Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer

NCT05178186 | Completed DMC

• 1 other identifier: THYCOVID
• Study Type: interventional
• Target: 22,974
• Locations: 1 country
• Sites: 1

Brief Summary

The impact of the COVID-19 pandemic has heavily influenced routine medical care. In the first months of the pandemic, healthcare authorities restricted medical care to emergency procedures, postponing elective surgical activity. Conversely, screening programmes and planned examinations have been temporarily suspended or delayed. Gradually, elective surgery and clinical activities have resumed, thanks to the weakening of the pandemic, to a better organization of the healthcare systems and to the diffusion of COVID-19 vaccines. In the present study, we aim to evaluate the impact of the COVID-19 pandemic on surgery for thyroid carcinoma. Particularly, we aim to investigate whether the delay in operations, screening programmes, and planned examinations for patients under follow-up after thyroid surgery have led to an increased number of aggressive tumours. To evaluate this aspect, we aim to compare the patients who had undergone thyroidectomy for thyroid cancer before the COVID-19 pandemic (from February 2019 to February 2020), during the first phase of the pandemic (from March 2020 to September 2020), and after the first phase of the COVID-19 pandemic (from October 2020 to October 2021).

Conditions

Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of aggressive thyroid cancers

  Increase in the number of patients with aggressive thyroid carcinoma (intermediate and high risk of local recurrence, according to 2015 American Thyroid Association Guidelines on Thyroid Carcinoma), calculated as ratio between patients with aggressive thyroid carcinoma operated in pre-pandemic period and patients with aggressive thyroid carcinoma operated during covid-19 pandemic.

  36 months

Study Arms (1)

Thyroid carcinoma

OTHER

Patients with thyroid carcinoma submitted to thyroidectomy

Procedure: Thyroidectomy

Interventions

Thyroidectomy PROCEDURE

Surgery for thyroid carcinoma

Thyroid carcinoma

Eligibility Criteria

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

You may qualify if:

• Patients who have undergone thyroidectomy with preoperative diagnosis of thyroid cancer (cytological diagnosis, including Bethesda III, IV, IV or VI class, or high suspicion of thyroid carcinoma based on clinical and/or ultrasonographic features) during the study period (from February 2019 to October 2021)
• Patients who underwent reoperative neck surgery for local recurrence of thyroid carcinoma during the study period (from February 2019 to October 2021)

You may not qualify if:

• Age \< 18 yo
• Incidental diagnosis of thyroid carcinoma

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

AOU Cagliari

Cagliari, CA, 09100, Italy

Location

Related Publications (1)

• Medas F, Dobrinja C, Al-Suhaimi EA, Altmeier J, Anajar S, Arikan AE, Azaryan I, Bains L, Basili G, Bolukbasi H, Bononi M, Borumandi F, Bozan MB, Brenta G, Brunaud L, Brunner M, Buemi A, Canu GL, Cappellacci F, Cartwright SB, Castells Fuste I, Cavalheiro B, Cavallaro G, Chala A, Chan SYB, Chaplin J, Cheema MS, Chiapponi C, Chiofalo MG, Chrysos E, D'Amore A, de Cillia M, De Crea C, de Manzini N, de Matos LL, De Pasquale L, Del Rio P, Demarchi MS, Dhiwakar M, Donatini G, Dora JM, D'Orazi V, Doulatram Gamgaram VK, Eismontas V, Kabiri EH, El Malki HO, Elzahaby I, Enciu O, Eskander A, Feroci F, Figueroa-Bohorquez D, Filis D, Francois G, Frias-Fernandez P, Gamboa-Dominguez A, Genc V, Giordano D, Gomez-Pedraza A, Graceffa G, Griffin J, Guerreiro SC, Gupta K, Gupta KK, Gurrado A, Hajiioannou J, Hakala T, Harahap WA, Hargitai L, Hartl D, Hellmann A, Hlozek J, Hoang VT, Iacobone M, Innaro N, Ioannidis O, Jang JHI, Xavier-Junior JC, Jovanovic M, Kaderli RM, Kakamad F, Kaliszewski K, Karamanliev M, Katoh H, Kosec A, Kovacevic B, Kowalski LP, Kralik R, Yadav SK, Kumorova A, Lampridis S, Lasithiotakis K, Leclere JC, Leong EKF, Leow MK, Lim JY, Lino-Silva LS, Liu SYW, Llorach NP, Lombardi CP, Lopez-Gomez J, Lori E, Quintanilla-Dieck L, Lucchini R, Madani A, Manatakis D, Markovic I, Materazzi G, Mazeh H, Mercante G, Meyer-Rochow GY, Mihaljevic O, Miller JA, Minuto M, Monacelli M, Mulita F, Mullineris B, Munoz-de-Nova JL, Muradas Girardi F, Nader S, Napadon T, Nastos C, Offi C, Ronen O, Oragano L, Orois A, Pan Y, Panagiotidis E, Panchangam RB, Papavramidis T, Parida PK, Paspala A, Perez OV, Petrovic S, Raffaelli M, Ramacciotti CF, Ratia Gimenez T, Rivo Vazquez A, Roh JL, Rossi L, Sanabria A, Santeerapharp A, Semenov A, Seneviratne S, Serdar A, Sheahan P, Sheppard SC, Slotcavage RL, Smaxwil C, Kim SY, Sorrenti S, Spartalis E, Sriphrapradang C, Testini M, Turk Y, Tzikos G, Vabalayte K, Vargas-Osorio K, Vazquez Renteria RS, Velazquez-Fernandez D, Vithana SMP, Yucel L, Yulian ED, Zahradnikova P, Zarogoulidis P, Ziablitskaia E, Zolotoukho A, Calo PG; THYCOVID Collaboration Group. Effect of the COVID-19 pandemic on surgery for indeterminate thyroid nodules (THYCOVID): a retrospective, international, multicentre, cross-sectional study. Lancet Diabetes Endocrinol. 2023 Jun;11(6):402-413. doi: 10.1016/S2213-8587(23)00094-3. Epub 2023 Apr 28.

  PMID: 37127041 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 5, 2022
• Study Start: June 20, 2022
• Primary Completion: July 31, 2022
• Study Completion: September 15, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)