Local Control After Robot-assisted Supraglottic Laryngectomy

November 29, 2017 updated by: Hospices Civils de Lyon

Evaluation of Local Control 2 Years After Robot-assisted Supraglottic Laryngectomy: a Multicenter Retrospective Study

Transoral robotic surgery is an option to treat supraglottic squamous cell carcinomas. Oncological outcomes 2 years after transoral robotic surgery for supraglottic laryngectomy were studied.

Study Overview

Status

Completed

Conditions

Supraglottic Squamous Cell Carcinoma

Intervention / Treatment

Procedure: Transoral robotic surgery (TORS)

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Lyon, France, 69004
    - Croix-Rousse Hospital, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with supraglottic squamous cell carcinoma who had undergone robot-assisted supraglottic laryngectomy and with at least 2 years follow-up

Description

Inclusion Criteria:

Men or women over 18 years of age
Patients with supra-glottic squamous cell carcinoma from T1 to T3, all stages N
Patients with a robot assisted supra-glottic laryngectomy with at least 2 years follow-up

Exclusion Criteria:

Patients for whom follow-up of at least 2 years has not been achieved;
Major patients protected by the law (under guardianship or guardianship);
Patients who expressed opposition to their participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control Time Frame: 2 years after surgery	Proportion of patients without cancer recurrence 2 years after surgery	2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

February 28, 2017

Study Completion (ACTUAL)

February 28, 2017

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria