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
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
Scientific
Otorhinolaryngology, Head and Neck Surgery Department
Faculty of Medicine
Zagazig University
Zagazig
44519
Egypt
| Phone | +20 552309843 |
|---|---|
| mwenteg@yahoo.com |
Study information
| Study design | Prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 title | Comparison between laser and diathermy assisted posterior cordotomy for bilateral vocal cord abductor paralysis: a prospective randomized controlled trial |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 1. Dyspnea severity scale 2. Voice assessment protocol 3. Pearson aspiration scale |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/02/2008 |
| Completion date | 01/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/02/2008 |
| Date of final enrolment | 01/02/2011 |
Locations
Countries of recruitment
- Egypt
Study participating centre
44519
Egypt
Sponsor information
University/education
c/o Mohammad Waheed El-Anwar
Otorhinolaryngology, Head and Neck Surgery Department
Faculty of Medicine
Zagazig
-
Egypt
| Phone | +20 1004695197 |
|---|---|
| deanofficezu@gmail.com | |
"ROR" |
https://ror.org/053g6we49 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/09/2013 | Yes | No |
