Ensayo clinico multicentrico, prospectivo aleatorizado, que compara la eficacia de inicio de dieta oral temprana frente a dieta absoluta en pacientes con pancreatitis aguda

Identificador:  TDX:3056

Handle: https://hdl.handle.net/20.500.11797/TDX3056

Autors:  Ramírez Maldonado, Ruby Elena

Resum:
INTRODUCTION: Nutritional support for patients with acute pancreatitis is essential. The greatest benefits are obtained if the diet is started early, but the definition of early term is controversial. The aim of this study is to establish the optimal time to start the diet in order to achieve a reduction in hospital stay and complications. METHODS: Multi-center, randomized, controlled study. We included patients with a diagnosis of acute pancreatitis, who were admitted consecutively to 4 hospitals from 2017 to 2019. They were randomized in two treatment branches: a group with conventional oral refeeding (CORF) and another group with early oral refeeding (EORF). The EORF group (solid diet was initiated immediately after hospital admission) was compared with CORF group (that restarted progressive oral diet when clinical and laboratory symptoms had improved). Hospital stay, relapse pain, complications, quality of life (QoL) and costs were compared between the two groups. RESULTS: A total of 131 patients were randomized. The mean hospital stay for CORF and EORF group was 8.8 (SD±7.9) days and 3.4 (SD±1.7) days respectively (p<0.001). Pain relapse was 16% only in the CORF group. Complications were more in CORF vs EORF group (26% vs 8%). The health cost was 1.6 times lower in the EORF group, with savings of 837.4€ per patient. CONCLUSIONS: The EORF in patients with mild and moderate acute pancreatitis is safe and feasible, improving hospital stay without adverse effects, without affecting QoL and with significant cost savings. Registered at www.clinicaltrials.gov (NCT03829085).