Condition category
Cancer
Date applied
19/02/2008
Date assigned
13/03/2008
Last edited
22/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

State University of Campinas (Brazil)

Sponsor details

Disciplina de Otorrinolaringologia
Faculdade de Ciências Médicas
UNICAMP
Postal Code 6111
Cidade Universitária “Zeferino Vaz”
Campinas
SP
13083970
Brazil

Sponsor type

University/education

Website

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

  1. 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.

Additional files

Editorial Notes