| CTRI Number |
CTRI/2018/12/016652 [Registered on: 13/12/2018] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study about deficiency of thyroid hormones following removal of larynx in laryngeal cancers |
|
Scientific Title of Study
|
An Observational study on the incidence of hypothyroidism and hypoparathyroidism in patients undergoing total laryngectomy or laryngopharyngectomy with hemithyroidectomy with or without post operative radiation therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Architha Menon P |
| Designation |
Junior Resident , MS ENT |
| Affiliation |
Kasturba Medical college , Manipal |
| Address |
Department of ENT , Kasturba Medical College, Manipal , Madhava nagar , manipal, udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9538417393 |
| Fax |
|
| Email |
archz5691@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BALAKRISHNAN R |
| Designation |
PROFESSOR AND HEAD OF UNIT |
| Affiliation |
Kasturba Medical college , Manipal |
| Address |
Department of ENT , Kasturba Medical College, Manipal , Madhava nagar , manipal, udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9845383714 |
| Fax |
|
| Email |
baluent@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Architha Menon P |
| Designation |
Junior Resident , MS ENT |
| Affiliation |
Kasturba Medical college , Manipal |
| Address |
Department of ENT , Kasturba Medical College, Manipal , Madhava nagar , manipal, udupi
KARNATAKA
576104
India |
| Phone |
9538417393 |
| Fax |
|
| Email |
archz5691@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical college Manipal |
|
|
Primary Sponsor
|
| Name |
DR Architha Menon P |
| Address |
Dept Of ENT , Kasturba Medical College Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [PRINCIPAL INVESTIGATOR] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ARCHITHA MENON P |
Kasturba Medical college Manipal |
Department of ENT,Fourth floor, Kasturba Medical college Manipal , Madhava nagar,Manipal,Udupi
Udupi
KARNATAKA |
9538417393
archz5691@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MANIPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary cancer of larynx and hypopharynx undergoing total laryngectomy/laryngopharyngectomy with hemithyroidectomy
Patients undergoing radiotherapy post laryngectomy
|
|
| ExclusionCriteria |
| Details |
Patients with preoperative thyroid disease.
Patients with second primary or those who received radiotherapy prior to surgery for any cause.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of hypothyroidism and hypoparthyroidism |
Before surgery
1 week post surgery
6weeks post surgery
4weeks post radiation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Helps to assess subclinical and clinical hypothyroidism and hypoparathyroidism and treatment can be commenced as early as possible. Hence improves the lifestyle and general well being of the patient |
Before surgery
1 week post surgery
6weeks post surgery
4weeks post radiation |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/12/2018 |
| Date of Study Completion (India) |
05/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/06/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is to determine the incidence of hypothyroidism or
hypoparathyroidism in patients diagnosed with laryngeal and hypopharyngeal
malignancies undergoing total
laryngectomy or laryngopharyngectomy
with hemithyroidectomy with or without post operative radiation therapy . Helps to assess subclinical and clinical
hypothyroidism and hypoparathyroidism and treatment can be commenced as early
as possible. Hence improves the lifestyle and general well being of the patient. |