Plain English Summary
Background and study aims
Bilateral vocal cord paralysis (BVCP) is a potentially life threatening condition frequently requires surgical intervention called cordotomy. The objectives of treatment of BVCP are to achieve adequate airway and to preserve voice quality and laryngeal competence. The study compares two types of cordotomy.
Who can participate?
All patients with BVCP for one year at least with a respiratory chink of a maximal width of 4 mm or less and who need cordotomy.
What does the study involve?
Over a period of three years participants will be randomly allocated to one of two groups; Group (A) will be treated with laser assisted posterior cordotomy and Group (B) will be treated with diathermy assisted posterior cordotomy. The choice of the group will be decided by a process called randomisation, which is like a coin toss. During and at the end of the study, dyspnea severity, voice quality and aspiration will be assessed and compared between both groups.
What are the possible benefits and risks of participating?
There will be mostly improvement of the airway. But there will be benefits to future best methods of treating BVCP.
The main risk of cordotomy is laryngeal edema, decrease quality of voice or aspiration. All patients will receive routine care, safety procedures to monitor airway and follow up for cordotomy.
Where is the study run from?
This study was performed in Zagazig University Hospitals (Egypt).
When is study starting and how long is it expected to run for?
The study lasted from February 2008 to February 2011 on 20 patients. Participants were for a period of two to three years.
Who is funding the study?
Zagazig University Hospitals (Egypt)
Who is the main contact?
Dr Mohammad Waheed El-Anwar
mwenteg@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mohammad El-Anwar
ORCID ID
Contact details
Otorhinolaryngology
Head and Neck Surgery Department
Faculty of Medicine
Zagazig University
Zagazig
44519
Egypt
+20 552309843
mwenteg@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison between laser and diathermy assisted posterior cordotomy for bilateral vocal cord abductor paralysis: a prospective randomized controlled trial
Acronym
Study hypothesis
It is hypothesised that the results of laser assisted posterior cordotomy will be better than diathermy assisted posterior cordotomy for bilateral vocal cord paralysis (BVCP) in regard to dyspnea severity, voice quality and aspiration.
Ethics approval
Zagazig University Ethical Committee had approved this study and written formal consents had been signed by patients or their relatives
Study design
Prospective randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Dr. Mohammad Waheed El-Anwar
Address: Otorhinolaryngology, Head and Neck Surgery Department, Faculty of Medicine, Zagazig University, Egypt. Tel: 00201004695197
Email: mwenteg@yahoo.com
Condition
Optimum method of cordotomy
Intervention
Participants will be randomly categorized into two groups:
Group (A) will be treated with laser assisted posterior cordotomy
Group (B) will be treated with diathermy assisted posterior cordotomy
During and at the end of the study, dyspnea severity, voice quality and aspiration will be assessed and compared between both groups.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Dyspnea severity scale
2. Voice assessment protocol
3. Pearson aspiration scale
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/02/2008
Overall trial end date
01/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients [male and female, any age (no age limitation)] who are diagnosed as having bilateral abductor vocal cord paralysis for one year at least and maximal width of respiratory chink is 4 mm or less.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Patients have unilateral vocal cord paralysis.
2. Patients who are diagnosed as having bilateral abductor vocal cord paralysis for lee than one year duration.
3. Maximal width of respiratory chink is more than 4 mm.
Recruitment start date
01/02/2008
Recruitment end date
01/02/2011
Locations
Countries of recruitment
Egypt
Trial participating centre
Otorhinolaryngology, Head and Neck Surgery Department
Zagazig
44519
Egypt
Sponsor information
Organisation
Zagazig University (Egypt)
Sponsor details
c/o Mohammad Waheed El-Anwar
Otorhinolaryngology
Head and Neck Surgery Department
Faculty of Medicine
Zagazig
-
Egypt
+20 1004695197
deanofficezu@gmail.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Zagazig University (Egypt) - Otorhinolaryngology, Head and Neck Surgery Department
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23974970
Publication citations
-
Results
Mohamed NN, Sorour SS, El-Anwar MW, Quriba AS, Mahdy MA, Comparison between laser- and diathermy-assisted posterior cordotomy for bilateral vocal cord abductor paralysis., JAMA Otolaryngol Head Neck Surg, 2013, 139, 9, 923-930, doi: 10.1001/jamaoto.2013.3554.