MedDataX Logo

Inmediate Feeding Tolerance in Acute Pancreatitis

NCT ID: NCT03354065

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Objective: Determine tolerance of immediate oral intake (8 hours posterior to the beginning of treatment) against traditional management (early feeding at 48hr) in patients with mild acute pancreatitis of biliary origin.

Double blind, randomized clinical trial

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators included patients 15 - 85 years old, any sex. Diagnosis of mild acute pancreatitis according to the Ranson, APACHE II and BISAP.

Signed infromed consent to participate in the study. All participants had a hepatic and biliary ultrasound to determine the biliary etiology.

The investigators excluded patients with pancreatitis of nonbiliary etiology, pregnant, severe pancreatitis, cholangitis or choledocholithiasis demonstrated during the hospital stay or with other comorbidities.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Pancreatitis Due to Gallstones

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pancreatitis mild biliary referring

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
blinding of the evaluator to the study group blinding of patient to study hypothesis

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early oral feeding

TIME OF FEEDING. 48 hours after pancreatitis general management is started ( liquid diet)

Group Type ACTIVE_COMPARATOR

TIME OF FEEDING

Intervention Type DIETARY_SUPPLEMENT

Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)

Immediate oral feeding

TIME OF FEEDING: 8 hours of after pancreatitis general management is started (enteral formula)

Group Type EXPERIMENTAL

TIME OF FEEDING

Intervention Type DIETARY_SUPPLEMENT

Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TIME OF FEEDING

Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients older than 15 years.

* Patients with a diagnosis of mild acute pancreatitis biliary.
* Patients who agree to enter the protocol.

Exclusion Criteria

* Patients managed at another institution.

* Patients with a diagnosis of pancreatitis of non-biliary etiology.
* Patients with heart disease or lung disease.
* Patients with organic failure.
* Patients with pregnancy.
* Patients with cholangitis.
Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Central "Dr. Ignacio Morones Prieto"

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Esmer

head of the surgery service of Central Hospital, SLP, Mex

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juan F Hernandez

Role: STUDY_CHAIR

Postgraduate office at UASLP

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07-15

Identifier Type: -

Identifier Source: org_study_id