet Gynecol. 2016 Aug;215(2):204.e1-204.e11. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency of technical skills (%)	The software analyzes the percentage of time the needle-holders' ends are kept outside the operative field (%); total number of entrance and exit points through which the needle has passed; total aggressive tissue handling; total amount of strain applied to tissue during needle passages; total needle loading time; total number of completed knots; total number of needle loadings; total number of needle passages; total number of stitches; total time the needle-holders' ends are kept outside the predefined operative field; total time to accomplish the suture; Total time to form a knot. For salpingectomy: efficiency of cautery (%); number of non-cauterized bleeding; number of serious complications: possible damage to vital structures; safe cautery (%); the time cautery is applied without appropriate contact with adhesions; total number of applied clips.	12 weeks