Home Treatment of Acute Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-06-30

Brief Summary

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Acute pancreatitis (AP) is considered a disease requiring in-hospital treatment. We studied the feasibility of home management in AP.The aim of study was to compare 30 day readmission rates in patients with mild non-alcoholic acute pancreatitis (NAAP) randomized to home monitoring versus hospitalization.

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Detailed Description

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Between 11/11-5/12, 84 patients with mild NAAP were randomized to home or hospital groups after a short (≤24 hours) hospital stay. AP was defined as ≥2 or more of the following: characteristic abdominal pain, amylase and/or lipase ≥3X the upper limit of normal, and/or imaging findings. Patients with an Imrie's score ≤5 and a harmless acute pancreatitis score (HAPS) ≤2 were included. Patients in both groups received intravenous lactated Ringer for 3 days and pain was treated with intramuscular diclofenac. A nurse visited all patients in the home group on the 2nd, 3rd and 5th day. All patients recalled for follow-up on the 7th, 14th, and 30th days.

Conditions

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Acute Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Home and hospital treatment groups

Patients were randomized into either home or hospital groups after a brief hospitalization(≤24 hours. Hospital patients were followed 5 days in hospital.Home patients were visited on 2nd,3rd and 5th days by a staff nurse and the vital signs, symptoms, and general condition were recorded and transmitted back to the attending physician. On the 7th, 14th and 30th days, the home and hospital group patients were requested to return for a follow-up clinic visit at Bezmialem, at which time an assessment of their symptoms, physical examination, and laboratory evaluation was conducted.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of AP based on 2 out of 3 findings: characteristic abdominal pain, amylase and/or lipase levels ≥3 times the upper limit of normal, and/or abdominal imaging demonstrating changes of acute pancreatitis
* Presentation within 48 hours of symptom onset
* Imrie's scores of ≤5 and HAP score ≤2 within 24 hours of presentation to the hospital
* Lack of hemoconcentration (hematocrit ≥44%) on presentation since hemoconcentration has been shown to be a risk factor for pancreatic necrosis.

Exclusion Criteria

* The presence of organ failure by the Atlanta criteria on the first day of presentation
* The presence of clinical signs and/or symptoms of sepsis
* Alcoholic acute pancreatitis
* A history of abdominal imaging demonstrating a dilated pancreatic duct and/or pancreatic calcifications
* Coagulopathy (international normalized ratio \>1, and/or platelet count \<50,000/mm3
* Comorbidities requiring hospitalization regardless of the presence of AP e.g. acute myocardial infarction, malignancy, cirrhosis, chronic kidney disease, and chronic pulmonary disease)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No