Non-inferiority comparative clinical trial between early oral REFEEDING and usual oral REFEEDING in predicted mild acute biliary pancreatitis

Edgard Efrén Lozada-Hernández, Omar Barrón-González, Santa Vázquez-Romero, Martin Cano-Rosas, Evelia Apolinar-Jimenez, Edgard Efrén Lozada-Hernández, Omar Barrón-González, Santa Vázquez-Romero, Martin Cano-Rosas, Evelia Apolinar-Jimenez

Abstract

Background: The aim of the study was to compare the onset of oral feeding in the first 24 h after hospital admission with usual oral refeeding and determine whether the timing of the onset of oral feeding influences the recurrence of pain or alters the blood levels of pancreatic enzymes in patients with predicted mild acute biliary pancreatitis.

Methods: This non-inferiority randomized controlled trial was carried out between September 2018 and June 2019 after receiving authorization from the ethics committee for health research. Patients with a diagnosis of predicted mild acute biliary pancreatitis were divided into Group A (early oral refeeding, EOR) and Group B (usual oral refeeding, UOR). Outcome measures included pancreatic lipase levels, the systemic inflammatory response (concentrations of leukocytes), feasibility (evaluated by abdominal pain recurrence), the presence and recurrence of gastrointestinal symptoms and the length of hospital stay.

Results: Two patients in the EOR group experienced pain relapse (3.2%), and four patients in the UOR group experienced pain relapse (6.77%) after oral refeeding (p = 0.379). The presence of nausea or vomiting after the onset of oral refeeding was not different between the two groups (p = 0.293). The onset of oral refeeding was approximately 48 h later in the UOR group. The length of hospital stay was 5 days in the EOR group and 8 days in the UOR group (p = 0.042), and this difference was also manifested in higher hospital costs in the UOR group (p = 0.0235).

Conclusion: Compared with usual oral refeeding, early oral refeeding is safe in predicted mild acute biliary pancreatitis patients, does not cause adverse gastrointestinal events, and reduces the length of hospital stay and costs.

Trial registration: Early oral refeeding in mild acute pancreatitis (EORVsUOR). NCT04168801 , retrospectively registered (November 19, 2019).

Keywords: Mild acute biliary pancreatitis; Nil per os; Non-inferiority clinical trial; Oral feeding.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

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Fig. 1
CONSORT flow diagram

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