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Trial record 5 of 1550 for:    Recruiting, Not yet recruiting, Available Studies | "Genital Diseases, Female"

Traditional Versus Virtual Reality for Surgical Skills for ObGyn Residents (SIMUTEC)

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ClinicalTrials.gov Identifier: NCT03395821
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ricardo Francalacci Savaris, Hospital de Clinicas de Porto Alegre

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : December 22, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   24 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • refuse to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395821


Contacts
Contact: Guilherme G Pretto, MD,PhD +1(51)33597938 gpretto@hcpa.edu.br
Contact: Ricardo F Savaris, MD,PhD +1(51)33598117 rsavaris@hcpa.edu.br

Locations
Brazil
HCPA Recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: RICARDO F SAVARIS, MD,PHD       rsavaris@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Chair: Leandro T Cavazzola, MD,PhD Hospital de Clínicas de Porto Alegre

Publications of Results:
Responsible Party: Ricardo Francalacci Savaris, Professor, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03395821     History of Changes
Other Study ID Numbers: 17-0365
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ricardo Francalacci Savaris, Hospital de Clinicas de Porto Alegre:
competency-based education
gynecology
laparoscopy
resident education
simulation
surgical curriculum

Additional relevant MeSH terms:
Genital Diseases, Female