COMPATIBLE
Chapter 10 臨床案例
Appendix A
一旦簽署同意書後，每位病人便隨機給予達文西系統手術或傳統手術。手術後的評量包括了 30 天 病歷觀察、健康檢查， 胃底摺疊術的病人還包括了esophageal manometery 及 24 小時的 pH 觀 察。
隨機化結果
隨機化選擇病人的設計為安排約一半執行達文西系統手術，另一半為傳統手術。在 245 個病歷 中，12 個病例 (7 個膽囊切除術及 5 個胃底摺疊術) 為訓練用，讓醫師及工作人員熟悉達文西系 統及手術室環境。其餘的233個病例則隨機被分配。共有 113 個病例執行膽囊切除術，其中 57 個 為實驗組，56 個為對照組。在 113 個病例中，有 3 個病例 (實驗組：2，對照組：1) 無法追蹤。
共有 120 個病例執行膽囊切除術，其中 60 個為實驗組，30 個為對照組。在 120 個病例中，有 12 個病例 (實驗組：6，對照組：6) 無法追蹤。無法追蹤的原因包括：搬家或拒絕參與追蹤的測 試。研究數據如表 1 及表 2。
表 1
膽囊切除術病例隨機化資料
病例數 (n) 實驗組 對照組
113 57 56
無法追蹤 2 1
1實驗組 = 達文西系統da Vinci System 2對照組 = 傳統腹腔鏡手術
表 2
Nissen 胃底摺疊術病例隨機化資料
病例數 (n) 實驗組 對照組
120 60 60
無法追蹤 6 6
1實驗組 = 達文西系統da Vinci System 2對照組 = 傳統腹腔鏡手術
併發症/反效果
在此次參與評量的 228 位病患中，56 位經歷了 peri-operative 或 post-operative 手術相關的併 發症。表 3 列出了併發症/反效果。其中並沒有達文西系統裝置引起的併發症，也沒有因內視鏡 手術而直接影響。發生的 peri-operative 併發症包括了膽汁溢出 (膽囊切除術)及因插入套管針或 使用harmonic解剖刀而導致組織或漿膜受傷 (胃底摺疊術對照組一人死亡)。Post-operative併發 症包括了吞嚥困難(dysphagia)及and wrap-migration (胃底摺疊術)，還有臍帶感染 (腹腔鏡手術 常見現象，通常與消毒不當，或暴露腹腔有關。總之，在併發症比例上，實驗組及對照組的差別 並不大。
表 3
反效果及併發症
實驗組 對照組 p-value
膽囊切除術n (%)
Bile Spillage 20/55 (36.4%) 17/55 (30.9%) 0.686
Trocar Injury 1/55 ( 1.8%) 1/55 (1.8%) 1.000
Serosal Injury 0/55 ( 0.0%) 2/55 ( 3.6%) 0.495
Infection 0/55 ( 0.0%) 1/55 ( 1.8%) 1.000
胃底摺疊術病n (%)
Dysphagia 3/60 ( 5.0%) 5/58 ( 8.6%) 0.487
Wrap Migration 2/60 ( 3.3%) 0/58 ( 0.0%) 0.496
Trocar Injury 0/60 ( 0.0%) 1/58 ( 1.7%) 0.492
Serosal Injury 1/60 (1.7%)3 2/58 ( 3.4%) 0.615
1實驗組 = 達文西系統da Vinci System 2對照組 = 傳統腹腔鏡手術
3Resulted in death 83 days post-operatively
手術轉換
兩個原本為實驗組病例，在使用達文西系統前決定轉換，使用傳統腹腔鏡手術，因此不包括在此 次的分析統計內。一個病例因有嚴重的腹膜發炎現象(peritoneal inflammation)及創傷
(scarring)，另一個病例則有結狀肝硬化 (nodular hepatic cirrhosis)，醫師決定用傳統手術。
結果分析
113 次使用達文西系統的手術 (55 次膽囊切除術 及 58 次 胃底摺疊術)，全部成功的完成，並不 需要轉換成傳統的腹腔鏡或腹腔手術。
表 4 列出分組累計的手術時數及手術程序。膽囊切除術 (137.4±60.4 v. 86.2±27.5 分鐘，
p<0.00001) 及 胃底摺疊術 (110.1±32.8 v. 66.9±25.0 分鐘，p<0.00001)裡，實驗組的時數較對 照組多，原因可能是新的達文西系統的學習曲線。
表 4 手術時數
實驗組 對照組 p-value
膽囊切除術(m)
Avg 110.1 66.9 0.00001
SD 32.8 25.0
n 55 55
Range 55-199 45-150
胃底摺疊術 (m)
Avg 137.4 86.2 0.00001
SD 60.4 27.5
n 58 60
Range 59-355 45-150
1實驗組 = 達文西系統da Vinci System 2對照組 = 傳統腹腔鏡手術
如表 5 所示，實驗組及對照組的手術內失血極小，實驗組病例內失血達 50 mL 較對照組為多 (膽 囊切除術：p=0.027，胃底摺疊術：p=0.031)，出血通常是因為使用套管針時組織受傷，或使用 harmonic scalpel。
表 5
實驗組 對照組 p-value 膽囊切除術n (%)
50 mL
49/55 (89.1%) 55/55 (100%) 0.027
胃底摺疊術 n (%) 50 mL
51/58 (87.9%) 59/60 (98.3%) 0.031
1實驗組 = 達文西系統da Vinci System 2對照組 = 傳統腹腔鏡手術
表 6 為107個病患手術前及手術後的 DeMeester scores (n=11 沒有手術後 DeMeester score).
