Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)

NCT ID: NCT01728896

Last Updated: 2019-09-26

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-01

Study Completion Date

2019-06-01

Brief Summary

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The first step in treating patients with acute pancreatitis is to provide pain relief and intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel better food and fluids by mouth are restarted. This is done to rest the pancreas which is the organ that has been inflamed.

In some patients when food by mouth restarts they have pain and as a consequence they have a longer stay in hospital. It is thought that patients who have little pain and are within 24 hours of admission to hospital do well if they control their own food intake. This is in contrast to the usual treatment where the treating team advise when eating should restart.

Detailed Description

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Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Study Groups

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Patient-controlled oral refeeding

Patients will be allowed to drink and eat hospital food freely as tolerated.

Group Type EXPERIMENTAL

Patient-controlled oral refeeding

Intervention Type OTHER

Conventional management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Patient-controlled oral refeeding

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of acute pancreatitis
* age \> 18 years
* written informed consent

Exclusion Criteria

* ongoing need for opiates
* \>96 hours after onset of symptoms
* chronic pancreatitis
* post-ERCP pancreatitis
* intraoperative diagnosis
* pregnancy
* malignancy
* received nutrition before randomisation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Auckland, New Zealand

OTHER

Sponsor Role lead

Responsible Party

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Max Petrov

Prinicpal Investigator Dr. Max Petrov

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Auckland; Auckland City Hospital

Auckland, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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NTX/12/06/051

Identifier Type: -

Identifier Source: org_study_id

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