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Comparison between laser and diathermy assisted posterior cordotomy for bilateral vocal cord abductor paralysis
ISRCTN ISRCTN08093874
DOI 10.1186/ISRCTN08093874
ClinicalTrials.gov identifier
EudraCT number
Public title Comparison between laser and diathermy assisted posterior cordotomy for bilateral vocal cord abductor paralysis
Scientific title Comparison between laser and diathermy assisted posterior cordotomy for bilateral vocal cord abductor paralysis: a prospective randomized controlled trial
Acronym N/A
Serial number at source N/A
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.
Lay 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
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
Countries of recruitment Egypt
Disease/condition/study domain Optimum method of cordotomy
Participants - 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.
Participants - 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.
Anticipated start date 01/02/2008
Anticipated end date 01/02/2011
Status of trial Completed
Patient information material 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
Target number of participants 20
Interventions 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.
Primary outcome measure(s) 1. Dyspnea severity scale
2. Voice assessment protocol
3. Pearson aspiration scale
Secondary outcome measure(s) No secondary outcome measures
Sources of funding Zagazig University (Egypt) - Otorhinolaryngology, Head and Neck Surgery Department
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23974970
Contact name Dr  Mohammad  El-Anwar
  Address Otorhinolaryngology, Head and Neck Surgery Department
Faculty of Medicine
Zagazig University
  City/town Zagazig
  Zip/Postcode 44519
  Country Egypt
  Tel +20 552309843
  Email mwenteg@yahoo.com
Sponsor Zagazig University (Egypt)
  Address c/o Mohammad Waheed El-Anwar
Otorhinolaryngology, Head and Neck Surgery Department
Faculty of Medicine
  City/town Zagazig
  Zip/Postcode -
  Country Egypt
  Tel +20 1004695197
  Email deanofficezu@gmail.com
Date applied 27/02/2013
Last edited 06/01/2014
Date ISRCTN assigned 27/03/2013
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