Evidence map›Paper›PMID 32677891›Full record

Trial reportBMC gastroenterology2020

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

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in BMC gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04168801 (Non-inferiority Comparative Clinical Trial Between Early Oral Refeeding Versus Usual Oral Refeeding in Mild Acute Pancreatitis Patients), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04168801 nacompletednot on this map

Non-inferiority Comparative Clinical Trial Between Early Oral Refeeding Versus Usual Oral Refeeding in Mild Acute Pancreatitis Patients

TypeinterventionalSponsorHospital Regional de Alta Especialidad del BajioRan2018 to 2019Enrolled124ConditionsPancreatitisArmsearly oral refeeding
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Edgard Efrén Lozada-HernándezDepartment of Surgery and Clinical Research, Hospital Regional de Alta Especialidad del Bajío, Circuito Quinta los Naranjos # 145 B. Colonia Quinta los Naranjos, León, Guanajuato, Mexico. edgardlozada@hotmail.com.ORCID http://orcid.org/0000-0001-8614-9516
Omar Barrón-GonzálezDepartment of Surgery, Unidad Médica de Alta Especialidad Bajío, Instituto Mexicano del Seguro Social, León, Guanajuato, Mexico.
Santa Vázquez-RomeroDepartment of Surgery, Unidad Médica de Alta Especialidad Bajío, Instituto Mexicano del Seguro Social, León, Guanajuato, Mexico.
Martin Cano-RosasDepartment of Surgery, Unidad Médica de Alta Especialidad Bajío, Instituto Mexicano del Seguro Social, León, Guanajuato, Mexico.
Evelia Apolinar-JimenezDepartment of Clinical Nutrition, Hospital Regional de Alta Especialidad del Bajío, León, Guanajuato, Mexico.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsThis 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.

resultsTwo 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).

conclusionCompared 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 registrationEarly oral refeeding in mild acute pancreatitis (EORVsUOR). NCT04168801 , retrospectively registered (November 19, 2019).

Indexed as

PancreatitisAbdominal PainAcute DiseaseHumansProspective StudiesRecurrenceMild acute biliary pancreatitisNil per osNon-inferiority clinical trialOral feeding

Identifiers

PMID32677891
PMCPMC7364543

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.