Retrospective Study on Colorectal Robotic Surgery Results Obtained Using a New Robotic Platform

Colorectal Surgery Clinical Trial

Official title:

Retrospective Study on Colorectal Robotic Surgery Results Obtained Using a New Robotic Platform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130530
• Other study ID #: RETROSPECTIVE-2016
• Status: Completed
• Phase: N/A
• First received: April 19, 2017
• Last updated: April 21, 2017
• Start date: June 1, 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: April 2017
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The ALF-X (Advanced Laparoscopy through Force reflection) Robotic Surgery System is a medical device that is available for distribution in the EU (European Union) under CE Mark for use in general surgery, thoracic surgery, gynecological surgery and urological surgery. The main research question is to assess, from a retrospective poit of view, the safety and feasibility of this new robotic platform in the colorectal surgery.

Description:

The rationale of this study is to investigate the perioperative and the short term perioperative outcomes of this new robotic Platform in minimally invasive colorectal surgery. Tha ALF-X utilizes fully reusable along with haptic feedback and an innovative vision control system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients affected by colorectal disease (benign or malignant) having undergone surgery using ALF-X platform

Exclusion Criteria:

Related Conditions & MeSH terms

• Colorectal Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation adverse events	Adverse events occurred during the surgery and during the 30 days after the surgery evaluated using Clavien-Dindo Classification, conversion rate to traditional laparoscopy or open surgery	from the surgery up to 30 days after the surgery
Secondary	Duration of hospitalisation	Duration of hospitalisation	from surgery to hospital discharge, up to 30 days
Secondary	Duration of surgery	Duration of surgery	from to the start to the end of the surgery
Secondary	Setup for surgery - collision rate	Registration and calculation of the collision rate	from to the start to the end of the surgery
Secondary	Setup for surgery - reduced mobility	Registration and calculation of the reduced mobility of the tools	from to the start to the end of the surgery
Secondary	Adverse events	Number of adverse events	Up to 30 days post-surgery