Acute pancreatitis accounts for a large number of hospital admissions every year. Some studies have shown that early oral feeding protocols are safe, and one previous study suggests the possibility of home care for mild acute pancreatitis.
Approximately 80% of all cases of acute pancreatitis are mild and only require supportive care for pain and nausea control and an adequate fluid replacement. Currently, all patients in our setting diagnosed with mild acute pancreatitis are admitted to a conventional hospitalization ward under the supervision of the Digestive and General Surgery Department or the Gastroenterology Department. Symptomatic treatment is administered, and abdominal ultrasound is performed to assess the cause of pancreatic inflammation. The remaining 20% fulfill the severity criteria from its onset onwards and require intensive care support. We will conduct a multicenter randomized controlled clinical trial to compare two different approaches to mild non-alcoholic acute pancreatitis: hospital admission and outpatient management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
308
In-patient care.
Early discharge and outpatient follow-up.
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITING7-day (after randomization) treatment failure rate
Treatment failure is defined as a VAS \>3 and/or oral feeding intolerance (nausea, repeated vomiting episodes, early satiety).
Time frame: 7 days
Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis
Complications include, but are not limited to, abscess formation, pseudocysts, local necrosis, kidney failure, respiratory failure.
Time frame: 30 days
Hospital readmission during the first 30 days after diagnosis
Number of patients readmitted to the hospital during the first 30 days after diagnosis.
Time frame: 30 days
Cumulative incidence of mortality during the first 30 days after diagnosis
30-day mortality
Time frame: 30 days
Estimated costs of each intervention
Time frame: 7 days
Median (95%CI) Charlson Comorbidity Score per group
Time frame: 7 days
Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score
Time frame: 7 days
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