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Completed

NCT Number: NCT03130530

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

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.

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Key information

Conditions

Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Evaluation adverse events

    Time frame: 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 outcomes

  1. Duration of hospitalisation

    Time frame: from surgery to hospital discharge, up to 30 days

    Duration of hospitalisation

  2. Duration of surgery

    Time frame: from to the start to the end of the surgery

    Duration of surgery

  3. Setup for surgery - collision rate

    Time frame: from to the start to the end of the surgery

    Registration and calculation of the collision rate

  4. Setup for surgery - reduced mobility

    Time frame: from to the start to the end of the surgery

    Registration and calculation of the reduced mobility of the tools

  5. Adverse events

    Time frame: Up to 30 days post-surgery

    Number of adverse events

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2017
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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