ClinicalTrials.gg
Status unknownNCT03395821SIMUTECUpdated Jan 10, 2018

Traditional Versus Virtual Reality for Surgical Skills for ObGyn Residents

An interventional study of Conventional training and Virtual Reality+conventional training in Gynecologic Disease, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 24 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-10.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
24 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gynecologic Disease

Keywords

  • competency-based education
  • gynecology
  • laparoscopy
  • resident education
  • simulation
  • surgical curriculum
03

In context

Genital Diseases, Female

161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.

This study's planned enrollment of 24 is below the median of 78 across 119 interventional studies indexed under Genital Diseases, Female.

Browse Genital Diseases, Female studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • refuse to participate
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    Conventional training

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

    Behavioral: Conventional training

  • 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

Interventions

  • BehavioralConventional training

    traditional training according to residency program

  • BehavioralVirtual Reality+conventional training

    virtual reality training+traditional training using virtual reality

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • HCPA
    Porto Alegre, RS 90035-903, Brazil
    Recruiting
08

References and documents

Publications

  • 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 Pt 1):1046-50. doi: 10.1111/j.1440-1746.2008.05457.x. Epub 2008 Jun 28. PubMed 18554236 ↗
  • 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.0000000000000254. PubMed 24503910 ↗
  • 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: 10.1016/j.ajog.2016.04.037. Epub 2016 Apr 27. PubMed 27131588 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Dec 2018, 11 months after the start.

Of 55 non-industry interventional studies with no phase under Genital Diseases, Female, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's planned 11 months is below that.

Counting every sponsor, half of 65 studies reached it within 14 months; a quarter within 8 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 27, 2017
First posted
Jan 10, 2018
StartActual
Dec 22, 2017
Primary completionEst.
Dec 1, 2018
CompletionEst.
Dec 1, 2018
Last update
Jan 10, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03395821
Responsible party
Ricardo Francalacci Savaris (Professor, Hospital de Clinicas de Porto Alegre) — Principal investigator
First posted
Jan 10, 2018
Start date
Dec 22, 2017
Primary completion
Dec 1, 2018 (estimated)
Completion
Dec 1, 2018 (estimated)
Last update
Jan 10, 2018

Study contacts

Guilherme G Pretto, MD,PhD
Contact
gpretto@hcpa.edu.br
+1(51)33597938
Ricardo F Savaris, MD,PhD
Contact
rsavaris@hcpa.edu.br
+1(51)33598117
Leandro T Cavazzola, MD,PhD
study chair · Hospital de Clínicas de Porto Alegre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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