Evaluation of rehabilitation in post-laryngectomy patients

ISRCTN	ISRCTN20496103
DOI	https://doi.org/10.1186/ISRCTN20496103
Protocol serial number	N/A
Sponsor	State University of Campinas (Brazil)
Funder	State University of Campinas (Brazil)

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

Faculty of Medical Sciences
University of Campinas
Tessalia Vieira de Camargo 126
13083-887
Campinas SP
6111
Brazil

Email	carloschone@uol.com.br

Study information

Primary study design	Interventional
Study design	Criterion standard: a study of screening and diagnostic tests
Secondary study design	Non randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	15/09/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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