SIMUTEC: Traditional Versus Virtual Reality for Surgical Skills for ObGyn Residents

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT03395821

Collaborator

(none)

Enrollment

Location

Arms

11.3

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Disease	Behavioral: Conventional training Behavioral: Virtual Reality+conventional training	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups will be compared according to their surgical skills.Two groups will be compared according to their surgical skills.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 22, 2017

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional training Residents will receive the traditional training for laparoscopic surgery according to their residency program.	Behavioral: Conventional training traditional training according to residency program
Experimental: Virtual Reality+conventional training Residents will receive 12 weeks of virtual training for laparoscopy and their traditional training for laparoscopic surgery according to their residency program.	Behavioral: Virtual Reality+conventional training virtual reality training+traditional training using virtual reality

Arm

Intervention/Treatment

Active Comparator: Conventional training

Residents will receive the traditional training for laparoscopic surgery according to their residency program.

Behavioral: Conventional training

traditional training according to residency program

Experimental: Virtual Reality+conventional training

Residents will receive 12 weeks of virtual training for laparoscopy and their traditional training for laparoscopic surgery according to their residency program.

Behavioral: Virtual Reality+conventional training

virtual reality training+traditional training using virtual reality

Outcome Measures

Primary Outcome Measures

Efficiency of technical skills (%) [12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

refuse to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HCPA	Porto Alegre	RS	Brazil	90035-903

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

Study Chair: Leandro T Cavazzola, MD,PhD, Hospital de Clínicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ricardo Francalacci Savaris, Professor, Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT03395821

Other Study ID Numbers:

17-0365

First Posted:

Jan 10, 2018

Last Update Posted:

Jan 10, 2018

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ricardo Francalacci Savaris, Professor, Hospital de Clinicas de Porto Alegre

competency-based education

Study Results

No Results Posted as of Jan 10, 2018