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Protocol for Randomized Controlled Trial Comparing Long-Term Health-Related Quality of Life (HRQoL) Between Endoscopic Thyroidectomy (ETx) and Open Thyroidectomy (OTx) Using ThyPRO-39 Questionnaire

Comparison of Long-Term Health-Related Quality of Life Between Endoscopic and Open Thyroidectomy for benign thyroid nodules: A Randomized Controlled Trial Using ThyPRO-39 Questionnaire (ELEVATE Trial: Endoscopic vs. Open Thyroidectomy Long-Term HEalth-Related QuALity of Life Using ThyPRO-39) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089405
Enrollment
106
Registered
2025-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: Transoral endoscopic thyroidectomy: Patient in this group will undergo endoscopic thyroid surgery Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5:

Sponsors

Netaji Subhash Chandra Bose Medical College Jabalpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Indication for thyroidectomy: benign nodules No prior thyroid or neck surgery.

Exclusion criteria

Exclusion criteria: - Contraindications for general anesthesia. - Thyroid malignancy - Incomplete follow-up at 12 months post-surgery.

Design outcomes

Primary

MeasureTime frame
The trial is expected to clarify the long-term HRQoL differences between ETx and OTx, providing evidence for selecting surgical techniques based on patient-centered outcomes HRQoL at 12 months post-surgery assessed by ThyPRO-39. Rates of hypoparathyroidism, RLN palsyTimepoint: Baseline, 6 months and 12 months

Secondary

MeasureTime frame
Rates of hypoparathyroidism, RLN palsyTimepoint: 12 Months

Countries

India

Contacts

Public ContactDr Sanjay Kumar Yadav

NSCB Medical College Jabalpur MP

drpawanagarwal@yahoo.com

Outcome results

None listed

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