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Safe Discharge in Lower Gastrointestinal Bleeding

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06409988
Enrollment
398
Registered
2024-05-10
Start date
2014-06-01
Completion date
2020-12-30
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower GI Bleeding

Keywords

Discharge, lower gastrointestinal bleeding, Oakland score, SHA2PE score

Brief summary

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.

Detailed description

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.

Interventions

OTHERSafe discharge

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

Sponsors

Germans Trias i Pujol Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Safe DischargeAfter 1 month of follow-up from the hospital dischargePatients 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.
Validation of SHA2PE score in our cohortAfter 1 month of follow-up from the hospital dischargeWe aim to validate this score in a southern Europe cohort and compare it to the Oakland score

Secondary

MeasureTime frameDescription
Performance of Oakland score in safe dischargeAfter 1 month of follow-up from the hospital dischargeWe calculated the sensibility, specificity, positive and negative predictive values of the Oakland score in our patients cohort.
Performance of SHA2PE score in safe dischargeAfter 1 month of follow-up from the hospital dischargeWe calculated the sensibility, specificity, positive and negative predictive values of the SHA2PE score in our patients cohort.

Other

MeasureTime frameDescription
Demographic characterisctics of our cohortAfter 1 month of follow-up from the hospital dischargeDescription of the main characteristics of the patients admitted due to lower gastrointestinal bleeding

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026