In buttonhole surgery for thyroid gland swelling,which approach results in better quality of life,one which involves skin cut on one side of axilla & breast or the one which involves skin cut on both sides of axilla and breast.

A randomized controlled trial to compare the quality of life between axillo-breast approach & bilateral axillo-breast approach for endoscopic thyroidectomy in patients with benign thyroid swellings

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063405

Enrollment

Registered

2024-03-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: E049- Nontoxic goiter, unspecified

Interventions

Intervention1: Endoscopic thyroidectomy by Axillo Breast Approach: Patient will undergo surgery via ipsilateral axilla and Breast.Total duration will be 2 years Control Intervention1: Endoscopic thyro

Eligibility

Inclusion criteria

Inclusion criteria: 1.age above 18 years 2. Benign or cytologically indeterminate lesions involving single or both lobes of size less or equal to 5 cm or 40 ml.

Exclusion criteria

Exclusion criteria: 1.All thyroid lesions of size greater than 5 cm or 40 ml. 2.all malignant lesions of thyroid 3.evidences of active clinical hyperthyroidism or thyroiditis 4.previous history of head and neck surgery and irradiation 5.substernal thyroid extension of swelling. 6.all thyroid lesions requiring total thyroidectomy.

Design outcomes

Secondary

Measure	Time frame
1.To compare the Axillobreast approach & bilateral Axillobreast approach in terms of the ease of doing the procedure by the surgeon. 2.To compare the safety of Axillobreast approach & bilateral Axillobreast approach in terms of complications 3.To compare the Axillobreast approach & bilateral Axillobreast approach in terms of conversation to open thyroidectomy.Timepoint: On operating table. Then at 2weeks, 6 weeks & 12 weeks	—

Measure

Time frame

1.To compare the Axillobreast approach & bilateral Axillobreast approach in terms of the ease of doing the procedure by the surgeon. 2.To compare the safety of Axillobreast approach & bilateral Axillobreast approach in terms of complications 3.To compare the Axillobreast approach & bilateral Axillobreast approach in terms of conversation to open thyroidectomy.Timepoint: On operating table. Then at 2weeks, 6 weeks & 12 weeks

—

Primary

Measure	Time frame
Quality of life will be assessed by two questionnaires, WHO SF36 questionnaire and thyroid specific questionnaireTimepoint: Questionnaires at 2 weeks,6 weeks and 12 weeks	—

Countries

India

Contacts

Public ContactShahidul Haq dar

All India institute of medical sciences

drkamalkataria@gmail.com9212678920

Outcome results

None listed

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