Traditional Versus Virtual Reality for Surgical Skills for ObGyn Residents

NCT ID: NCT03395821

Last Updated: 2018-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-22

Study Completion Date

2018-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecologic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups will be compared according to their surgical skills.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional training

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

Group Type ACTIVE_COMPARATOR

Conventional training

Intervention Type BEHAVIORAL

traditional training according to residency program

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.

Group Type EXPERIMENTAL

Virtual Reality+conventional training

Intervention Type BEHAVIORAL

virtual reality training+traditional training using virtual reality

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional training

traditional training according to residency program

Intervention Type BEHAVIORAL

Virtual Reality+conventional training

virtual reality training+traditional training using virtual reality

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* refuse to participate
Minimum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ricardo Francalacci Savaris

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Leandro T Cavazzola, MD,PhD

Role: STUDY_CHAIR

Hospital de ClĂ­nicas de Porto Alegre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Guilherme G Pretto, MD,PhD

Role: CONTACT

+1(51)33597938

Ricardo F Savaris, MD,PhD

Role: CONTACT

+1(51)33598117

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

RICARDO F SAVARIS, MD,PHD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18554236 (View on PubMed)

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.

Reference Type RESULT
PMID: 24503910 (View on PubMed)

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.

Reference Type RESULT
PMID: 27131588 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17-0365

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Developing an Immersive Virtual Reality Platform
NCT07161141 NOT_YET_RECRUITING NA