CTRI

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CTRI Number

CTRI/2025/07/091546 [Registered on: 23/07/2025] Trial Registered Prospectively

Last Modified On:

23/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison between method of thyroidectomy operation done with incision away from neck over chest and from mouth, with help of robot.

Scientific Title of Study

Comparison of Patient Reported Outcome Measures(PROM)in Trans-oral Robotic Thyroidectomy(TORT) and Bilateral Axillo-Breast Approach Robotic Thyroidectomy (BABA-RT) for benign and intermediate thyroid lesions- A Randomized Control Trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Anita
Designation	Professor
Affiliation	AIIMS New Delhi
Address	Ansari Nagar New Delhi DELHI 110029 India
Phone	9810198239
Fax
Email	dranitadharbhan@gmail.com

Details of Contact Person
Scientific Query

Name	Anita
Designation	Professor
Affiliation	AIIMS New Delhi
Address	Ansari Nagar New Delhi DELHI 110029 India
Phone	9810198239
Fax
Email	dranitadharbhan@gmail.com

Details of Contact Person
Public Query

Name	Dr Anjali Khatri
Designation	M.S. trainee
Affiliation	AIIMS New Delhi
Address	Ansari Nagar New Delhi DELHI 110029 India
Phone	8758214311
Fax
Email	akhatri997@gmail.com

Source of Monetary or Material Support

none

Primary Sponsor

Name	AIIMS New Delhi
Address	Ansari nagar, New Delhi , 110029
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Anita	AIIMS New Delhi	Ansari Nagar New Delhi DELHI	9810198239 dranitadharbhan@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E079\|\|Disorder of thyroid, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Bilateral-axillo-breast Approach robotic thyroidectomy(BABA-RT)	Thyroidectomy will be done through bilateral Breast and axillary route with help of robotic assistance
Intervention	Trans-oral vestibular Robotic thyroidectomy (TORT)	Thyroidectomy will be done through vesticular route with help of robotic assistance

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1.Benign or cytologically indeterminate lesions involving single lobe of size less than 4cm or 40ml.

ExclusionCriteria

Details

1.Refusal to give consent
2.Patients not fit for general anaesthesia/ neck extension required for surgical positioning
3.History of head and neck surgery and previous irradiation
4.All thyroid lesions of size more than 4 cm or 40ml
•All malignant lesions of thyroid
•Evidence of active clinical hyperthyroidism or thyroiditis
•Substernal thyroidal extension of swelling

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1.To compare the Patient Reported Outcome Measures (PROM) in surgeries, TORT vs BABA- RT for benign and indeterminate thyroid swellings	After surgery

Secondary Outcome

Outcome

TimePoints

1.To study for safety to compare the outcomes of TORT & BABART in terms of recurrent laryngeal nerve injury, parathyroid injury, blood loss, pain, respiratory distress, subcutaneous ecchymosis & paresthesia over neck, chin & chest.
2.To compare the TORT with BABA RT in terms of operating time
3.To compare the TORT with BABA RT in terms of the ease of doing the procedure by the surgeon on a Likert scale of 1 to 5.
4.To compare the TORT with BABA RT in terms of inflammatory response of body to both procedures.

baseline 10 days 3 months postsurgery

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)

10/08/2025

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="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

Traditional open thyroidectomy often results in visible neck scars and increased postoperative discomfort. Endoscopic approaches improve cosmesis but are limited by instrument mobility. Robotic techniques overcome these limitations with enhanced precision, 3D vision, and better ergonomics. By comparing two scarless robotic techniques, this study aims to identify which approach offers superior outcomes in terms of pain, cosmesis, voice, and quality of life. The findings will guide surgeons in selecting optimal techniques and support patient-centered, minimally invasive thyroid surgery practices based on robust clinical evidence. This study will help in determining which robotic approach is better for patients to have a good quality of life postoperatively. This study will help in defining the procedure which causses less cpmplications and more ease of doing.