CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 124 enrolled
Drug / intervention
early oral refeedingdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04168801
NCT04168801N/ACompleted

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

Hospital Regional de Alta Especialidad del Bajio·interventional·Posted Nov 19, 2019·Updated Nov 19, 2019

In Brief

A clinical study evaluating early oral refeeding for Pancreatitis. Completed, enrolled 124 participants across 1 site.

Detailed Summary

Background The aim of the study is to compare the onset of oral feeding in the first 24 hours after hospital admission and determine if this influences the recurrence of pain or alters the blood levels of pancreatic enzymes, compared to usual oral refeeding in patients with mild acute pancreatitis Methods This Non-Inferiority Randomized controlled trial was carried out between September 2018 and June 2019, prior authorization from the ethics committee in health research. Patients with diagnosis of mild acute biliary pancreatitis, were divided into: Group A (early oral refeeding) and Group B (usual oral refeeding). Outcome measures were lipase pancreatic, systemic inflammatory response (concentrations of leukocytes) were used as marker for it, feasibility evaluated by abdominal pain recurrence, presence and recurrence of gastrointestinal symptoms and length of hospital stay. The aim of the present study is to compare the onset of oral feeding in the first 24 hours after hospital admission and determine if this influences the recurrence of pain or alters the blood levels of pancreatic enzymes, compared to usual oral refeeding in patients with mild acute pancreatitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatitis
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 19, 2019
Enrollment StartSep 1, 2018
Primary CompletionJun 1, 2019
Study CompletionJun 20, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.6 years ago

Interventions

early oral refeedingdietary

Once the patient had a score of 1-3 of the analogue numerical scale (ENA), he was interrogated about symptoms such as nausea or vomiting, receives diet indicated between 16 and 24 hours after admission.