| CTRI Number |
CTRI/2025/03/083649 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to understand the recovery of any loss of sensation of chest wall following endoscopic thyroid surgery |
|
Scientific Title of Study
|
A Prospective Observational Study on Sensory Changes, Analyzing Paresthesia/Hypoesthesia in the Neck and Anterior Chest Following Endoscopic Thyroidectomy via Axillo Breast and Bilateral Axillo Breast Approaches done for Benign or Cytologically Indeterminate lesion |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anita Dhar |
| Designation |
professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no 430
Fourth Floor
Department of Surgical Disciplines
Surgery Block
South
DELHI
110029
India |
| Phone |
09810198239 |
| Fax |
|
| Email |
dranitadharbhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Dhar |
| Designation |
professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no 430
Fourth Floor
Department of Surgical Disciplines
Surgery Block
DELHI
110029
India |
| Phone |
09810198239 |
| Fax |
|
| Email |
dranitadharbhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkatesh S |
| Designation |
Tranee M.S. |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no 430
Fourth Floor
Department of Surgical Disciplines
Surgery Block
South
DELHI
110029
India |
| Phone |
08939273303 |
| Fax |
|
| Email |
venkatesh591999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room 430, 4th Floor, Surgery Block, Department of Surgical Disciplines, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| Type of Sponsor |
Other [] |
|
|
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 Anita Dhar |
All India Institute of Medical Sciences New Delhi |
Room 430, 4th Floor, Surgery Block, Department of Surgical Disciplines, AIIMS, New Delhi
South
DELHI |
9810198239
dranitadharbhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E079||Disorder of thyroid, unspecified, (2) ICD-10 Condition: E078||Other specified disorders of thyroid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endoscopic Thyroidectomy Surgery |
Thyroid Surgery will be done using endoscope/ laparoscope by making access through small incisions at Axilla and periareolar site bilaterally - BABA approach. Intervention in the form of surgery is one time but followed up at one, 7, 30 and 90 days after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years
Benign or cytologically indeterminate lesions involving single lobe of size 6cm or 60cm or both lobes
|
|
| ExclusionCriteria |
| Details |
Age below 18 yrs
Refusal to give consent
Patients not fit for general anaesthesia/neck
extension required for surgical positioning
History of head and neck surgery and previous irradiation
1 All thyroid lesions of size 6 cm or 60ml
2 All malignant lesions of thyroid
3 Evidence of active clinical hyperthyroidism or thyroiditis
4 Substernal thyroidal extension of swelling
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence and resolution of neck and anterior chest paresthesia/hypoesthesia in patients undergoing endoscopic thyroidectomy via Axillo-breast and Bilateral Axillo-breast approaches done for Benign or Cytologically Indeterminate Lesions |
preoperatively, postoperatively on day 1, 3, 7, 30, 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of paresthesia/hypoesthesia in the neck & anterior chest wall & also other associated complications following endoscopic thyroidectomy via Axillo-breast & Bilateral Axillo-breast approaches done for Benign or Cytologically Indeterminate Lesions in terms of quality of life. |
baseline before surgery
at Post operative 1 day 10 days 30 days 90 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="6"
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
|
Endoscopic Thyroidectomy has been a revolutionary invention in the evolution of thyroid surgeries. However, defining its commonly encountered complications and its impact on the quality of life, as it becomes prudent for both the patient and the surgeon so that they are made well aware of the impact of such complications in the postoperative period.Endoscopic Thyroidectomy has been a revolutionary invention in the evolution of thyroid surgeries. However, defining its commonly encountered complications and its impact on the quality of life, as it becomes prudent for both the patient and the surgeon so that they are made well aware of the impact of such complications in the postoperative period. |