Gynecologic DiseaseSIMUTECNCT03395821
Traditional Versus Virtual Reality for Surgical Skills for ObGyn Residents
A study testing Conventional training and Virtual Reality+conventional training in people with Gynecologic Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 24 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Conventional training and Virtual Reality+conventional training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Dec 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- residents in obstetrics and gynecology that are about to finish their second-year program
Who cannot join
- refuse to participate
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
HCPA
Porto Alegre, Rio Grande do Sul, 90035-903
RICARDO F SAVARIS, MD,PHD, rsavaris@hcpa.edu.br
About this study
Official title: Comparison Between Exclusive Surgical Training Versus Virtual Reality Plus Traditional Training in Surgical Skills of Residents of Obstetrics and Gynecology
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.
- Conditions
- Gynecologic Disease
- Being tested
- Conventional training, Virtual Reality+conventional training
- Keywords
- competency-based education, gynecology, laparoscopy, resident education, simulation, surgical curriculum
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional trainingBehavioural
traditional training according to residency program
Virtual Reality+conventional trainingBehavioural
virtual reality training+traditional training using virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Conventional training | Active comparator | Residents will receive the traditional training for laparoscopic surgery according to their residency program. Receives: Behavioral: Conventional training |
| 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. Receives: Behavioral: Virtual Reality+conventional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start22 Dec 2017
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will be compared according to their surgical skills.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Francalacci Savaris, Hospital de Clinicas de Porto Alegre
- Investigators
- Leandro T Cavazzola, MD,PhD, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395821
- Sponsor's protocol ID
- 17-0365
- Acronym
- SIMUTEC
- Status last verified
- Dec 2017
- First submitted
- 27 Dec 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 18554236Palter 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 24503910Shore 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Exclusive Surgical Training Versus Virtual Reality Plus Traditional Training in Surgical Skills of Residents of Obstetrics and Gynecology
- ClinicalTrials.gov ID
- NCT03395821
- Acronym / sponsor ID
- SIMUTEC / 17-0365
- Conditions
- Gynecologic Disease
- Keywords
- competency-based education, gynecology, laparoscopy, resident education, simulation, surgical curriculum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups will be compared according to their surgical skills.
| Arm | Type | Receives |
|---|---|---|
| Conventional training | Active comparator | Behavioral: Conventional trainingResidents will receive the traditional training for laparoscopic surgery according to their residency program. |
| Virtual Reality+conventional training | Experimental | Behavioral: Virtual Reality+conventional trainingResidents will receive 12 weeks of virtual training for laparoscopy and their traditional training for laparoscopic surgery according to their residency program. |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- residents in obstetrics and gynecology that are about to finish their second-year program
Key exclusion criteria (1 listed)
- refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional trainingtraditional training according to residency program | Behavioural | Conventional training |
| Virtual Reality+conventional trainingvirtual reality training+traditional training using virtual reality | Behavioural | Virtual Reality+conventional training |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Results publication: PubMed 18554236Shirai 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.
- Results publication: PubMed 24503910Palter 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.
- Results publication: PubMed 27131588Shore 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.
- Individual participant dataSharing planned: No
Related trials for Gynecologic Disease
RecruitingObservational study
Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)
Gynecologic Cancer, Radiotherapy Side Effect
Not yet recruiting
ERAS Versus Conventional Care Following Gynecological Laparoscopic Surgery
Gynecologic Disease
RecruitingObservational study
Ultrasound Detection of Body Composition in Critical Care
Muscle Loss, Extracellular Fluid Alteration
Recruiting
ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
Enhanced Recovery After Surgery, Gynecologic Disease
Active, not recruitingPhase 1
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leandro T Cavazzola, MD,PhD study chair
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional training and Virtual Reality+conventional training in people with Gynecologic Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guilherme G Pretto, MD,PhD (+1(51)33597938, gpretto@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of technical skills (%) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03395821, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.