Biliary Colic, Cholecystitis
Conditions
Keywords
Robotic Surgery
Brief summary
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. Patients randomly 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 the same timeframe.
Interventions
DEVICESenhance Assisted Cholecystectomy
Cholecystectomy performed using Senhance surgical robotic system
PROCEDURELaparoscopic Cholecystectomy
Standard laparoscopic cholecystectomy
Sponsors
Imperial College London
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs
Exclusion criteria
Patients unable tor unwilling to consent BMI \>40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operative Time | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Morbidity Data | 30 days |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Senhance Cholecystectomy Cholecystectomy operation performed using Senhance robotic system
Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system | 20 |
| Laparoscopic Cholecystectomy Cholecystectomy operation performed using standard laparoscopic instruments
Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Laparoscopic Cholecystectomy | Total | Senhance Cholecystectomy |
|---|---|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 12.2 | 46 years STANDARD_DEVIATION 12 | 45.9 years STANDARD_DEVIATION 13 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 17 Participants | 34 Participants | 17 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 3 / 20 | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Operative Time
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Senhance Cholecystectomy | Operative Time | 86.5 minutes |
| Laparoscopic Cholecystectomy | Operative Time | 31.5 minutes |
Secondary
Morbidity Data
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Senhance Cholecystectomy | Morbidity Data | 3 Participants |
| Laparoscopic Cholecystectomy | Morbidity Data | 5 Participants |