DeMeester scores 手術後的數值明顯的降低，實驗組 (-62.7%, p<0.00001) 及對照組 (-62.8%, p<0.00001)，差別並不明顯(p=0. 922)。在 DeMeester score 降低的比例上，實驗組 (88.5%) 及 對照組(90.9%)，差別也不明顯(p=0.997)。手術後 Demeester score 小於 14.8的病患比例，實 驗組(73.1%) 及對照組 (74.5%)，差別也不大 (p=0.962)。
表 6
胃底摺疊術手術前手術後DeMeester Scores
手術前 手術後 差距 p-value
實驗組
Avg 132.0 27.9 -104.1 0.00001
SD 93.7 55.9 115.1
N 52 52 52
Range 14.9-334.5 0.3-214.3 -332.9 to 126.0 對照組
Avg 118.7 19.9 -98.8 0.00001
SD 89.5 52.3 108.3
N 55 55 55
Range 17.7-295.8 0.3-312.6 -29.2 to 198.8
1實驗組 = 達文西系統da Vinci System 2對照組 = 傳統腹腔鏡手術
如表 7 所示，大部分的病人在手術後住院 2 天。膽囊切除術實驗組及對照組的住院天數相差不 大，但 胃底摺疊術 的差別就比較顯著 ( 2 位病人住院天數分別為18 及83天)。除了這兩個病人 以外，住院在 2 天以下的比例仍然相當顯著。
表 7
手術後住院天數
實驗組 對照組 p-value
膽囊切除術n (%) 2 天
53/55 (96.4%) 55/55 (100%) 0.495
住院天數總和 71 61
胃底摺疊術 n (%) 2 天
54/58 (93.1%) 57/60 (95.0%) 0.715
住院天數總和 83 172
1實驗組 = 達文西系統da Vinci System 2對照組 = 傳統腹腔鏡手術
裝置故障及更換
在這次實驗中，並未發生裝置故障的情況。達文西系統成功地執行所有的手術。三個不同的系統 錯誤，分別中斷 12、13及20分鐘，達文西系統也依照所設計的功能，順利如軟體指示的轉換到 安全的狀況，且並未發生任何臨床的失誤。
風險/助益分析
達文西系統的功能包括了七度自由度的內視鏡器械肘、提高精確度及降低震動的動作幅度調整，
較傳統內視鏡器械多的明顯優勢。這些助益，因為達文西系統在安全與可靠度上的設計，超越了 電腦科技產品可能有的風險。
安全
在此次的研究中，並未發生裝置相關的失誤，因此也證明達文西系統能安全地執行所設計的功能。
效能
由達文西系統開始的手術都順利完成，並不需轉換成傳統腹腔鏡或腹腔手術。實驗組與對照組的 臨床結果與失誤率相仿。
總結，臨床研究的結果證明達文西系統能安全並有效地執行所設計的功能。
A
Accessories Cleaning 7-1
Sterilazation and Cleaning matrix 7-2 ALARM indicator 6-5
Alarms
Audible alarms 8-3 Alignment Target
Using for Calibration 3-9 Audio Intercom System Volume adjustment 6-11 Autoclave
Sterilization reference information 7-3 Auxiliary Instrument Arm
Assigning to a master 4-4 Collision Detection
Reference information 6-18 Disabling 6-8
Display information Stereo Viewer
Auxiliary Instrument Arm information 6-8
Excessive Force Detection Reference information 6-19 Moving along the Z-axis 6-17 Reference information 6-16 Swapping 4-5
Reference information 6-14 Using 4-4
B
Blade Protector 4-12
C
Calibrating the Endoscope and Camera 3-9 Calibration
TEST IMAGE button
Reference information 6-7
Using the TEST IMAGE button 3-9 Camera
Adjusting with the Camera Orientation Line 4-4
Attaching to the Camera Arm 4-17 Calibrating 3-9
Repositioning the Camera/Scope image 4-3 Camera Arm
Attaching the Camera Cannula Mount 3-6 Attaching the Sterile Camera Arm Adapter 3-7
Attaching/Removing the Camera/Endoscope 4-17
Cannula connection 4-7 Clutching 4-8
Draping 3-5 overview 1-5
Reference information 6-16 Removing the Cannula Mount 5-1
Removing the Sterile Camera Adapter 5-1 Camera Cannula Mount
Removing from the Camera Arm 5-1 CAMERA Foot Switch
Using to reposition the Camera/Scope image 4-3
Camera Head 3-7
Attaching to the endoscope 3-8 Camera Orientation Line
Using to adjust the camera 4-4
Camera Signal Loss indicator 6-4 Camera Sterile Adapter
Attaching to the endoscope 3-7 CANNULA button
Reference information 6-6
Selecting the Cannula Length 4-6 Cannula Mount
Attaching the Camera Cannula Mount 3-6 Attaching to instrument arms 3-4
Removing from the Instrument Arms 5-1 Cannulae
Attaching the Camera Cannula Mount 3-6 Attaching the Cannula Mount 3-4
Attaching to Instrument arms 3-4 Attaching Twist-lock Cannulae 3-4
Connecting the Camera Cannula to the Camera Arm 4-7
Connecting to the Instrument Arms 4-7 Inserting and Connecting 4-6
Selecting the Cannula Length 4-6 Cleaning 7-1
