Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000538448
Ethics application status
Approved
Date submitted
16/10/2007
Date registered
22/10/2007
Date last updated
3/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Gum-chewing on Postoperative Recovery of Gut Functions: A Randomised Controlled Clinical Trial
Scientific title
In adults following surgery involving gastric or bowel resection, with or without primary anastomosis, does the addition of regular gum-chewing in the immediate postoperative period compared to standard postoperative care alone reduce recovery time and length of hospital stay?
Secondary ID [1] 285435 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative ileus 2466 0
Condition category
Condition code
Surgery 2566 2566 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Commercially available sugar-free chewing gum in peppermint flavour. One piece is administered four times a day and the participants in the treatment arm are asked to chew the gum for 15minutes each time. Treatment is commenced as soon as practicable following the surgery (usually on admission to ward) and continue until post-operative day 14 or discharge, whichever occurs earlier.
Intervention code [1] 2195 0
Treatment: Other
Comparator / control treatment
standard postoperative care which includes being kept nil by mouth on the day of the operation and high protein-high energy fluids are commenced on postoperative day 1. High-protein-high-energy fluid is continued until post-operative day 2 and if tolerated, solids are commenced on day 3. Postoperative analgesia are determined by patient needs and may include parenteral or enteral narcotics if required.
Control group
Active

Outcomes
Primary outcome [1] 3470 0
Time to first bowel motion
Timepoint [1] 3470 0
daily until the first bowel motion or 14 days have elapsed, whichever occurs first.
Primary outcome [2] 3471 0
time to tolerance of normal diet
Timepoint [2] 3471 0
from post-operative day 3 until discharge or 14 days have elapsed, whichever occurs first.
Primary outcome [3] 3472 0
Length of stay
Timepoint [3] 3472 0
at discharge
Secondary outcome [1] 5790 0
Pain score on a visual analogue scale
Timepoint [1] 5790 0
daily until 14 days have elapsed or dishcarge from hospital, whichever occurs first
Secondary outcome [2] 5791 0
Incidence of symptoms of ileus including nausea, vomiting and bloating
Timepoint [2] 5791 0
daily until 14 days have elapsed or dishcarge from hospital, whichever occurs first
Secondary outcome [3] 5792 0
Incidence of postoperative complications including prolonged ileus requiring nasogastric tube insertion, wound dehiscence, readmission to intensive care unit, unplanned readmission within 30 days
Timepoint [3] 5792 0
during trial and at 30 days post-discharge

Eligibility
Key inclusion criteria
Elective surgery involving any form of gastric or bowel resection with or without primary anastomosis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with known risk of aspiration eg. cognitively or intellectually impaired, previous stroke with residual neurological deficiency involving the facial-oro-pharyngeal muscles. Patients who require prolonged intubation/sedation immediately post-op.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potentially suitable patients are identified from the hospital's elective operation list 3-4 days prior to the planned operation. Patients are invited to participate in the study on the day of their operation at the time of admission. Medical records review and physical examination of the patients are performed to ensure patient meet the eligibility criteria and none of the exclusion criteria. Patient information is given and informed consent is obtained. Once the patient has consented, the trial secretary is contacted to obtain the randomisation sequence and the patient is allocated into the arms of the study accordingly. The randomisation sequence is stored in the locked office of one of the main investigators who is not involved in the process of subject recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study subjects are stratified into 3 groups of equal sizes and a computer generated sequence of random numbers are produced. The overall balance between treatment and control within each stratum is checked for approximately even distribution.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/09/2007
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
31/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 285 0
2305

Funding & Sponsors
Funding source category [1] 2709 0
Self funded/Unfunded
Name [1] 2709 0
Dr Stephen Smith
Country [1] 2709 0
Australia
Primary sponsor type
Hospital
Name
Division of Surgery, John Hunter Hospital
Address
Lookout Road, New Lambton Heights, 2305, NSW
Country
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4631 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 4631 0
Ethics committee country [1] 4631 0
Australia
Date submitted for ethics approval [1] 4631 0
Approval date [1] 4631 0
02/07/2007
Ethics approval number [1] 4631 0
07/06/20/5.01

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

Contacts
Principal investigator
Name 28120 0
Dr Stephen Smith
Address 28120 0
Division of Surgery, John Hunter Hospital Lookout Road, New Lambton Heights, NSW, 2305
Country 28120 0
Australia
Phone 28120 0
+61 2 49563243
Fax 28120 0
Email 28120 0
[email protected]
Contact person for public queries
Name 11277 0
Stephen Smith
Address 11277 0
Division of Surgery, John Hunter Hospital
Lookout Road, New Lambton Heights, NSW, 2305
Country 11277 0
Australia
Phone 11277 0
+61 2 49563243
Fax 11277 0
+61 2 49563246
Email 11277 0
[email protected]
Contact person for scientific queries
Name 2205 0
Stephen Smith
Address 2205 0
Division of Surgery, John Hunter Hospital
Lookout Road, New Labmton Heights, NSW, 2305
Country 2205 0
Australia
Phone 2205 0
+61 2 49563243
Fax 2205 0
+61 2 49563246
Email 2205 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.