NCT04635813

Brief Summary

Italy has been on the frontline of the COVID-19 pandemic, caused by the coronavirus SARS-CoV-2, the need to focus resources to deal with the pandemic led to a disruption of routine surgical care, as well as activity for oncologic and chronic disease. The aim of this study was to evaluate the impact of COVID-19 pandemic on surgical activity of the Italian Units of Endocrine Surgery belonging to the SIUEC (Italian Society of Endocrine Surgery), the most important national scientific society of endocrine surgery.The aim of this study was to evaluate the impact of COVID-19 pandemic on surgical activity of the Italian Units of Endocrine Surgery belonging to the SIUEC (Italian Society of Endocrine Surgery), the most important national scientific society of endocrine surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

November 17, 2020

Last Update Submit

November 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quantify the overall reduction of surgical activity for thyroid disease

    1 year

Secondary Outcomes (2)

  • Quantify if the number of thyroid cancers operated during COVID-19 pandemic was significant different from the number of patients operated during the same period of the previous year

    1 year

  • Quantify the number of aggressive tumors operated during COVID-19 pandemic and the same period of the previous year

    1 year

Study Arms (2)

Group 1 - COVID group

Patients that underwent surgery during COVID-19 pandemic

Procedure: Thyroidectomy

Group 2 - control group

Patients that underwent surgery during 2019

Procedure: Thyroidectomy

Interventions

ThyroidectomyPROCEDURE

Thyroidectomy

Group 1 - COVID groupGroup 2 - control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with thyroid disease

You may qualify if:

  • patients that had undergone thyroidectomy during COVID-19 pandemic (from the 9th March to the 31st August 2020), defined as case group, or during the same period of the previous year (from the 9th Match to the 31st August 2019), defined as control group.

You may not qualify if:

  • incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Cagliari

Cagliari, CA, 09100, Italy

Location

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 19, 2020

Study Start

March 10, 2020

Primary Completion

September 30, 2020

Study Completion

November 12, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations