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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01257633
Enrollment
54
Registered
2010-12-10
Start date
2011-04-30
Completion date
2014-09-30
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Neoplasms

Keywords

da Vinci surgical robot, laryngeal cancer

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.

Interventions

PROCEDURETransoral robot-assisted tumor resection using the da Vinci robot

Transoral robot-assisted tumor resection using the da Vinci robot

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frame
The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors1 day

Secondary

MeasureTime frame
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
Time to prepare the surgical setting (min)1 day
Presence / absence of bleeding complications1 day
Was a conversion to an open procedure necessary? yes/no1 day
Was a tracheotomy necessary? yes/no1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026