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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03130530

Enrollment

Registered

2017-04-26

Start date

2015-06-01

Completion date

2016-09-30

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery

Keywords

robotic, colorectal, surgery

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Evaluation adverse events	from the surgery up to 30 days after the surgery	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

Secondary

Measure	Time frame	Description
Duration of hospitalisation	from surgery to hospital discharge, up to 30 days	Duration of hospitalisation
Duration of surgery	from to the start to the end of the surgery	Duration of surgery
Setup for surgery - collision rate	from to the start to the end of the surgery	Registration and calculation of the collision rate
Setup for surgery - reduced mobility	from to the start to the end of the surgery	Registration and calculation of the reduced mobility of the tools
Adverse events	Up to 30 days post-surgery	Number of adverse events

Outcome results