Clinical Trial: Surgical Treatment of Early Stage Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
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 Summary:
Sponsor: Centre Hospitalier Universitaire de Nīmes
Current Primary Outcome: The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors [ Time Frame: 1 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to prepare the surgical setting (min) [ Time Frame: 1 day ]
- Time necessary to dock the robot (min) [ Time Frame: 1 day ]
- Total surgical time (console time) (min) [ Time Frame: 1 day ]
- Intervention time taking into account cervical ganglions (min) [ Time Frame: 1 day ]
- Was a tracheotomy necessary? yes/no [ Time Frame: 1 day ]
- Presence / absence of bleeding complications [ Time Frame: 1 day ]
- Was a conversion to an open procedure necessary? yes/no [ Time Frame: 1 day ]
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire de Nīmes
Dates:
Date Received: December 9, 2010
Date Started: April 2011
Date Completion:
Last Updated: March 26, 2015
Last Verified: March 2015
