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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.
 
ClinicalTrials.gov Identifier: NCT03357107
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date November 23, 2017
First Posted Date November 29, 2017
Last Update Posted Date November 30, 2017
Actual Study Start Date October 1, 2016
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 23, 2017)
Local control [ Time Frame: 2 years after surgery ]
Proportion of patients without cancer recurrence 2 years after surgery
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Local Control After Robot-assisted Supraglottic Laryngectomy
Official Title Evaluation of Local Control 2 Years After Robot-assisted Supraglottic Laryngectomy: a Multicenter Retrospective Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Supraglottic Squamous Cell Carcinoma
Intervention Procedure: Transoral robotic surgery (TORS)
All patients underwent primary tumour resection with transoral robotic surgery (TORS) using the daVinci robot (Intuitive Surgical, Sunnyvale CA)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 23, 2017)
122
Original Actual Enrollment Same as current
Actual Study Completion Date February 28, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03357107
Other Study ID Numbers CRC_GHN_2017_009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date November 2017