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

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091546
Enrollment
64
Registered
2025-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E079- Disorder of thyroid, unspecified

Interventions

Intervention1: Trans-oral vestibular Robotic thyroidectomy (TORT): Thyroidectomy will be done through vesticular route with help of robotic assistance Control Intervention1: Bilateral-axillo-breast Ap

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Benign or cytologically indeterminate lesions involving single lobe of size less than 4cm or 40ml.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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. Timepoint: baseline 10 days 3 months postsurgery

Countries

India

Contacts

Public ContactDr Anjali Khatri

AIIMS New Delhi

dranitadharbhan@gmail.com9810198239

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026