Establishment of an Artificial Larynx After Total Laryngectomy

Not Applicable

• Conditions: Carcinomatous Disease

• Registration Number: NCT01474005
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-20
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy

Exclusion Criteria

• Less than 18 years
• Contraindications to general anesthesia
• Any situation considered by the physician operator as an exclusion
• Pregnant women
• Lactating women
• Subglottic or basi-lingual tumor extension more than 1 cm
• Prior radiotherapy
• Severe coagulation disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of the restoration of respiratory functions	one year	4 items will be used: * 0: no dyspnea; * 1: moderate dyspnea; * 2: significant dyspnea; * 3: major dyspnea
Evaluation of the restoration of the ability to swallow by nasofibroscopy	one year	3 items will be used: * 1: no aspiration; * 2: moderate aspiration; * 3: massive aspiration

Trial Locations

Locations (1)

Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière; 🇫🇷 Strasbourg, France