Trial Outcomes & Findings for Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy (NCT NCT03380572)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

1 day

Results posted on

2019-05-21

Participant milestones
Measure	Senhance Cholecystectomy Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system	Laparoscopic Cholecystectomy Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Senhance Cholecystectomy n=20 Participants Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system	Laparoscopic Cholecystectomy n=20 Participants Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy	Total n=40 Participants Total of all reporting groups
Age, Continuous	45.9 years STANDARD_DEVIATION 13 • n=20 Participants	48.4 years STANDARD_DEVIATION 12.2 • n=20 Participants	46 years STANDARD_DEVIATION 12 • n=40 Participants
Sex: Female, Male Female	17 Participants n=20 Participants	17 Participants n=20 Participants	34 Participants n=40 Participants
Sex: Female, Male Male	3 Participants n=20 Participants	3 Participants n=20 Participants	6 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants

Timeframe: 1 day

Outcome measures
Measure	Senhance Cholecystectomy n=20 Participants Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system	Laparoscopic Cholecystectomy n=20 Participants Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy
Operative Time	86.5 minutes Interval 60.5 to 106.5	31.5 minutes Interval 26.0 to 41.0

Timeframe: 30 days

Outcome measures
Measure	Senhance Cholecystectomy n=20 Participants Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system	Laparoscopic Cholecystectomy n=20 Participants Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy
Morbidity Data	3 Participants	5 Participants

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Senhance Cholecystectomy n=20 participants at risk Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system	Laparoscopic Cholecystectomy n=20 participants at risk Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy
Skin and subcutaneous tissue disorders Wound infection	5.0% 1/20 • Number of events 1 • 30 days	15.0% 3/20 • Number of events 3 • 30 days
Hepatobiliary disorders Bile leak	0.00% 0/20 • 30 days	5.0% 1/20 • Number of events 1 • 30 days
Blood and lymphatic system disorders Bleeding	5.0% 1/20 • Number of events 1 • 30 days	0.00% 0/20 • 30 days
General disorders Pain	5.0% 1/20 • Number of events 1 • 30 days	5.0% 1/20 • Number of events 1 • 30 days

Imperial College London

Phone: 02033126840