Outcomes of Covid-19 Protective Measures in Endoscopy

Covid-19 Disease Clinical Trial

Official title:

Outcomes After Implementation of a Protective Protocol for Covid-19 in Large Spanish Endoscopy Units.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04371354
• Other study ID #: 2020-COCHE
• Status: Active, not recruiting
• Start date: April 27, 2020
• Est. completion date: December 27, 2021

Study information

• Verified date: August 2021
• Source: Fundacion Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective study evaluating the outcomes of implementation of a protective protocol for Covid-19 for patients and staff in a large endoscopy unit.

Description:

Detailed description: SARS-Covid-19 virus pandemic has had a big impact both socially and on operation of health facilities. During the Covid-19 outbreak most of the scheduled endoscopies were cancelled and only emergent and urgent endoscopies were performed in the unit. This meant that for six weeks, around 98% of our daily workload was cancelled. During that time the investigators have developed a protocol in order to resume scheduled endoscopic activity in the decreasing phase of the pandemic.

The hypothesis of this prospective observational study is that implementation of a protocol based upon Covid PCR tests and clinical triage is useful to categorize two types of Covid-19 infection risk and two levels of personal protection equipments required.

The primary aim is to evaluate the outcomes of implementing a protective protocol with two levels of protection for Covid-19 in the endoscopy unit. As secondary aims, the investigators, want to evaluate the endoscopy unit staff and patients infection rate after implementation of the protective protocol; and the utility of previous Covid PCR testing and on day clinical triage to discriminate patients before endoscopy.

A brief daily questionnaire will be filled by all the endoscopy unit staff members questioning about type of procedures performed in their allocated endoscopy room, level of protection used and PCR status of their attended patients. Patients will be followed up for a period of two weeks to discard development of Covid-19 disease with possible origin in their visit to the endoscopy unit.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 27, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing an endoscopic procedure with written informed consent given.

• Staff allocated in the endoscopy unit.

Exclusion Criteria:

• Refection to participate in the study.

Related Conditions & MeSH terms

• Covid-19 Disease
• Endoscopy Unit

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of new Covid infection of patients and staff members	Number of new Covid infection of patients and staff members	3 months
Secondary	Covid disease prevalence in the patients referred to endoscopy	Number of patients referred to endoscopy with Covid disease	3 months
Secondary	Categorization by clinical triage and Covid Test	Categorization of patients by clinical triage and Covid Test	3 months
Secondary	Type of endoscopy procedure and staff protective equipment	Influence of the type of endoscopy procedure and staff protective equipment	3 months