The Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Upper Gastrointestinal Bleeding

March 3, 2020 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Observational Study About the Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Gastrointestinal Bleeding

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1320

Contacts and Locations

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

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: During the years 2017 and 2018
In-hospital mortality and at 30 days after early gastroscopy will be assessed through clinical history observation, within the study period
During the years 2017 and 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Entry Duration
Time Frame: During the years 2017 and 2018
The time between admission and discharge
During the years 2017 and 2018
Signs of bleeding activity in a period of less than 12 h. post gastroscopy early.
Time Frame: During the years 2017 and 2018
It will be evaluated using the Rockall scale
During the years 2017 and 2018
Type of endoscopic treatments
Time Frame: During the years 2017 and 2018
Hemostasis can be performed by applying different techniques or a combination of them
During the years 2017 and 2018

Collaborators and Investigators

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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Principal Investigator: Luzdivina Perez Garcia, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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)

October 28, 2019

Primary Completion (Anticipated)

October 28, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-FIN-2018-50

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.

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