Validation Study for Robotic Surgery Simulator
調査の概要
詳細な説明
Objective: To determine whether a group of surgeons otherwise naive to robotic techniques could demonstrate proficiency during their first robotic supracervical hysterectomy having only received simulator and pig lab training.
Primary outcome measure: As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation.
Secondary Outcome measures:
- Blood loss- as measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.
- Surgical skill rating- All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet.
- Surgeon console biometrics- As measured by controller movements and grips
- Novice robotic surgeon data: Descriptive Operative data of surgeons who did not participate in robotic simulator training.
Methods: To create the simulator protocol, 5 robotic surgeons (each averaging >75 robotic cases per year) performed all 28 simulation modules available on the da Vinci Skills Simulator. To establish "expert benchmarks", they picked the 10 simulator modules they thought were most beneficial to robotic novices', and they performed each of these 10 modules to the best of their ability >5 times. The data was used to create benchmarks in which all parameters of these 10 modules were taken into account (i.e. not just the time to completion). Thus the "Morristown Protocol" was established- whereby successful completion of the protocol required passing every parameter of all 10 simulator modules at the expert level.
We then recruited community board-certified OB-GYN's who were completely naive to robotics and offered them full robotic training free-of-charge as long as they could pass the "Morristown Protocol" as their very first step in the training process. These "study surgeons" were given 24/7 access to the da Vinci Skills Simulator and simply asked to complete the protocol at their own pace. Within a week of doing so, they went through the standardized Intuitive Surgical pig lab and then performed their first ever robotic surgery- a supracervical hysterectomy- as our main outcome measure. These cases were performed using the dual-console daVinci system with one of the senior authors on the other console ready to step in if necessary.
Two sets of comparative benchmarks for this surgical procedure has been established. Our "expert surgeons" each performed supracervical hysterectomies for the study- as did a group of "control surgeons". These "control surgeons" had full robotic privileges but were not averaging more than 2 cases per month and had never used the simulator. Operative time, EBL, and a blinded skill assessment (of videos) were compared for all cases among the 3 surgeon groups using t-tests.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
New Jersey
-
Morristown、New Jersey、アメリカ、07960
- Morristown Medical Center
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Must not have performed a da Vinci assisted surgery
Exclusion Criteria:
- prior experience on the da Vinci system or the robotic simulator
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Expert Surgeons
Gynecologic robotic surgeons, each averaging >75 robotic cases per year
|
All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
|
|
Study Surgeons
Gynecologic surgeons who are completely naive to robotics
|
All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
|
|
Control Surgeons
Gynecologic surgeons with full robotic privileges but were not averaging more than 2 cases a month and had never used the simulator
|
All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Surgical Time
時間枠:At end of cervical amputation
|
As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation
|
At end of cervical amputation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood Loss
時間枠:End of cervical amputation
|
As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume
|
End of cervical amputation
|
|
Surgical Skill Rating
時間枠:Within a month of the performed surgery
|
All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet
|
Within a month of the performed surgery
|
|
Surgeon Console Biometrics
時間枠:during surgery
|
As measured by controller movements and grip
|
during surgery
|
|
Novice Robotic Surgeon Data
時間枠:Within a month of the performed surgery
|
Descriptive Operative data of surgeons who did not participate in robotic simulator training
|
Within a month of the performed surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Charbel Salamon, MD、Atlantic Health System
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- R11-01-018
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。