comparing two methods of surgery for thyroid with no scar on neck

Comparison of outcomes of Trans-oral vestibular and Axillo-breast approach for endoscopic hemithyroidectomy in patients with benign and indeterminate thyroid lesions- A randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044331

Enrollment

136

Registered

2022-07-26

Start date

Unknown

Completion date

Unknown

Last updated

2022-08-02

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

Conditions

Health Condition 1: D34- Benign neoplasm of thyroid gland

Interventions

Intervention1: trans vestibular procedure: hemithyroidectomy will be done through the vestibular route using three ports 10 mm and two 5 mm. Control Intervention1: axillo breast approach: hemithyroide

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >= 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 • All thyroid lesions of size Ë? 5 cm or 40ml • All thyroid lesions involving both lobes of thyroid requiring total thyroidectomy • All malignant lesions of thyroid • Evidence of active clinical hyperthyroidism or thyroiditis • Substernal thyroidal extension of swelling

Design outcomes

Primary

Measure	Time frame
To compare safety and outcomes of trans-oral vestibular vs axillo-breast approach in terms of patient satisfaction in patients undergoing these surgeries for benign and indeterminate thyroid swellings.Timepoint: preoperative 1 day 1 month 3 months	—

Secondary

Measure	Time frame
â?¢To compare the trans-oral vestibular Vs axillo-breast approach in terms of Quality of Life . â?¢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. â?¢To compare the trans-oral vestibular Vs axillo-breast approach in terms of inflammatory response of body to both procedures. â?¢This study will be ambispective combining data from earlier study for safety to compare the outcomes of trans-oral vestibular Vs axillo-breast approach in terms of recurrent laryngeal nerve injury, parathyroid injury, blood loss, pain, respiratory distress, subcutaneous ecchymosis and paresthesia over neck, chin & chest. Timepoint: preoperative 1 day 1 month 3 months	—

Measure

Time frame

â?¢To compare the trans-oral vestibular Vs axillo-breast approach in terms of Quality of Life . â?¢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. â?¢To compare the trans-oral vestibular Vs axillo-breast approach in terms of inflammatory response of body to both procedures. â?¢This study will be ambispective combining data from earlier study for safety to compare the outcomes of trans-oral vestibular Vs axillo-breast approach in terms of recurrent laryngeal nerve injury, parathyroid injury, blood loss, pain, respiratory distress, subcutaneous ecchymosis and paresthesia over neck, chin & chest. Timepoint: preoperative 1 day 1 month 3 months

—

Countries

India

Contacts

Public ContactDrYashwant Kumar Virwadia

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

dranitadharbhan@gmail.com09810198239

Outcome results

None listed

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