Outcomes of Covid-19 Protective Measures in Endoscopy

• Conditions: Covid-19 Disease; Endoscopy Unit

• Registration Number: NCT04371354
• Lead Sponsor: Fundacion Miguel Servet

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-04-27
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-05-01
• Primary Completion: 2021-06-14
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08
• Study Completion: 2021-12-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of new Covid infection of patients and staff members	3 months	Number of new Covid infection of patients and staff members

Secondary Outcome Measures

Name	Time	Method
Type of endoscopy procedure and staff protective equipment	3 months	Influence of the type of endoscopy procedure and staff protective equipment
Covid disease prevalence in the patients referred to endoscopy	3 months	Number of patients referred to endoscopy with Covid disease
Categorization by clinical triage and Covid Test	3 months	Categorization of patients by clinical triage and Covid Test

Trial Locations

Locations (1)

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain