About this trial
THORS is a single-center ambidirectional observational cohort study conducted at Moscow Multidisciplinary Clinical Center "Kommunarka". The study combines retrospective analysis of routinely collected clinical data from patients who underwent thyroid surgery beginning in January 2023 with ongoing prospective accrual of new eligible patients and longitudinal updating of follow-up information. No diagnostic or therapeutic intervention is assigned by the research protocol; all treatment decisions are made as part of routine clinical care. The program evaluates the structure and outcomes of thyroid surgery, postoperative complications, histopathology, repeat and completion procedures, long-term oncologic and functional outcomes, health-care resource use, and the quality and reproducibility of real-world data. Applicable outcomes from the international Core Outcome Set for surgical treatment of differentiated thyroid carcinoma (COS-DTC) are incorporated where they can be reliably measured. The first frozen historical analytical baseline includes 968 unique patients and 1,017 thyroid operations performed from 06 January 2023 through 13 February 2026. The cohort remains open to ongoing enrollment and follow-up
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient undergoes or previously underwent an operation involving the thyroid gland at the study institution during the study period.
The operation was performed for a benign or malignant thyroid disease, including primary, completion, or repeat thyroid surgery.
Source data permit linkage of the patient, hospitalization, operation, and index date.
For a specific substudy, the participant/episode meets the additional prespecified requirements for the relevant exposure and outcome.
Disqualifiers
Procedure or record without a confirmed relationship to thyroid disease.
Technical duplicate record.
Episode for which the essential temporal sequence or index date cannot be established for the relevant analysis.
Record lacking the minimum data required to determine the primary outcome of the specific substudy.
Trial population
Patients treated surgically for benign or malignant thyroid disease at a single multidisciplinary medical center in Moscow. The population is identified from routine clinical-care data and includes historical patients as well as newly accrued eligible patients. Primary, completion, and repeat thyroid operations are eligible when the relevant data can be linked and the episode meets the specific substudy requirements.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Clinically Verified 30-Day Postoperative Complication Rate
Proportion of index thyroid operations followed by at least one clinically verified postoperative complication within 30 days, using prespecified event definitions, multiple routine-care sources where available, and expert adjudication. Complication types are reported separately and may include hypocalcemia/hypoparathyroidism, recurrent laryngeal nerve dysfunction, hematoma/bleeding, infection, chyle leak, unplanned reoperation, organ injury, readmission, and other clinically relevant events.
Percentage of Participants With an Unplanned Reoperation Related to Thyroid Surgery Within 30 Days
The number of unique participants who undergo at least one unplanned surgical reoperation related to the index thyroid operation within 30 days will be divided by the number of participants with ascertainable 30-day follow-up and multiplied by 100. Planned completion thyroidectomy is classified separately and is not counted as an unplanned reoperation.
Secondary outcomes
30-Day Mortality
All-cause death within 30 days of the index thyroid operation, using available in-hospital and post-discharge sources.
Permanent Recurrent Laryngeal Nerve Palsy Due to Surgery
Persistent postoperative vocal-fold dysfunction attributable to surgery at 12 months, with preoperative dysfunction, tumor invasion, and intentional nerve resection considered separately.
Permanent Postoperative Hypoparathyroidism
Persistent postoperative parathyroid dysfunction at 12 months based on prespecified biochemical and treatment criteria.
Percentage of Index Operations in Each Final Histopathologic Diagnosis Category
Among index operations with a valid final pathology report, the number of operations assigned to each prespecified mutually exclusive diagnosis category will be divided by the total number of operations with valid final pathology and multiplied by 100. Categories are differentiated thyroid carcinoma, medullary thyroid carcinoma, other malignant thyroid neoplasm, benign thyroid neoplasm, non-neoplastic thyroid disease, and other or indeterminate pathology.
Other outcomes
Percentage of Required Real-World Data Elements With Available Values
At each annual data freeze, the number of available values across the prespecified required data elements and eligible operation records will be divided by the total number of expected values for those elements and records and multiplied by 100. Missing, not assessed, not applicable, structurally unavailable, and contradictory values will remain distinguishable in the data-quality report.
Percentage of Operation Records Requiring Manual Clinical Review
At each validation cycle, the number of eligible operation records referred for manual clinical review because of missing, conflicting, ambiguous, or rule-discordant information will be divided by the total number of eligible operation records evaluated in that cycle and multiplied by 100.
Percentage of the 13 Core Outcome Set for Differentiated Thyroid Carcinoma Domains Classified as Analytically Resolvable
At each annual data freeze, each of the 13 Core Outcome Set for Differentiated Thyroid Carcinoma domains will be classified using a prespecified binary readiness rule. A domain is analytically resolvable only when its definition, eligible population, assessment window, data source, and participant-level outcome status can be determined for the planned analysis. The number of resolvable domains will be divided by 13 and multiplied by 100.
Locations
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