Thyroid Health Outcomes Registry for Surgery

NCT07812779 | Not Yet Recruiting

• 1 other identifier: THORS
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Thyroid Diseases; Thyroid Neoplasms; Thyroid Cancer; Thyroid Nodules; Goiter; Medullary Thyroid Carcinoma; Thyroid Surgery for Benign Disease; Real-World Data; Adrenal Gland Neoplasms; Adrenal Cancer; Endocrine Surgery; Neck Dissection

Keywords

thyroid surgery; endocrine surgery; thyroidectomy; hemithyroidectomy; completion thyroidectomy; cervical lymph node dissection; thyroid cancer; differentiated thyroid carcinoma; medullary thyroid carcinoma; postoperative complications; real-world data; RWD; observational cohort; data quality; clinical phenotyping; COS-DTC

Outcome Measures

Primary Outcomes (2)

• 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.

  Within 30 days after each index thyroid operation

• 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.

  Up to 30 days after the index thyroid operation

Secondary Outcomes (13)

• 30-Day Mortality

  Within 30 days after index thyroid surgery

• Permanent Recurrent Laryngeal Nerve Palsy Due to Surgery

  12 months after the index operation

• Permanent Postoperative Hypoparathyroidism

  12 months after the index operation

• Percentage of Index Operations in Each Final Histopathologic Diagnosis Category

  Up to 90 days after the index thyroid operation

• Percentage of Participants With Persistent Differentiated Thyroid Carcinoma at 12 Months

  12 months after the index thyroid operation

Other Outcomes (3)

• Percentage of Required Real-World Data Elements With Available Values

  At each annual data freeze, up to 5 years

• Percentage of Operation Records Requiring Manual Clinical Review

  At each annual validation cycle, up to 5 years

• Percentage of the 13 Core Outcome Set for Differentiated Thyroid Carcinoma Domains Classified as Analytically Resolvable

  At each annual data freeze, up to 5 years

Study Arms (1)

Patients Undergoing Thyroid Surgery

Patients undergoing surgery involving the thyroid gland for benign or malignant thyroid disease at Moscow Multidisciplinary Clinical Center "Kommunarka". The cohort includes primary, completion, and repeat operations and is updated as new eligible patients and follow-up information become available. Routine-care thyroid surgery. The type and extent of surgery are determined by the treating clinical team according to routine care and are not assigned by the research protocol. Procedures may include hemithyroidectomy, thyroidectomy, completion thyroidectomy, repeat thyroid surgery, central and/or lateral cervical lymph-node dissection, and other clinically indicated thyroid-related procedures. No protocol-assigned comparator. Comparisons between naturally occurring clinical strategies may be performed in prespecified observational substudies with appropriate control of confounding and assessment of positivity.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Procedure predominantly involving the parathyroid glands without a confirmed relationship to thyroid disease.
• 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.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

MeSH Terms

Conditions

Thyroid Diseases; Thyroid Neoplasms; Thyroid Nodule; Goiter; Carcinoma, Medullary; Adrenal Gland Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue; Adrenal Gland Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• сергей Мосин

  Pirogov University (RNRMU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey V. Mosin, PhD

CONTACT

+79163790717; mosin-sergey@yandex.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 31, 2032
• Study Completion (Estimated): January 31, 2032
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share