Comparison between laser and diathermy assisted posterior cordotomy for bilateral vocal cord abductor paralysis

ISRCTN ISRCTN08093874
DOI https://doi.org/10.1186/ISRCTN08093874
Secondary identifying numbers N/A
Submission date
27/02/2013
Registration date
27/03/2013
Last edited
06/01/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Mohammad El-Anwar
Scientific

Otorhinolaryngology, Head and Neck Surgery Department
Faculty of Medicine
Zagazig University
Zagazig
44519
Egypt

Phone +20 552309843
Email mwenteg@yahoo.com

Study information

Study designProspective randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant 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
Scientific titleComparison between laser and diathermy assisted posterior cordotomy for bilateral vocal cord abductor paralysis: a prospective randomized controlled trial
Study objectivesIt 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(s)Zagazig University Ethical Committee had approved this study and written formal consents had been signed by patients or their relatives
Health condition(s) or problem(s) studiedOptimum method of cordotomy
InterventionParticipants 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 typeOther
Primary outcome measure1. Dyspnea severity scale
2. Voice assessment protocol
3. Pearson aspiration scale
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/02/2008
Completion date01/02/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteriaPatients [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.
Key exclusion criteria1. 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.
Date of first enrolment01/02/2008
Date of final enrolment01/02/2011

Locations

Countries of recruitment

  • Egypt

Study participating centre

Otorhinolaryngology, Head and Neck Surgery Department
Zagazig
44519
Egypt

Sponsor information

Zagazig University (Egypt)
University/education

c/o Mohammad Waheed El-Anwar
Otorhinolaryngology, Head and Neck Surgery Department
Faculty of Medicine
Zagazig
-
Egypt

Phone +20 1004695197
Email deanofficezu@gmail.com
ROR logo "ROR" https://ror.org/053g6we49

Funders

Funder type

University/education

Zagazig University (Egypt) - Otorhinolaryngology, Head and Neck Surgery Department

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2013 Yes No