Traditional Versus Virtual Reality for Surgical Skills for ObGyn Residents (SIMUTEC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03395821|
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Disease||Behavioral: Conventional training Behavioral: Virtual Reality+conventional training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two groups will be compared according to their surgical skills.|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Contact: Guilherme G Pretto, MD,PhD||+1(51)firstname.lastname@example.org|
|Contact: Ricardo F Savaris, MD,PhD||+1(51)email@example.com|
|Porto Alegre, RS, Brazil, 90035-903|
|Contact: RICARDO F SAVARIS, MD,PHD firstname.lastname@example.org|
|Study Chair:||Leandro T Cavazzola, MD,PhD||Hospital de Clínicas de Porto Alegre|