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

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.

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).

Completed
SARS-CoV 2
COVID

Behavioral: Telephonic medical visit

The patient will receive a telephonic call passing a medical visit

Procedure: Gastrointestinal endoscopy

Upper or lower GI endoscopy according to clinical practice and current guidelines

Procedure: Abdominal ultrasound

Diagnostic abdominal ultrasound according to the current guidelines

Eligibility Criteria

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 ...)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

Hospital Rio Hortega
Valladolid, Spain

Hospital del Río Hortega
NCT Number
Keywords
Covid
SARS-CoV 2
Endoscopy
MeSH Terms
Infections
Coronavirus Infections