Clinical trial NCT06409988: Safe Discharge in Lower Gastrointestinal Bleeding
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower GI Bleeding
Keywords: Discharge
lower gastrointestinal bleeding
Oakland score
SHA2PE score
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 398
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: The patients will be selected after discharge from hospitalization in the gastroenterology department during the stablished time period.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safe Discharge
timeFrame: After 1 month of follow-up from the hospital discharge
measure: Validation of SHA2PE score in our cohort
timeFrame: After 1 month of follow-up from the hospital discharge
Secondary outcomes:
measure: Performance of Oakland score in safe discharge
timeFrame: After 1 month of follow-up from the hospital discharge
measure: Performance of SHA2PE score in safe discharge
timeFrame: After 1 month of follow-up from the hospital discharge
Other outcomes:
measure: Demographic characterisctics of our cohort
timeFrame: After 1 month of follow-up from the hospital discharge
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
Study officials:
References:
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citation: Hreinsson JP, Sigurdardottir R, Lund SH, Bjornsson ES. The SHA2PE score: a new score for lower gastrointestinal bleeding that predicts low-risk of hospital-based intervention. Scand J Gastroenterol. 2018 Dec;53(12):1484-1489. doi: 10.1080/00365521.2018.1532019. Epub 2018 Nov 20.