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Evaluation of rehabilitation in post-laryngectomy patients

Predictive value of oesophageal computerised manometry after total laryngectomy in patients with voice prosthesis: evaluation of pharyngo-oesophageal segment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20496103
Enrollment
20
Registered
2008-03-13
Start date
2000-03-10
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of larynx, voice disorders Cancer Cancer of larynx

Interventions

Follow-up ranged from two to seven years: 1. One group with 12 patients were without spasm, confirmed by videofluoroscopy as "gold standard" of pharyngo-oesophageal segment and the tests perceptive vo

Sponsors

State University of Campinas (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. 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

MeasureTime frame
1. Evaluation of degree of statistical difference of mean values of computerised manometry between patients with and without spasm 2. Evaluation of improvement of fluency of speech in patients with spasm after application of botulinum toxin in pharyngo-oesophageal segment 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.

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026