Clinical Trials Logo
  1. Home
  2. Cholecystitis
  3. NCT03380572
  4. Details
NCT03380572 Clinical Trial

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

Cholecystitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03380572
Other study ID # SenhanceChole
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2017
Est. completion date January 1, 2018

Study information
Verified date May 2019
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 1, 2018
Est. primary completion date December 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Senhance Assisted Cholecystectomy
Cholecystectomy performed using Senhance surgical robotic system
Procedure:
• Laparoscopic Cholecystectomy
Standard laparoscopic cholecystectomy

Locations
Country Name City State
United Kingdom Imperial College NHS Trust London

Sponsors (1)
Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Operative Time 1 day
Secondary Morbidity Data 30 days
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03636841 - Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis N/A
Completed NCT02379780 - Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy N/A
Completed NCT01937104 - ONSD According to the Position During Laparoscopy N/A
Completed NCT02461147 - Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
Completed NCT02264444 - Establishing Visualization Grading Scale on LESS Cholecystectomy N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT00940264 - Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection. N/A
Completed NCT00746850 - Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis N/A
Completed NCT00370344 - Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease Phase 2/Phase 3
Completed NCT00195351 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Phase 4
Completed NCT02858986 - 3D Versus 4K Laparoscopic Cholecystectomy N/A
Completed NCT04602156 - US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy N/A
Completed NCT04942665 - Low Dose ICG for Biliary Tract and Tumor Imaging Phase 2
Completed NCT02547064 - Effect of Modified Stylet Angulation on the Intubation With GlideScope® N/A
Completed NCT00230971 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Phase 4
Completed NCT04122261 - A Clinical Study of Chinese Domestic Surgical Robot N/A
Completed NCT04716166 - Incentive Spirometry and Upper Abdominal Laparoscopic Surgery N/A
Completed NCT01476319 - Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department N/A
Withdrawn NCT02225418 - Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy N/A
Suspended NCT04306939 - Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study