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Completed

NCT Number: NCT01796652

Home Treatment of Acute Pancreatitis

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakıf University Hospital, Gastroenterology Clinic

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. The primary outcome of the study was the 30 day hospital readmission rate.

    Time frame: 30 days

    30 day hospital readmission of home and hospital groups of patients were evaluated.

Secondary outcomes

  1. Other outcomes evaluated included the duration of abdominal pain and time to resumption of an oral diet, both measured in hours from the time of presentation.

    Time frame: hours

    Elaboration time of abdominal pain in home and hospital group patients as hour from the admission time to ICU.

    Time to resumption of an oral diet measured from the time of presentation.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

A Randomized Controlled Trial of Home Monitoring Versus Hospitalization in Mild Non-Alcoholic Acute Interstitial Pancreatitis

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 22, 2013
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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