Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
Phase: NA
Conditions: Biliary Colic, Cholecystitis
Sponsor: Imperial College London

 
 
 
 
 
 
 
Initial Experience with a new laparoscopic 
based robotically assisted surgical system for 
cholecystectomy 
 
 
NCT03380572 
 
 
 
31st January 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
INTRODUCTION 
A laparoscopic approach to cholecystectomy was introduced in the late 1980s and very quickly was 
established as a feasible alternative to open cholecystectomy [1]. Today, laparoscopic 
cholecystectomy is the gold standard of care for symptomatic cholelithiasis [2]. Usually, laparoscopic 
cholecystectomy is performed through 4 small incisions, however single incision laparoscopic 
surgery (SILS) has also been demonstrated to be safe [3]. 
Cholecystectomy performed robotically via the da Vinci Surgical System (Intuitive Surgical Inc., 
Sunnyvale, CA, USA) has been described using a multi-port system [4] and a single port system [5]. 
Robotic surgery addresses many limitations of laparoscopy including enhanced dexterity, 
ergonomics and visualization [6]. However, disadvantages include added time per case and 
increased cost [7]. 
The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, 
Morrisville, 
NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater 
accuracy, dexterity and control with similar operational costs to traditional laparoscopy [8]. 
The device is a multi-port system with independent robotic arms that replicate familiar laparoscopic 
instrument motion. These arms are controlled from a console where the primary surgeon sits (fig 1). 
The console provides the surgeon with 3D-HD vision on the screen, as well as an infrared eyetracking 
system that enables the surgeon to control the movement of the laparoscopic camera by 
focusing their gaze on different areas of the monitor. The surgeon receives haptic force feedback 
through the handles in the console, restoring the tissue reaction forces experienced in standard 
laparoscopy. 
The system utilizes reusable instruments that are similar to standard 5mm laparoscopic instruments 
with very minimal disposables. This design allows for the use of standard off the shelf trocars and 
commercially available accessories such as electrosurgical units. 
The first clinical experiences in gynecological surgery [9-12] and colorectal surgery [13] were 
recently 
published demonstrating that the system was feasible and safe. To date, no data have been 
published about the use of Senhance™ on cholecystectomy. 
This research describes the initial, single surgeon experience evaluating feasibility and safety of 
Senhance™ to perform cholecystectomy. The technique is described including robotic arm and port 
placement. Clinical outcomes and operative times of the first 20 cases performed at the center are 
described. These results are compared to a concurrently collected group of patients undergoing 
cholecystectomy using a standard four port laparoscopic technique. 
Materials and Methods 
Robotic set up 
The Senhance™ Surgical System (shown in Figure 1) has up to four independent manipulator arms 
that can be positioned around the operating table. For this series, only three arms were used and 
positioned around the operating room table as shown in Figure 2. We altered our traditional port 
placement slightly and used a 12mm trocar at the umbilicus for the camera, a 12mm trocar in the 
left upper quadrant and a 5mm trocar in the right upper quadrant of the abdomen in order to avoid 
interference of the manipulator arms. A further 5mm trocar was inserted laterally in the right flank 
for manual retraction of the gallbladder fundus (see Fig 3). 
The Senhance™ System has a selection of standard laparoscopic instruments and in this series a 
310mm L hook monopolar electrode was used in the right port and a grasper in the left for the 
majority of the operation. A LigaMAXä5 (Ethicon, Somerville, NJ, USA) clip applier was deployed 
by 
the assistant surgeon at the bedside through the left port to clip the cystic duct and artery. Figure 3 
shows the port placement used in this series. 
Patient recruitment and data analysis 
Patients received either a standard laparoscopic cholecystectomy or the Senhance™ assisted 
cholecystectomy based on scheduled surgery date. A prospectively maintained database of the first 
20 patients undergoing cholecystectomy with the Senhance™ Surgical System was retrospectively 

 
interrogated and compared to a concurrently treated group of 20 laparoscopically treated patients 
during a similar timeframe performed by the same surgeon and theatre team. 
The Senhance™ Surgical System was passed through the new interventional procedures committee 
(NIPCOM) at the hospital and was sanctioned for use in a clinical environment. Formal ethical 
approval was not required for this pilot study. 
All patients were consented for surgery and for inclusion of their data into the hospital database. All 
patients were scored for anesthesia score by the attending anesthesiologist. The technical difficulty 
of each operation was graded (scale 1-3) by the consultant in accordance with predefined criteria as 
described in [14]. All operations were performed by a single surgeon (SP) and the same team at a 
central London teaching hospital. The surgeon has performed over 1000 laparoscopic 
cholecystectomies with only one converted to open during his career. 
Surgery duration was collected as both total operative time and console time (Senhance™ cohort 
only). By subtracting out console time from the total operative time, the efficiency of the operating 
theatre staff could be assessed. Console time is the surrogate for primary surgeon learning curve. 
Other operative details were collected including BMI of the patient, estimated blood loss (EBL) as 
well as any adverse events. 
All patients were reviewed in clinic 7 days post operatively and were monitored remotely for up to 
30 days to collect complication data. 
These methods are further described on the clinicaltrials.gov website (reference number 
NCT03380572). 
Data is summarized using standard summary statistics. For continuous data, results are summarized 
using mean and standard deviation if data are found to be normal via the Shapiro-Wilk test (p-value 
greater than 0.05). Otherwise median and interquartile (IQR) range are presented. For normally 
distributed data, the mean difference between cohorts and 95% confidence interval were assessed. 
Categorical data is summarized using counts and percentages. Reported differences between 
cohorts and associated 95% confidence intervals are based on exact methods. The data was 
analyzed using SAS software (SAS Institute, Cary, NC) Version 9.4.