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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04423003
Other study ID # 242/2020BO2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date May 15, 2020

Study information

Verified date June 2020
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a combined study including a descriptive part about the preparations for COVID-19 and the impact of COVID-19 on the daily routine of the work in an Interdisciplinary Endoscopic Unit (IEU), and a point-prevalence analysis for possible positive SARS-CoV-2 carriers among the staff of the IEU, and finally a prospective analysis of SARS-CoV-2 positive patients who required endoscopic intervention.

Results are presented in the captures: 1. SARS-CoV-2-pandemic related restructuring of the processes in the IEU, 2. SARS-CoV-2-pandemic related impact on the staff of the IEU, and 3. Analysis of endoscopic interventions in patients with confirmed or suspected SARS-CoV-2 infection.


Description:

This article is intended to provide an overview of the impact of the COVID-19 pandemic on an interdisciplinary endoscopy unit (IEU, gastroenterological endoscopy, surgical endoscopy, and bronchoscopy) at the University Hospital Tübingen, a center for tertiary care in South-western Germany. First, preparations for COVID-19 pandemic with respect to the IEU are presented, and compared with those of other endoscopy units (7, 8). Additionally, the direct impact of SARS-CoV-2 on the staff of the IEU will be shown, together with a point-prevalence analysis of SARS-CoV-2 of the staff at the end of the SARS-CoV-2 wave in Tübingen. Finally, to our knowledge for the first time, we conducted a prospective single center analysis of the patients infected with SARS-CoV-2, which required a diagnostic or therapeutic endoscopic intervention.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 15, 2020
Est. primary completion date May 15, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- patients with proven or suspected infections with SARS-CoV-2 infection, who required endoscopic interventions

Exclusion Criteria:

- all other patients

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Endoscopic intervention
All endoscopic interventions in COVID-19 positive tested patients were included

Locations

Country Name City State
Germany University Hospital of Tuebingen Tuebingen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary death in time of observation death in time of observation 01.March 2020 to 5. May 2020