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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Completed
• CT.gov ID: NCT01257633
• Collaborator: (none)
• Enrollment: 54
• Locations: 3
• Duration (Months): 42
• Patients Per Site: 18
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laryngeal Neoplasms	Procedure: Transoral robot-assisted tumor resection using the da Vinci robot

Study Design

• Study Type: Observational
• Actual Enrollment: 54 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
The study population Laryngeal cancer patients requiring surgical tumor resection.	Procedure: Transoral robot-assisted tumor resection using the da Vinci robot; Transoral robot-assisted tumor resection using the da Vinci robot

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Time to prepare the surgical setting (min) [1 day]

2. Time necessary to dock the robot (min) [1 day]

3. Total surgical time (console time) (min) [1 day]

4. Intervention time taking into account cervical ganglions (min) [1 day]

5. Was a tracheotomy necessary? yes/no [1 day]

6. Presence / absence of bleeding complications [1 day]

7. Was a conversion to an open procedure necessary? yes/no [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes	Gard	France	30029
2	CHU de Montpellier - Hôpital Gui de Chauliac	Montpellier		France	34295
3	CHRU de Toulouse - Hôpital de Rangueil	Toulouse Cedex 9		France	31059

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Benjamin Lallemant, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT01257633
• Other Study ID Numbers: AOI/2010/BL-01
• First Posted: Dec 10, 2010
• Last Update Posted: Mar 27, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Centre Hospitalier Universitaire de Nīmes: da Vinci surgical robot; laryngeal cancer
• Additional relevant MeSH terms: Laryngeal Neoplasms

Study Results

No Results Posted as of Mar 27, 2015