Contact information
Type
Scientific
Primary contact
Prof Carlos Chone
ORCID ID
Contact details
Faculty of Medical Sciences
University of Campinas
Tessalia Vieira de Camargo 126
13083-887
Campinas SP
6111
Brazil
carloschone@uol.com.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Predictive value of oesophageal computerised manometry after total laryngectomy in patients with voice prosthesis: evaluation of pharyngo-oesophageal segment
Acronym
Study hypothesis
There is a cutoff value for determination of patients with and without spasm of pharyngo-oesophageal segment under computerised manometry exam.
Ethics approval
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).
Study design
Criterion standard: a study of screening and diagnostic tests
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
10/03/2000
Overall trial end date
15/09/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
10/03/2000
Recruitment end date
15/09/2005
Locations
Countries of recruitment
Brazil
Trial participating centre
Faculty of Medical Sciences
Campinas SP
6111
Brazil
Funders
Funder type
University/education
Funder name
State University of Campinas (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21838094
Publication citations
-
Results
Chone CT, Spina AL, Barcellos IH, Servin HH, Crespo AN, A prospective study of long-term dysphagia following total laryngectomy., B-ENT, 2011, 7, 2, 103-109.