Simulation for Preparation of Robotic Surgery Clinical Trial
Official title:
Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery
| Verified date | May 2016 |
| Source | Atlantic Health System |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The objective of this study is to determine whether a group of resident physicians otherwise naïve to robotic surgery can demonstrate equal levels of proficiency during their first robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer or the daVinci Skills Simulator.
| Status | Terminated |
| Enrollment | 0 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Obstetrics and gynecology or general surgery residents in ACGME accredited programs naïve to robotic surgery training - Completion of the online orientation to daVinci Surgical System Exclusion Criteria: - Performance of any robotic surgical procedures as the console surgeon - Performance of any robotic simulator protocols - Any significant amount of time spent on a virtual reality robotic simulator |
Allocation: Randomized, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| United States | Morristown Medical Center | Morristown | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Atlantic Health System |
United States,
Culligan P, Gurshumov E, Lewis C, Priestley J, Komar J, Salamon C. Predictive validity of a training protocol using a robotic surgery simulator. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):48-51. doi: 10.1097/SPV.0000000000000045. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Operative Time | Operative time will be measured by time elapsed between first grasp of the uterine fundus with the robotic single tooth tenaculum until amputation of the specimen at the internal cervical os. | at time of supracervical hysterectomy | No |
| Secondary | Estimated Blood Loss | As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume. | during the surgical procedure | Yes |
| Secondary | Surgical Skill Rating | As measured by the global assessment tool for evaluation of intraoperative laparoscopic skills (GOALS) tool via video assessment. These ratings will be performed by a group of surgeons who are not involved in the study and are masked as to the identity of the study surgeons. | following completion of the procedure | No |
| Secondary | Continued success with robotic surgery after participation in the study | The number of cases each participating resident performs as primary surgeon the 12 months after completion of the study will be recorded | during the 12 months following surgical procedure | No |