Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT03380572
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.7
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Colic; Cholecystitis	Device: Senhance Assisted Cholecystectomy; Procedure: Laparoscopic Cholecystectomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
• Actual Study Start Date: Feb 10, 2017
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Senhance Cholecystectomy Cholecystectomy operation performed using Senhance robotic system	Device: Senhance Assisted Cholecystectomy; Cholecystectomy performed using Senhance surgical robotic system
Active Comparator: Laparoscopic Cholecystectomy Cholecystectomy operation performed using standard laparoscopic instruments	Procedure: Laparoscopic Cholecystectomy; Standard laparoscopic cholecystectomy

Outcome Measures

Primary Outcome Measures

1. Operative Time [1 day]

Secondary Outcome Measures

1. Morbidity Data [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial College NHS Trust	London		United Kingdom	W2 1NY

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Sanjay Purkayastha, MD, Imperial College London

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 31, 2017

More Information

Publications

None provided.

• Responsible Party: Ravi Aggarwal, Clinical Research Fellow, Imperial College London
• ClinicalTrials.gov Identifier: NCT03380572
• Other Study ID Numbers: SenhanceChole
• First Posted: Dec 21, 2017
• Last Update Posted: May 21, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Ravi Aggarwal, Clinical Research Fellow, Imperial College London: Robotic Surgery
• Additional relevant MeSH terms: Cholecystitis

Study Results

Participant Flow

Arm/Group Title	Senhance Cholecystectomy	Laparoscopic Cholecystectomy
Arm/Group Description	Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system	Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Senhance Cholecystectomy	Laparoscopic Cholecystectomy	Total
Arm/Group Description	Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system	Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.9 (13)	48.4 (12.2)	46 (12)
Sex: Female, Male (Count of Participants)
Female	17 85%	17 85%	34 85%
Male	3 15%	3 15%	6 15%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Operative Time
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senhance Cholecystectomy	Laparoscopic Cholecystectomy
Arm/Group Description	Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system	Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy
Measure Participants	20	20
Median (Inter-Quartile Range) [minutes]	86.5	31.5

2. Secondary Outcome

Title	Morbidity Data
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senhance Cholecystectomy	Laparoscopic Cholecystectomy
Arm/Group Description	Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system	Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy
Measure Participants	20	20
Count of Participants [Participants]	3 15%	5 25%

Adverse Events

Time Frame	30 days
Arm/Group Title	Senhance Cholecystectomy		Laparoscopic Cholecystectomy
Arm/Group Description	Cholecystectomy operation performed using Senhance robotic system Senhance Assisted Cholecystectomy: Cholecystectomy performed using Senhance surgical robotic system		Cholecystectomy operation performed using standard laparoscopic instruments Laparoscopic Cholecystectomy: Standard laparoscopic cholecystectomy
All Cause Mortality
	Senhance Cholecystectomy		Laparoscopic Cholecystectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Senhance Cholecystectomy		Laparoscopic Cholecystectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Senhance Cholecystectomy		Laparoscopic Cholecystectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/20 (15%)		5/20 (25%)
Blood and lymphatic system disorders
Bleeding	1/20 (5%)	1	0/20 (0%)	0
General disorders
Pain	1/20 (5%)	1	1/20 (5%)	1
Hepatobiliary disorders
Bile leak	0/20 (0%)	0	1/20 (5%)	1
Skin and subcutaneous tissue disorders
Wound infection	1/20 (5%)	1	3/20 (15%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.