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Local Control After Robot-assisted Supraglottic Laryngectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03357107
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : November 30, 2017
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Supraglottic Squamous Cell Carcinoma Procedure: Transoral robotic surgery (TORS)

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Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Local Control 2 Years After Robot-assisted Supraglottic Laryngectomy: a Multicenter Retrospective Study
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Intervention Details:
  • Procedure: Transoral robotic surgery (TORS)
    All patients underwent primary tumour resection with transoral robotic surgery (TORS) using the daVinci robot (Intuitive Surgical, Sunnyvale CA)

Primary Outcome Measures :
  1. Local control [ Time Frame: 2 years after surgery ]
    Proportion of patients without cancer recurrence 2 years after surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03357107

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Croix-Rousse Hospital, Hospices Civils de Lyon
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon Identifier: NCT03357107    
Other Study ID Numbers: CRC_GHN_2017_009
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell