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

Completed

• Conditions: Laryngeal Neoplasms
• Interventions: Procedure: Transoral robot-assisted tumor resection using the da Vinci robot

• Registration Number: NCT01257633
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Study Start: 2011-04
• Primary Completion: 2013-12
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	Transoral robot-assisted tumor resection using the da Vinci robot	Laryngeal cancer patients requiring surgical tumor resection.

Primary Outcome Measures

Name	Time	Method
The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors	1 day

Secondary Outcome Measures

Name	Time	Method
Time to prepare the surgical setting (min)	1 day
Time necessary to dock the robot (min)	1 day
Total surgical time (console time) (min)	1 day
Intervention time taking into account cervical ganglions (min)	1 day
Was a tracheotomy necessary? yes/no	1 day
Presence / absence of bleeding complications	1 day
Was a conversion to an open procedure necessary? yes/no	1 day

Trial Locations

Locations (3)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes, Gard, France

CHRU de Toulouse - Hôpital de Rangueil; 🇫🇷 Toulouse Cedex 9, France

CHU de Montpellier - Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France