Evaluation of rehabilitation in post-laryngectomy patients

Completed

• Conditions: Cancer of larynx, voice disorders; Cancer; Cancer of larynx

• Registration Number: ISRCTN20496103
• Lead Sponsor: State University of Campinas (Brazil)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Submitted to total laryngectomy
2. Rehabilitated with voice prosthesis
3. With tracheoesophageal voice
4. With and without spasm
5. Diagnosed with videofluoroscopy under phonation and deglutition
6. Adults of either sex

All patients submitted to perceptive voice analysis, videofluoroscopy under phonation and deglutition and computerised manometry. Patients treated with botulinum toxin injection in pharyngo-oesophageal segment were submitted to all examinations before and after treatment.

Exclusion Criteria

1. Not submitted to total laryngectomy
2. Without voice prosthesis
3. Without any of the exams:
3.1. Perceptive voice analysis
3.2. Videofluoroscopy under phonation
3.3. Deglutition
3.4. Computerised manometry
4. Those submitted to treatment of spasm, when any of these exams were not performed before and after treatment:
4.1. Perceptive voice analysis
4.2. Videofluoroscopy under phonation
4.3. Deglutition
4.4. Computerised manometry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of a cutoff value for diagnosis of spasm of pharyngo-oesophageal segment (PES) with computerised manometry (CM) or PES in total laryngectomy (TL) patients. <br><br>In the group without spasms, outcomes were measured after selection criteria were established. In the group with spasms, after the requirements of selection criteria were fulfilled, the patients were selected and all measurements were done. Then treatment with botulinum toxin was done and after one month of application of toxin all measurements were repeated.

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of degree of statistical difference of mean values of computerised manometry between patients with and without spasm<br>2. Evaluation of improvement of fluency of speech in patients with spasm after application of botulinum toxin in pharyngo-oesophageal segment<br><br>In the group without spasms, outcomes were measured after selection criteria were established. In the group with spasms, after the requirements of selection criteria were fulfilled, the patients were selected and all measurements were done. Then treatment with botulinum toxin was done and after one month of application of toxin all measurements were repeated.