Surgical Treatment of Early Stage Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance

Laryngeal Neoplasms Clinical Trial

Official title:

Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257633
• Other study ID #: AOI/2010/BL-01
• Status: Completed
• Phase: N/A
• First received: December 9, 2010
• Last updated: March 26, 2015
• Start date: April 2011
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• The subject has signed consent

• The subject must be a member or beneficiary of a health insurance plan

• The patient is available for 12 months of follow-up

• The subject has a cancer of the larynx:

• classified T1 or T2 in the TNM

• glottic localization and / or supraglottic regardless of node status

• with or without a history of head and neck cancer

• The subject does not have distant metastasis (M0)

• A decision for endoscopic robot-assisted surgery is retained in multidisciplinary meeting

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Laryngeal Neoplasms

Intervention

Procedure:
• Transoral robot-assisted tumor resection using the da Vinci robot
Transoral robot-assisted tumor resection using the da Vinci robot

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Gui de Chauliac	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes	Gard
France	CHRU de Toulouse - Hôpital de Rangueil	Toulouse Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors		1 day	No
Secondary	Time to prepare the surgical setting (min)		1 day	No
Secondary	Time necessary to dock the robot (min)		1 day	No
Secondary	Total surgical time (console time) (min)		1 day	No
Secondary	Intervention time taking into account cervical ganglions (min)		1 day	No
Secondary	Was a tracheotomy necessary? yes/no		1 day	No
Secondary	Presence / absence of bleeding complications		1 day	Yes
Secondary	Was a conversion to an open procedure necessary? yes/no		1 day	No