| CTRI Number |
CTRI/2008/091/000212 [Registered on: 26/03/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A study to evaluate the damage to a nerve close to the upper part of the thyroid [external laryngeal nerve] by two different surgical techniques during thyroidetcomy operations |
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Scientific Title of Study
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Prospective single blinded -randomized study to evaluate the injury rate of the external laryngeal nerve in thyroid operations using two surgical technique. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Ben Selvan.C.K |
| Designation |
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| Affiliation |
|
| Address |
Department of Surgery, Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
91-0416-2282079 |
| Fax |
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| Email |
drckben@yahoo.com |
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Details of Contact Person
Scientific Query
|
| Name |
Ben Selvan.C.K |
| Designation |
|
| Affiliation |
|
| Address |
Department of Surgery, Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
91-0416-2282079 |
| Fax |
|
| Email |
drckben@yahoo.com |
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Details of Contact Person
Public Query
|
| Name |
Ben Selvan.C.K |
| Designation |
|
| Affiliation |
|
| Address |
Department of Surgery, Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
91-0416-2282079 |
| Fax |
|
| Email |
drckben@yahoo.com |
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
Institution |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ben Selvan.C.K |
Christian Medical College |
,-632004
Vellore
TAMIL NADU |
91-0416-228-2079
drckben@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB-Christian Medical Coolege,Vellore |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
vocal dysfunction with two surgical techniques.
To assess whether the incidence of Hypocalcaemia can be influenced by the two techniques
, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Surgical technique A |
The recurrent laryngeal nerve will be dissected first followed by the ligation of the inferior thyroid vessels, tubercle and the superior thyroid vessels, in that order. |
| Comparator Agent |
surgical technique B |
The superior thyroid vessels will be individually ligated, then the recurrent laryngeal nerve will be dissected. The inferior thyroid vessles and the Zukherhandl tubercle will be ligated. |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
at least 15 years of age
benign thyroid pathology or differentiated thyroid carcinoma
no history of professional voice training
no prior vocal pathology requiring therapy
no previous thyroid or midline neck surgery
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| ExclusionCriteria |
| Details |
Previous midline neck or thyroid surgery
Previous known operation in the larynx
known dysphonia
vocal cord paralysis
history of speech disorder
unable to sustain phonation of more than 10 seconds
hearing impairment
Locally advanced carcinoma thyroid especially when the superior pole in involved
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| a) To analyze vocal function before and after thyroidetcomy for patients with normal preoperative voice using standard multidimensional voice assessment protocol.
b) To assess whether the incidence of vocal dysfunction varies with two surgical techniques.
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10 days and 3 months following surgey |
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Secondary Outcome
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| Outcome |
TimePoints |
| To assess whether the incidence of Hypocalcaemia can be influenced by the two techniques |
On the day one of the surgery and 7th day |
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Target Sample Size
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Total Sample Size="80"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/07/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a randomized prospective single blinded two-arm study among patients scheduled to undergo primary thyroid surgery to see the influence of two standard surgical techniques in limiting the rate of external laryngeal nerve injury
Patients who meet the inclusion criteria and who give consent for the study will be included in the study. All patients with normal voice will undergo preoperative functional voice assessment which will include the physician?s or speech therapist?s appraisal of voice. Changes of pitch range, intensity fatigability will be assessed during the interview. The degree of perceptual dysphonia will be graded using the standardized voice rating scale (GRBAS). Vocal function will further be assessed by a battery of acoustic and videostroboscopic tests as part of a standardized voice assessment protocol.
Acoustic testing :
The acoustic signals will be recorded using a unidirectional microphone maintained at a mouth-to-microphone distance of 30 cm. The signals will then be analyzed using ?Ling Waves? software. The parameters studied include voice range profile, maximum phonation time, fundamental frequency, jitter, shimmer and harmonics-to-noise ratio.
Vocal fold imaging :
Videostroboscopy will be performed with Storz videostroboscope. The images will be stored on a computer and subsequently evaluated to assess the symmetry of vocal fold vibration, amplitude and regularity of vocal fold movement and mucosal wave characteristics.
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