Removal of thyroid swelling without any scar on the neck in non cancerous thyroid disease

â??A randomized controlled trial to compare the safety and outcome of trans-oral vestibular and axillo-breast approach for endoscopic hemithyroidectomy in patients with benign thyroid swellingsâ??

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/11/016462

Enrollment

136

Registered

2018-11-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: E078- Other specified disorders of thyroid

Interventions

Intervention1: Arm B: Patients with unilateral benign thyroid lesions of â?¤ 5cm or 40ml with no evidence of substernal extension undergoing endoscopic hemithyroidectomy via axillo-breast approach. In

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age above 18 years 2)Benign or cytologically indeterminate lesions involving single lobe of size

Exclusion criteria

Exclusion criteria: 1)Age below 18 yrs 2)Refusal to give consent 3)Patients not fit for general anaesthesia/ neck extension required for surgical positioning 4)History of head and neck surgery and previous irradiation 5) All thyroid lesions of size Ë? 5 cm or 40ml 6) All thyroid lesions involving both lobes of thyroid requiring total thyroidectomy 7) All malignant lesions of thyroid 8) Evidence of active clinical hyperthyroidism or thyroiditis 9) Substernal thyroidal extension of swelling

Design outcomes

Primary

Measure	Time frame
To compare the safety of trans-oral vestibular Vs axillo-breast approach in terms of complications. â?¢To compare the feasibility of trans-oral vestibular Vs axillo-breast approach in terms of conversion to open. â?¢To compare the outcome of trans-oral vestibular Vs axillo-breast approach in terms of patient satisfaction (cosmesis and postoperative neck discomfort or pain) on a Likert scale of 1 to 5. Timepoint: BEFORE SURGERY AND DAY 1, 10 AND 90 POST SURGERY	—

Measure

Time frame

To compare the safety of trans-oral vestibular Vs axillo-breast approach in terms of complications. â?¢To compare the feasibility of trans-oral vestibular Vs axillo-breast approach in terms of conversion to open. â?¢To compare the outcome of trans-oral vestibular Vs axillo-breast approach in terms of patient satisfaction (cosmesis and postoperative neck discomfort or pain) on a Likert scale of 1 to 5. Timepoint: BEFORE SURGERY AND DAY 1, 10 AND 90 POST SURGERY

—

Secondary

Measure	Time frame
To compare the trans-oral vestibular Vs axillo-breast approach in terms of changes in the levels of inflammatory markers over a period of 3 months and to correlate the inflammatory markers with pain score. To compare the trans-oral vestibular Vs axillo-breast approach in terms of the ease of doing the procedure by the surgeon on a Likert scale of 1 to 5. Timepoint: BEFORE SURGERY AND DAY 1, 10 AND 90 POST SURGERY	—

Measure

Time frame

To compare the trans-oral vestibular Vs axillo-breast approach in terms of changes in the levels of inflammatory markers over a period of 3 months and to correlate the inflammatory markers with pain score. To compare the trans-oral vestibular Vs axillo-breast approach in terms of the ease of doing the procedure by the surgeon on a Likert scale of 1 to 5. Timepoint: BEFORE SURGERY AND DAY 1, 10 AND 90 POST SURGERY

—

Countries

India

Contacts

Public ContactDr Arun Kumar

All India Institute of Medical Sciences

dranitadharbhan@gmail.com9810198239

Outcome results

None listed

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