Safe Discharge in Lower Gastrointestinal Bleeding

Completed

• Conditions: Lower GI Bleeding
• Interventions: Other: Safe discharge

• Registration Number: NCT06409988
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2019-06-01
• Study Completion: 2020-12-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Study First Posted: 2024-05-10
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with lower gastrointestinal bleeding	Safe discharge	Any \>18 years old patient admitted to our hospital due to a lower gastrointestinal bleeding episode.

Primary Outcome Measures

Name	Time	Method
Validation of SHA2PE score in our cohort	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
Safe Discharge	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.

Secondary Outcome Measures

Name	Time	Method
Performance of SHA2PE score in safe discharge	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.
Performance of Oakland score in safe discharge	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.

Trial Locations

Locations (1)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Spain