Evaluation of rehabilitation in post-laryngectomy patients
| ISRCTN | ISRCTN20496103 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20496103 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/02/2008
- Registration date
- 13/03/2008
- Last edited
- 22/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Carlos Chone
Scientific
Scientific
Faculty of Medical Sciences
University of Campinas
Tessalia Vieira de Camargo 126
13083-887
Campinas SP
6111
Brazil
| carloschone@uol.com.br |
Study information
| Study design | Criterion standard: a study of screening and diagnostic tests |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | Predictive value of oesophageal computerised manometry after total laryngectomy in patients with voice prosthesis: evaluation of pharyngo-oesophageal segment |
| Study objectives | There is a cutoff value for determination of patients with and without spasm of pharyngo-oesophageal segment under computerised manometry exam. |
| Ethics approval(s) | Ethics approval received from the Ethics in Research Committee from State University of Campinas on the 6th May 2007 (ref: 036/2007 description CAAE: 0020.0.146.000-7). |
| Health condition(s) or problem(s) studied | Cancer of larynx, voice disorders |
| Intervention | 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 voice analysis, videofluoroscopy and computerised manometry were performed 2. One group with 8 patients had spasm of pharyngo-oesophageal segment confirmed by videofluoroscopy as "gold standard", performed perceptive voice analysis, videofluoroscopy and computerised manometry, too. After they were treated with 100 units of botulinum toxin injection in the pharyngo-oesophageal segment and after one month perceptive voice analysis, videofluoroscopy and computerised manometry were repeated. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 10/03/2000 |
| Completion date | 15/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 10/03/2000 |
| Date of final enrolment | 15/09/2005 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Faculty of Medical Sciences
Campinas SP
6111
Brazil
6111
Brazil
Sponsor information
State University of Campinas (Brazil)
University/education
University/education
Disciplina de Otorrinolaringologia
Faculdade de Ciências Médicas
UNICAMP
Postal Code 6111
Cidade Universitária Zeferino Vaz
Campinas, SP
13083970
Brazil
"ROR" |
https://ror.org/04wffgt70 |
|---|
Funders
Funder type
University/education
State University of Campinas (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2011 | Yes | No |
