Condition category
Respiratory
Date applied
27/02/2013
Date assigned
27/03/2013
Last edited
06/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23974970

Publication citations

  1. 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.

Additional files

Editorial Notes