N/A N=40 Single-blind Treatment

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

Biliary Colic · Cholecystitis

Bottom Line

View on ClinicalTrials.gov: NCT03380572 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Operative Time — 86.5; 31.5 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Senhance Assisted Cholecystectomy (Device); Laparoscopic Cholecystectomy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Operative Time	86.5; 31.5	—
SECONDARY Morbidity Data	3; 5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03380572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.