Comparision of patient satisfaction, cosmesis and quality of life in two approaches of parathyroidectomy to identify a best approach.

A randomized controlled trial to compare patient satisfaction, cosmesis, quality of life, safety and feasibility of Endoscopic Parathyroidectomy by Ipsilateral Axillo-Breast approach versus open focussed Parathyroidectomy in patients with primary hyperparathyroidism due to a single gland disease - NILL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075600

Enrollment

Registered

2024-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: E210- Primary hyperparathyroidism

Interventions

Intervention1: Endoscopic parathyroidectomy via ipsilateral axillo breast approach (IABA): Endoscopic parathyroidectomy via ipsilateral axillo-breast approach (IABA) is a minimally invasive surgical p

Eligibility

Inclusion criteria

Inclusion criteria: Biochemically proven cases of Sporadic primary hyperparathyroidism in which only a single parathyroid gland responsible for hyperparathyroidism would be included.

Exclusion criteria

Exclusion criteria: 1. Age below 18 years 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. Multiglandular disease 6. Parathyroid adenoma of size greater than 3 cm. 7. Pregnancy and Lactation

Design outcomes

Primary

Measure	Time frame
1. Pain and discomfort of Patient will be assessed on 5-point likert scale using related questions. 2. Cosmetic assessment will be done by patient using a 4-point likert scale. 3. Cosmetic assessment will be done by a surgeon and a nurse using a 5-point likert scaleTimepoint: 1. ON POD1 AND POD3 2. AT 4 WEEKS 3. AT 4 WEEKS	—

Secondary

Measure	Time frame
1. Surgeon rated ease of doing the procedure will be assessed on a Likert scale of 1 to 5. 2. Post-operative complication - RLN injury via Laryngoscopy 3. Post-operative complication - RLN injury via Voice analysis 4. Post-operative complication - formation of seroma 5. Post-operative complication - subcutaneous ecchymosis 6. Post-operative complication - Respiratory distress 7. Post-operative complication - ParaesthesiaTimepoint: 1. Immediately after the surgery 2. Before surgery & Immediately after surgery 3. On POD10, at 3 months & at 6 months after surgery 4. On POD1, POD2 & after 1 week 5. On POD1 & POD10 6. On POD1 & POD2 7. On POD1 & POD2	—

Measure

Time frame

1. Surgeon rated ease of doing the procedure will be assessed on a Likert scale of 1 to 5. 2. Post-operative complication - RLN injury via Laryngoscopy 3. Post-operative complication - RLN injury via Voice analysis 4. Post-operative complication - formation of seroma 5. Post-operative complication - subcutaneous ecchymosis 6. Post-operative complication - Respiratory distress 7. Post-operative complication - ParaesthesiaTimepoint: 1. Immediately after the surgery 2. Before surgery & Immediately after surgery 3. On POD10, at 3 months & at 6 months after surgery 4. On POD1, POD2 & after 1 week 5. On POD1 & POD10 6. On POD1 & POD2 7. On POD1 & POD2

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Countries

India

Contacts

Public ContactDr Kamal Kataria

All India Institute of Medical Sciences, New Delhi

dryashvant.r@gmail.com9911337726

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026