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

NCT ID: NCT03130530

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-01

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Colorectal Surgery

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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ALF-X

all patient underwent robotic colorectal surgery using ALF-X system

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonino Spinelli, Prof.

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Other Identifiers

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RETROSPECTIVE-2016

Identifier Type: -

Identifier Source: org_study_id

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