NCT03357107

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

November 23, 2017

Last Update Submit

November 29, 2017

Conditions

Supraglottic Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Local control

    Proportion of patients without cancer recurrence 2 years after surgery

    2 years after surgery

Interventions

Transoral robotic surgery (TORS)PROCEDURE

All patients underwent primary tumour resection with transoral robotic surgery (TORS) using the daVinci robot (Intuitive Surgical, Sunnyvale CA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, 69004, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2017

First Posted

November 29, 2017

Study Start

October 1, 2016

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

November 30, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)