Local Control After Robot-assisted Supraglottic Laryngectomy

Supraglottic Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357107
• Other study ID #: CRC_GHN_2017_009
• Status: Completed
• Phase: N/A
• First received: November 23, 2017
• Last updated: November 29, 2017
• Start date: October 1, 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: November 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• 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)

Locations

Country	Name	City	State
France	Croix-Rousse Hospital, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control	Proportion of patients without cancer recurrence 2 years after surgery	2 years after surgery