| CTRI Number |
CTRI/2024/10/076056 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomised Controlled study of change in voice between flapless and conventional total thyroidectomy |
|
Scientific Title of Study
|
COMPARISON OF VOICE CHANGE BETWEEN FLAPLESS AND CONVENTIONAL TOTAL THYROIDECTOMY – A RANDOMISED CONTROLLED STUDY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANICKA AAKASH |
| Designation |
PG student |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF SURGERY,
2nd floor,DR BL TANEJA BLOCK
LOK NAYAK HOSPITAL AND MAMC,
JAWAHARLAL NEHRU MARG
NEAR DELHI GATE
NEW DELHI
New Delhi
DELHI
110002
India |
| Phone |
9597538854 |
| Fax |
|
| Email |
maniash490@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. CHANDRA BHUSHAN SINGH |
| Designation |
Consultant |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF SURGERY,
DR BL TANEJA BLOCK,
LOK NAYAK HOSPITAL & MAMC,
JAWAHARLAL NEHRU MARG,
NEAR DELHI GATE,
NEW DELHI.
New Delhi
DELHI
110002
India |
| Phone |
9597538854 |
| Fax |
|
| Email |
drchandrabhushansingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANICKA AAKASH |
| Designation |
PG student |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF SURGERY,
2nd floor, DR BL TANEJA BLOCK,
LOK NAYAK HOSPITAL AND MAMC,
JAWAHARLAL NEHRU MARG
NEAR DELHI GATE
NEW DELHI
New Delhi
DELHI
110002
India |
| Phone |
9597538854 |
| Fax |
|
| Email |
maniash490@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAULANA AZAD MEDICAL COLLEGE,
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi,India - 110002
|
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi,India - 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 MANICKA AAKASH |
MAULANA AZAD MEDICAL COLLEGE and LOK NAYAK HOSPITAL |
DEPARTMENT OF SURGERY,
DR BL TANEJA BLOCK,
LOK NAYAK HOSPITAL AND MAMC,
NEW DELHI,INDIA- 110002.
New Delhi
DELHI |
9597538854
maniash490@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E042||Nontoxic multinodular goiter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL TOTAL THYROIDECTOMY |
COMPARISON OF VOICE CHANGE BETWEEN FLAPLESS AND CONVENTIONAL TOTAL THYROIDECTOMY 2 weeks and 1month after surgery |
| Intervention |
FLAPLESS TOTAL THYROIDECTOMY |
COMPARISON OF VOICE CHANGE BETWEEN FLAPLESS AND CONVENTIONAL TOTAL THYROIDECTOMY 2 weeks and 1 month after surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years |
|
| ExclusionCriteria |
| Details |
1.Individuals with past history of neck surgery
2.Established voice disorders
3.Alteration in vocal cord movements on pre-operative indirect laryngoscopy
4.History of irradiation to head and neck in the past
5.Locally invasive thyroid malignancy
6.Lymph nodes dissection along with total thyroidectomy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of change in voice between 2 groups |
2 weeks and 1 month after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative hypocalcemia |
1st day & 7th day of surgery |
| Occurrence of postoperative seroma |
1st day & 7th day of surgery |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will show that between flapless and conventional total thyroidectomy , which has less incidence of change in voice and also associated lesser complications. |