Accessories 7-1
Sterilazation and Cleaning matrix 7-2 Surgeon’s Console 7-1
Surgical Cart 7-1 Clip Appliers
Index-2 Intuitive Surgical, Inc.
P/N 550120-02 Rev XB
Loading and firing 4-15 CLUTCH Foot Switch
Using to reposition Masters 4-5 Using to swap instrument arms 4-5 Clutching
Camera clutching 6-15
Instrument and Camera arm clutching 4-8 Master Clutching
Reference information 6-14 CRITICAL ERROR indicator 6-5
D
da Vinci System Draping 3-1
General Overview 1-1–1-2
General setup procedures 2-1–2-6 Shutdown 5-1
Startup 2-5–2-6
Use during a procedure 4-1–4-17 DISPLAY button
Reference information 6-6 Draping 3-7
Attaching sterile adapters 3-2
Attaching the Sterile Camera Adapter 3-7 Camera Arm
3-5
Draping the Camera Head 3-7 Instrument arms 3-2
Reference information 6-19 Securing the drapes 3-5 Sequence 3-2
E
Emergency Grip Release 4-13 Emergency Power Off button Reference information 6-11 Emergency Stop
reference information 8-1 EMERGENCY STOP button 6-3 Emergency Stop mode 3-12
Endoscope
Attaching the Sterile Camera Adapter 3-7 Attaching to the Camera Arm 4-17
Attaching to the Camera Head 3-8 Calibrating 3-9
Repositioning the Camera/Scope image 4-3 Selecting the scope angle 4-2
Using the Alignment Target 3-9 Error Log
Viewing 8-4 Errors
Fault and Emergency Stop states 8-1 EtO
Sterilizition reference information 7-2
F
FAULT OVERRIDE button 6-5 Faults
Loss of Power 8-3 Non-recoverable 8-2 Recoverable 8-2
reference information 8-1 Focusing the video image 4-3 Follow mode 3-11
Foot Switches Camera 6-14 Clutch 6-14 Focus 6-15
G
Guided Tool Change 4-10
H
Head Sensor
Reference information 6-10 Homing 2-5
I
Icons
Reference information 6-12, 8-4–8-11 InSite Vision System
General overview Vision System
General Overview 1-6 Instrument Arms attaching cannulae 3-4 Clutching 4-8
Connecting cannulae 4-7 Draping 3-2
overview 1-4
Reference information 6-16 Removing sterile adapters 3-3 Removing the Cannula Mount 5-1
Intuitive Surgical, Inc. Index-3 P/N 550120-02 Rev XB
Removing the Sterile Adapters 5-1 Sterile Adapter compatibility 3-13 Swapping 4-5
Instruments 7-1
Automated insertion 4-10 Cleaning 7-1
Clip Appliers
Loading and firing 4-15 Emergency grip release 4-13
Limited Reuse and Expiration indication 6-22
Manual insertion 4-10 Placement and removal 4-9 Reference information 6-19–6-22 Removal 4-11
Scalpel blade insertion instructions 4-14 Tool Reader button 6-10
Tool Reader mode 4-14 Usage summary display 5-2 Using a blade protector 4-12
L
Loss of Power 8-3
M
Main circuit breakers 2-2 Masters
Assigning to Auxiliary Instrument Arm 4-4 Assigning to Instrument Arms
Reference information 6-7 Clutching 6-14
General overview 1-2
Repositioning during use 4-5 Swapping 4-5
Using to reposition the Camera/Scope image 4-3
Modes
Emergency Stop 3-12 Follow mode 3-11 Ready mode 3-10 Stand By mode 3-10
Understanding Operating Modes 3-10–3-12
O
Operating Modes 3-10–3-12
P
Port Locations Selecting 4-1
Power Loss indicator 6-4
R
READY button 2-6
Reference information 6-4 Ready mode 3-10
Remote Center
Reference information 6-16
S
SCALING button
Using to change scaling options 4-5 SCALING control
Reference information 6-5 Scalpel blades
