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.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||30 Days|
|Official Title:||A Randomized Controlled Trial of Home Monitoring Versus Hospitalization in Mild Non-Alcoholic Acute Interstitial Pancreatitis|
- The primary outcome of the study was the 30 day hospital readmission rate. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]30 day hospital readmission of home and hospital groups of patients were evaluated.
- 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 ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||November 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796652
|Bezmialem Vakıf University Hospital, Gastroenterology Clinic|
|İstanbul, Turkey, 34093|
|Principal Investigator:||Hakan Şentürk, Prof.||Bezmialem Vakıf University Hospital, Gastroenterology Clinic|