Acute PAncreatitis and Home Care vs. Hospital Admission Study

NCT05360797 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2022-05-04

No results posted yet for this study

Summary

Acute pancreatitis (AP) is one of the most common reason for hospitalization among gastrointestinal diseases in U.S.. The costs caused by severe AP are higher than mild AP. Nevertheless, approximately 70% of hospital admissions for AP are mild cases, if health cost saving is to be realized, it would be by lowering the cost of managing patients with mild AP without affecting patient's safety and satisfaction.

With the PADI-1 study, where it was possible to confirm the benefits of an early diet, the rapid recovery of patients with mild AP and the reduction of hospital costs, now a new scope is to be given in the treatment of patients with this pathology.

Considering the application of predictive factors of AP severity, and being sure of diagnosing mild AP, a study of home care versus hospitalization for patients with mild AP is proposed. Based on the hypothesis that outpatient care of mild AP patients would be as sage and affective as hospitalization, the aim this study is to campare the results of 3 different strategies of treatment of patients with AP mild. Additionally, satisfaction patient and costs will be analyzed.

Conditions

Interventions

OTHER

Outpatient

After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.

OTHER

Medical home care

After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.

OTHER

Hospitalization

After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is hospitalized with usual treatment (PADI\_1) in each center.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER
  • Consorci Sanitari del Maresme

    collaborator OTHER
  • Elena Ramírez-Maldonado

    lead OTHER

Principal Investigators

  • Elena Ramírez-Maldonado, PhD · Hospital Universitari Joan XXIII

  • Rosa Jorba-Martin, PhD · Hospital Universitari Joan XXIII

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2022-07-01
Completion
2024-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05360797 on ClinicalTrials.gov