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Clinical Trials/NCT03395821
NCT03395821UnknownNot Applicable

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

Hospital de Clinicas de Porto Alegre1 site in 1 country24 target enrollmentStarted: December 22, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
24
Locations
1
Primary Endpoint
Efficiency of technical skills (%)

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
24 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Conventional training

Active Comparator

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

Intervention: Conventional training (Behavioral)

Virtual Reality+conventional training

Experimental

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

Intervention: Virtual Reality+conventional training (Behavioral)

Outcomes

Primary Outcomes

Efficiency of technical skills (%)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ricardo Francalacci Savaris

Professor

Hospital de Clinicas de Porto Alegre

Study Sites (1)

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