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

NCT ID: NCT05178186

Last Updated: 2022-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22974 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2022-09-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Thyroid carcinoma

Patients with thyroid carcinoma submitted to thyroidectomy

Group Type: OTHER

Thyroidectomy

Intervention Type: PROCEDURE

Surgery for thyroid carcinoma

Interventions

Thyroidectomy

Surgery for thyroid carcinoma

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Age < 18 yo
• Incidental diagnosis of thyroid carcinoma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cagliari

OTHER

Sponsor Role: lead

Responsible Party

Fabio Medas

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU Cagliari

Cagliari, CA, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 37127041 (View on PubMed)

Other Identifiers

THYCOVID

Identifier Type: -

Identifier Source: org_study_id