Insertion instructions 4-14 SCOPE ANGLE button Reference information 6-5 using for calibration 3-9 SELECT MASTER buttons Reference information 6-7 Select Master buttons
Using to assign a master to an instrument arm 4-4
Selftest 2-5
Service Required indicator 6-4
Setting up the da Vinci System 2-1–2-6 Setup Joint
overview 1-4
Reference information 6-15 Shutdown process 5-3
Shutting down the system 5-1 SILENCE ALARM button 6-5 STAND BY button
Reference information 6-4 Stand By mode 3-10
Starting up the system 2-5–2-6
Startup
Homing the arms 2-5 READY button 2-6 Selftest 2-5
Start-up Sequence indicator 6-4 Stereo View
Index-4 Intuitive Surgical, Inc.
P/N 550120-02 Rev XB
Brightness and Contrast adjustment 6-11 Stereo Viewer
DISPLAY button 6-6
Focusing the video image 4-3 General Overview 1-2
Message and Icon locations Icons
Display locations 8-12
Switching from 3D to 2D 4-3 Sterile Accessories
Example 3-1 Preparing 3-1
Sterile Adapter compatibility matrix 3-13 Sterile Adapters
Attaching to drapes 3-2 Reference information 6-19 Removing 5-1
Removing from Instrument arm 3-3 Sterile Camera Adapter
Attaching to the Camera Head 3-8 Removing from Camera Arm 5-1 Sterile Camera Arm Adapter Attaching to Camera Arm 3-7 Sterilization
Autoclave
Reference information 7-3 Steris
Reference information 7-3 Sterrad
Reference information 7-3 Sterilizition
EtO
Reference information 7-2 Steris
Sterilization reference information 7-3 Sterrad
Sterilization reference information 7-3 Surgeon’s Console 7-1
Adjustment for comfort 4-2
Audio Intercom System volume adjustment 6-11
Brightness and Contrast adjustment 6-11 Controls and Indicators
General overview 1-2–1-3 Reference information 6-1–6-15 Emergency Power Off button 6-11 Focusing the video image 4-3 Foot Switches 6-14
General Overview 1-2 Head Sensor
Reference information 6-10
Intra-ocular Spacing Adjustment 6-11 Masters
General overview 1-2
Repositioning the Camera/Scope image 4-3 Selecting the endoscope angle 4-2
Setup procedures 2-1–2-2 Main breakers 2-2
Positioning 2-1 Startup 2-5–2-6 Stereo Viewer
General overview 1-2
Switching from 3D to 2D 4-3 User Interface Panel 6-2 User Switch Panel 6-2
Viewer Height adjustment 6-10 Surgical Cart
Camera Arm overview 1-5
Reference information 6-16
Cannula Insertion and Connection 4-6 Cleaning 7-1
General overview 1-4–1-5 Instrument Arms
overview 1-4
Reference information 6-16 Setup
Connecting system cables 2-2 Positioning 2-2
Setup Joint overview 1-4
Reference information 6-15 Startup 2-5–2-6
Symbols
Reference information 8-4–8-11 SYSTEM button
Reference information 6-3 Using for shutdown 5-3 System Status indicators Alarm 6-5
Critical Error 6-5
Fault Override 6-5 Silence Alarm 6-5
Intuitive Surgical, Inc. Index-5 P/N 550120-02 Rev XB
T
TEST IMAGE button
Reference information 6-7 Using for calibration 3-9 TOOL READER button Reference information 6-10 Tool Reader mode 4-14 Twist-lock Cannulae
Attaching to instrument arms 3-4
U
Usage Summary Display 5-2 User Interface Panel
Example 6-2 READY button 6-4 STAND BY button 6-4 Status Indicators
Camera Signal Loss 6-4 Power Loss 6-4
Service Required 6-4 Start-up Sequence 6-4 User Switch Panel
EMERGENCY STOP button 6-3 Example 6-2
SYSTEM button 6-3
V
Video image repositioning 4-3 Vision Cart Setup