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Completed

NCT Number: NCT01257633

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

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.

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Key information

Conditions

Laryngeal Neoplasms Head and Neck Neoplasms Laryngeal Diseases Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau, Nîmes, Gard, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Transoral robot-assisted tumor resection using the da Vinci robot

Procedure

Transoral robot-assisted tumor resection using the da Vinci robot

Primary outcomes

  1. The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors

    Time frame: 1 day

Secondary outcomes

  1. Time to prepare the surgical setting (min)

    Time frame: 1 day

  2. Time necessary to dock the robot (min)

    Time frame: 1 day

  3. Total surgical time (console time) (min)

    Time frame: 1 day

  4. Intervention time taking into account cervical ganglions (min)

    Time frame: 1 day

  5. Was a tracheotomy necessary? yes/no

    Time frame: 1 day

  6. Presence / absence of bleeding complications

    Time frame: 1 day

  7. Was a conversion to an open procedure necessary? yes/no

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2010
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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