Increased Risk of SARS-CoronaVirus-2 (SARS-CoV-2) Infection Associated With Endoscopy (DECORE Study) (DECORE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04401033|
Recruitment Status : Completed
First Posted : May 26, 2020
Last Update Posted : July 28, 2020
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|Condition or disease||Intervention/treatment|
|SARS-CoV 2 COVID||Behavioral: Telephonic medical visit Procedure: Gastrointestinal endoscopy Procedure: Abdominal ultrasound|
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 [Patient Registry]|
|Actual Enrollment :||450 participants|
|Target Follow-Up Duration:||2 Months|
|Official Title:||Prospective Observational Study Evaluating the Increased Risk of SARS-CoronaVirus-2 (SARS-CoV-2) Infection Associated With Endoscopic Procedures (DECORE Study)|
|Actual Study Start Date :||May 11, 2020|
|Actual Primary Completion Date :||June 30, 2020|
|Actual Study Completion Date :||June 30, 2020|
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
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
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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Patients scheduled for an ambulatory endoscopy, an ambulatory abdominal ultrasound, or a telephonic visit Age younger than 18 years.
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 ...)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401033
|Hospital Rio Hortega|
|Valladolid, Spain, 47012|
Documents provided by Marina de Benito Sanz, Hospital del Río Hortega:
|Responsible Party:||Marina de Benito Sanz, Principal co-investigator, Hospital del Río Hortega|
|Other Study ID Numbers:||
|First Posted:||May 26, 2020 Key Record Dates|
|Last Update Posted:||July 28, 2020|
|Last Verified:||July 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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