Clinical trial NCT04296435: The Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Upper Gastrointestinal Bleeding
Official title: Observational Study About the Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Upper Gastrointestinal Hemorrhage
Keywords: Weekend effect
non-varicose upper gastrointestinal bleeding
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 1320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with non-varicose upper gastrointestinal bleeding and admitted to the Bleeding Unit of the Santa Creu and Sant Pau hospital during 2017 and 2018 to perform an early gastroscopy. In addition, patients must meet the following inclusion and exclusion criteria.

Brief summary: The hypothesis is that the mortality of patients with non-varicose upper gastrointestinal bleeding after performing early gastroscopy who are admitted on weekends and night hours is higher than those admitted on weekdays or during daytime hours.

Detailed description: The aim of the study is to evaluate the impact of the schedule (day or night) and the day of admission (working or weekend / night) on the mortality of patients with non-varicose upper gastrointestinal bleeding after performing an early gastroscopy.

A retrospective observational study will be carried out in patients admitted to the bleeding unit of the Santa Creu I Sant Pau Hospital, where we observed hospital mortality and 30 days after performing an early gastroscopy, the duration of admission, signs of hemorrhagic activity in a period of less than 12 h. After early gastroscopy and types of endoscopic treatments, data will be collected by reviewing medical records.

The number of patients expected to be included in this study is 1320 patients. Patients will be included the day they enter the bleeding unit for an early gastroscopy.

Eligibility criteria: Inclusion criteria:

* Patients older than 18 years.
* Patients admitted to the Bleeding Unit with a diagnosis of upper gastrointestinal bleeding.
* Patients who have undergone an early endoscopy to determine the source of bleeding.
* In case of readmissions during the study period, we consider only the admission closest to his death or discharge.

Exclusion criteria:

* Patients diagnosed with gastrointestinal bleeding varicose.
* Patients who present with gastrointestinal bleeding and did not perform early gastroscopy (during the first 24 hours)
* Patients admitted for different medical conditions, who developed upper gastrointestinal bleeding during the course of hospital stay.

Primary outcomes:
measure: Mortality
timeFrame: During the years 2017 and 2018
Secondary outcomes:
measure: Entry Duration
timeFrame: During the years 2017 and 2018
measure: Signs of bleeding activity in a period of less than 12 h. post gastroscopy early.
timeFrame: During the years 2017 and 2018
measure: Type of endoscopic treatments
timeFrame: During the years 2017 and 2018
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Luzdivina Perez Garcia
role: PRINCIPAL_INVESTIGATOR
References: