Increased Risk of SARS-CoronaVirus-2 (SARS-CoV-2) Infection Associated With Endoscopy (DECORE Study) (DECORE)

July 27, 2020 updated by: Marina de Benito Sanz, Hospital del Río Hortega

Prospective Observational Study Evaluating the Increased Risk of SARS-CoronaVirus-2 (SARS-CoV-2) Infection Associated With Endoscopic Procedures (DECORE Study)

The aim of our study to compare the proportion of patients who develop SARS-CoV-2 disease in 3 groups: patients undergoing a abdominal ultrasound examination in a Specialty Center, patients undergoing endoscopic procedure in a third level hospital with CoronaVirus Disease (COVID-19) hospitalization plants and patients who make a telephonic visit (do not go to the hospital) in the digestive system service.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will undergo a telephonic interview 48-96h before the procedure where will ask about the presence of symptoms suggestive of SARS-CoV-2 infection. Optionally, they will also be carried out a scan (PCR) to detect infection 48-96h before procedure, withdrawing from the study patients with positive PCR or infection suspected by clinical data according to the questionnaire, after evaluating the responses to the questionnaire by one of the members of the research team.

Endoscopic examinations will be carried out according to the recommendations of the Spanish Society for Digestive Endoscopy (SEED). The patient will perform a hand wash with solution hydroalcoholic before entering the endoscopy room, and you will be placed a surgical mask and gloves. Staff close to the patient will carry FFP2 mask, exceptionally surgical mask, gown (waterproof in high-risk examinations as established in the SEED guidelines), hat, nitrile gloves and face shield or safety glasses (reusable) and shim covers. The examinations will be carried out using sedation guided by endoscopist according to current clinical guidelines.

Ultrasonographic examinations (US) will be carried out according to clinical guideline. The examinator will wear a filtering face pieces 2 (FFP2) mask, exceptionally surgical mask, gown, cap, nitrile gloves and face shield or goggles safety (reusable) and shoe covers. The gel bottle, the transducer and the gurney will be washed before each US with low level disinfectant.

Patients who meet the inclusion criteria and do not have any exclusion criteria will be invited to participate in the study. The patients who agree to participate will complete the informed consent according to the law 41/2002 of patient autonomy without for that reason alter the relationship with your doctor or cause any harm to your treatment. The monitoring period will have a maximum duration of 17 days. It will consist of a telephone control through a pre-established checklist. In case of any positive answer to the questionnaire, it will be completed the study through the consultation of the investigators by means of a polymerase chain reaction (PCR).

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47012
        • Hospital Rio Hortega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for an ambulatory endoscopy, an ambulatory abdominal ultrasound, or a telephonic visit

Description

Inclusion Criteria:

  • Patients scheduled for an ambulatory endoscopy, an ambulatory abdominal ultrasound, or a telephonic visit Age younger than 18 years.

Exclusion criteria:

Refusal to sign the informed consent Immunosuppression (steroid treatment with a dose of 20 mg or more of prednisone daily, azathioprine, cyclosporine, mercaptopurine, methotrexate, mycophenolate, tacrolimus, everolimus, chemotherapeutic agents, anti-tumoral necrosis factor (TNF)-α drugs or other biological treatments for inflammatory bowel disease) Immunodeficiency due to a non-pharmacological cause (HIV, hematological dyscrasias, primary immunodeficiencies ...) Previous confirmed diagnosis (by PCR or serology) of SARS-CoV-2 disease. Diagnosis of previous suspicion (documented in the medical history by a physician) of SARS-CoV-2 disease.

Previous clinical picture compatible with SARS-CoV-2 in the previous 2 months (defined as any positive response to the check-list questionnaire contained in Annex III) Cognitive impairment or hearing impairment preventing the phone visit Habitual residence outside the province of Valladolid Ultrasound interventionism (liver biopsy, ultrasound-guided paracentesis, biliary drainage ...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endoscopic cohort
Endoscopic examinations: They will be carried out according to the recommendations of the Spanish society for digestive endoscopy (SEED). In summary, the patient will perform a hand wash with hydroalcoholic solution before entering the endoscopy room, and will put on a surgical mask and gloves. Personnel close to the patient will wear an FFP2 mask, exceptionally a surgical mask, a gown (waterproof in high-risk examinations as established in the SEED guidelines), a cap, nitrile gloves and face shield or safety glasses (reusable) and shoe covers. The examinations will be performed by endoscopist-guided sedation in accordance with current clinical guidelines.
Procedure: Gastrointestinal endoscopy
Upper or lower GI endoscopy according to clinical practice and current guidelines
Ultrasonography cohort
Abdominal ultrasound: They will be carried out according to international clinical guidelines (12). The explorer will wear an FFP2 mask, exceptionally a surgical mask, a gown, a hat, nitrile gloves, and a face shield or safety glasses (reusable) and shoe covers. The gel bottle, transducer, and stretcher will be washed prior to each scan with low-level disinfectant
Procedure: Abdominal ultrasound
Diagnostic abdominal ultrasound according to the current guidelines
Telephonic cohort
The patient will be telephonically contacted for a medical visit.
Behavioral: Telephonic medical visit
The patient will receive a telephonic call passing a medical visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 infection in patients
Time Frame: may-june 2020
Proportion of patients who develop SARS-CoV-2 infection in 3 groups: patients undergoing an abdominal ultrasound examination in a Specialty Center, patients undergoing an endoscopic examination in a third-level hospital with hospitalization facilities COVID-19 and patients who make a non-face-to-face consultation (do not go to the hospital) in the digestive system service
may-june 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 infection in HCW
Time Frame: may-june 2020
Number of Health Care Workers (HCW) who develop SARS-CoV-2 infection in endoscopy service in this period
may-june 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Río Hortega

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 11, 2020

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (ACTUAL)

May 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003 (NuSkin International)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on SARS-CoV 2

Clinical Trials on Gastrointestinal endoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe