Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611001277932
Ethics application status
Approved
Date submitted
10/12/2011
Date registered
13/12/2011
Date last updated
13/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Does chewing gum help recovery after abdominal surgery?
Scientific title
In patients undergoing elective open abdominal surgery, does chewing gum reduce postoperative complications compared to standard postoperative care?
Secondary ID [1] 273591 0
Nil
Universal Trial Number (UTN)
U1111-1121-9467
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain, nausea and ileus. 279350 0
Condition category
Condition code
Oral and Gastrointestinal 279536 279536 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
Chewing gum (single piece of sugar-free) three times a day (breakfast, lunch, dinner) for at least thirty minutes from the first mealtime postoperatively until discharge. Time to discharge will vary between patients. Patients are normally discharged once they are opening their bowels adequately, are managing a light diet, their pain is manageable with oral anlgesia, they are mobilising adequately to be safe at home, are able to manage their colostomy if applicable, there are no other complications from surgery.
Intervention code [1] 283878 0
Treatment: Other
Comparator / control treatment
Standard postoperative management. This usually includes early (day 1 postop) and ongoing mobilisation, sips only of water until flatus then light diet as tolerated, analgesia as required, antiemetics as required, indwelling urinary catheter out as soon as mobilising, supportive intravenous fluids until sufficient fluid intake, bulking laxatives or codeine depending on bowel motion consistency, stoma nurse training if applicable, thromboprophylaxis, treatment of complications eg pneumonia, urinary tract infections, maintaining euvolaemia, wound care.
Control group
Active

Outcomes
Primary outcome [1] 286120 0
Time from surgery to flatus (hours).
Nursing staff each shift to ask patient about whether they have passed flatus.
Timepoint [1] 286120 0
Upon occurrence of flatus
Primary outcome [2] 286121 0
Time from surgery to bowel motion (hours).
Nursing staff each shift to ask patient about whether they have passed a bowel motion.
Timepoint [2] 286121 0
Upon occurence of bowel motion
Secondary outcome [1] 295185 0
Nausea score out of 10, 0 no nausea, 10 worst nausea ever imagined
Timepoint [1] 295185 0
Daily until discharge.
Secondary outcome [2] 295186 0
Pain score out of 10, 0 no pain, 10 worst pain ever imagined
Timepoint [2] 295186 0
Daily until discharge.

Eligibility
Key inclusion criteria
Elective open abdominal surgery, able to chew gum safely, under a surgeon who has agreed for their patients to be involved in this trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Transfer to another hospital, unable to give written consent

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)
Patients identified and approached at preadmission clinic by preadmission nurses. The participant chooses an opaque sealed envelope with a number in it, either 1 or 2.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the choosing of an opaque sealed envelope with 1 or 2 denoting group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 3998 0
New Zealand
State/province [1] 3998 0

Funding & Sponsors
Funding source category [1] 284358 0
Hospital
Name [1] 284358 0
Wairau Hospital - Nelson Marlborough District Health Board
Country [1] 284358 0
New Zealand
Funding source category [2] 284359 0
Commercial sector/Industry
Name [2] 284359 0
Terrace Distributors (1985) Ltd
Country [2] 284359 0
New Zealand
Primary sponsor type
Individual
Name
Dr Katherine Hulme
Address
Wairau Hospital,
Hospital Rd,
Blenheim, 7201
South Island
Country
New Zealand
Secondary sponsor category [1] 283299 0
Individual
Name [1] 283299 0
Dr Jeremy Stevens
Address [1] 283299 0
Wairau Hospital,
Hospital Rd,
Blenheim, 7201
South Island
Country [1] 283299 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286318 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 286318 0
6 Hazeldean Rd, Level 1 Montgomery Watson Building,
Addington,
Christchurch, 8024
South Island
Ethics committee country [1] 286318 0
New Zealand
Date submitted for ethics approval [1] 286318 0
14/11/2011
Approval date [1] 286318 0
05/12/2011
Ethics approval number [1] 286318 0
URB/11/11/042

Summary
Brief summary
There is some international evidence that chewing gum after abdominal surgery reduces postoperative pain and nausea, as well as reducing a complication of surgery called ileus. Ileus is a condition where the bowel (intestines) goes on ‘strike’ for a short time. While the bowel is in ileus you cannot eat or drink and are reliant on intravenous care in hospital. Ileus resolves without specific treatment but can take days or weeks and can cause secondary problems. Chewing gum may help reduce ileus by stimulating the bowel through a mechanism called the gastrocephalic reflex, though it is not fully understood. Results internationally are varied and may not be applicable to New Zealand as postoperative management is different in different countries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33509 0
Address 33509 0
Country 33509 0
Phone 33509 0
Fax 33509 0
Email 33509 0
Contact person for public queries
Name 16756 0
Dr Katherine Hulme
Address 16756 0
Wairau Hospital,
Hospital Rd,
Blenheim, 7201
South Island
Country 16756 0
New Zealand
Phone 16756 0
00 64 272201244
Fax 16756 0
Email 16756 0
[email protected]
Contact person for scientific queries
Name 7684 0
Dr Katherine Hulme
Address 7684 0
Wairau Hospital,
Hospital Rd,
Blenheim, 7201
South Island
Country 7684 0
New Zealand
Phone 7684 0
00 64 272201244
Fax 7684 0
Email 7684 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.