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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01128478




Registration number
NCT01128478
Ethics application status
Date submitted
11/05/2010
Date registered
24/05/2010
Date last updated
8/01/2013

Titles & IDs
Public title
MIld to MOderate Acute Pancreatitis: Early naSogastric Tube Feeding Compared With pAncreas Rest (MIMOSA)
Scientific title
Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial
Secondary ID [1] 0 0
NTX/08/11/107
Universal Trial Number (UTN)
Trial acronym
MIMOSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Pancreatitis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Enteral tube feeding

Other: Enteral tube feeding - Nasogastric tube feeding started within 24 h of hospital admission

No intervention: Nil-per-mouth regimen - Conventional management


Treatment: Surgery: Enteral tube feeding
Nasogastric tube feeding started within 24 h of hospital admission
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Length of hospital stay
Timepoint [1] 0 0
Up to 3 months
Secondary outcome [1] 0 0
Pain relapse
Timepoint [1] 0 0
Up to 3 months
Secondary outcome [2] 0 0
Local and systemic complications
Timepoint [2] 0 0
Up to 3 months
Secondary outcome [3] 0 0
Feeding intolerance
Timepoint [3] 0 0
Up to 3 months
Secondary outcome [4] 0 0
Time to solid oral food tolerated
Timepoint [4] 0 0
Approx. one week
Secondary outcome [5] 0 0
Pain-free time
Timepoint [5] 0 0
Up to 3 months
Secondary outcome [6] 0 0
Hospital readmission
Timepoint [6] 0 0
Up to 6 months
Secondary outcome [7] 0 0
Quality of life
Timepoint [7] 0 0
Up to 6 months
Secondary outcome [8] 0 0
Mortality
Timepoint [8] 0 0
Up to 6 months

Eligibility
Key inclusion criteria
* diagnosis of acute pancreatitis
* age 18 years or older
* written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* > 96 hours after onset of symptoms
* > 24 hours after hospital admission
* organ failure by the time of randomization
* infectious complications before randomization
* received artificial nutrition before randomization
* previously enrolled into the trial
* chronic pancreatitis
* post-ERCP pancreatitis
* intraoperative diagnosis of acute pancreatitis
* pregnancy
* malignancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Max Petrov, MD, MPH (Epi)
Address 0 0
Universioty of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01128478