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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01648972




Registration number
NCT01648972
Ethics application status
Date submitted
24/07/2012
Date registered
25/07/2012
Date last updated
4/07/2014

Titles & IDs
Public title
Gastrografin in Postoperative Ileus
Scientific title
Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.
Secondary ID [1] 0 0
UOA-ggRCT1
Universal Trial Number (UTN)
Trial acronym
GAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged Postoperative Ileus 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gastrografin
Treatment: Drugs - Placebo

Experimental: Gastrografin -

Placebo Comparator: Placebo -


Treatment: Drugs: Gastrografin


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Length of hospital stay (days)
Timepoint [1] 0 0
Days

Eligibility
Key inclusion criteria
- Age > 18 years.

- Current inpatient following elective laparoscopic or open surgery.

- Classified as having prolonged postoperative ileus.

- Able to understand risks/benefits of the study.

- Able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy.

- ASA of 4 or greater.

- Previous allergic reaction to gastrografin or iodinated contrast agents.

- Manifest hyperthyroidism.

Study design
Purpose of the study
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2/Phase 3
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
1/09/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
AKL

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

Ethics approval
Ethics application status

Summary
Brief summary
After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this
time patients are often unable to eat and drink, and do not pass any flatus or stool. Though
this resolves within a few days for most, there are a significant number (around 30%) who go
on to have a prolonged period of this dysfunction known clinically as postoperative ileus. It
has been clearly shown that this group of patients have worse health outcomes and spend a
longer time in hospital.

The aim of this study is to trial a drug - gastrografin - in the management of prolonged
postoperative ileus. Gastrografin is safe, economical, readily available, and has been used
with great success in the similar condition of bowel obstruction. It is predicted that
gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording
affected patients a better outcome from surgery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01648972
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01648972