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Completed

NCT Number: NCT06409988

Safe Discharge in Lower Gastrointestinal Bleeding

The increasing incidence in lower gastrointestinal bleeding (LGIB) leads to a rise in hospital admission. Many LGBI are self-limiting thus the several scores to identify low risk patients suited to outpatient care have been described. We aim to compare two of this scores (Oakland score and SHA2PE score) in terms of performace to predict "safe discharge" from the emergency department.

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Key information

Conditions

Lower GI Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

About this study

The growing incidence of lower gastrointestinal bleeding (LGIB) is leading to a rise in hospital admissions even though most LGIB episodes are self-limiting. The Oakland and SHA2PE scores were designed to identify patients best suited to outpatient care. Our aim is to validate the SHA2PE score and compare both of these scores in terms of predictiveness of safe discharge.

We conducted a retrospective observational study of LGIB patients admitted to our hospital between June 2014-June 2019. During this period, data from all LGIB episodes admitted from the ED were collected in an electronic anonymized database created specifically for this study. If any of the principal variables or critical information was missing, the patient was excluded from the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All > 18 year old patients, male and women, admitted to our hospital between June 2014 and June 2019 because of LGIB (lower gastrointestinal bleeding).

Exclusion criteria

  • Patients in whom LGIB occurred while already admitted for an other cause.
  • Patients with LGIB transferred from another hospital due to comorbidities or severity of the gastrointestinal bleeding episode.
  • Patients with post-polypectomy LGIB (endoscopic polypectomy <14 days before admission).
  • Patients with gastrointestinal bleeding of unknown origin after a complete study.
  • Patients who had undergone digestive tract surgery in the previous month.
  • Patients with an ostomy.
  • Patients with known colorectal cancer who had not undergone surgery.

Treatment and study plan

Safe discharge

Other

There was no specific intervention, we only aimed to see if those admitted patients could have been safely dicharged from the emergency department.

Primary outcomes

  1. Safe Discharge

    Time frame: After 1 month of follow-up from the hospital discharge

    Patients with lower gastrointestinal bleeding and absence of all the following: rebleeding, re-consulting for LGIB within 28 days after discharge, in-hospital mortality, requirement of red blood cell transfusion or endoscopic, radiological, or surgical haemostatic treatment.

  2. Validation of SHA2PE score in our cohort

    Time frame: After 1 month of follow-up from the hospital discharge

    We aim to validate this score in a southern Europe cohort and compare it to the Oakland score

Secondary outcomes

  1. Performance of Oakland score in safe discharge

    Time frame: After 1 month of follow-up from the hospital discharge

    We calculated the sensibility, specificity, positive and negative predictive values of the Oakland score in our patients cohort.

  2. Performance of SHA2PE score in safe discharge

    Time frame: After 1 month of follow-up from the hospital discharge

    We calculated the sensibility, specificity, positive and negative predictive values of the SHA2PE score in our patients cohort.

Other outcomes

  1. Demographic characterisctics of our cohort

    Time frame: After 1 month of follow-up from the hospital discharge

    Description of the main characteristics of the patients admitted due to lower gastrointestinal bleeding

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study title

External Validation of the SHA2PE Score and Its Comparison to the Oakland Score for the Prediction of Safe Discharge in Patients With Lower Gastrointestinal Bleeding

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
May 10, 2024
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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