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Trial registered on ANZCTR


Registration number
ACTRN12615000430538
Ethics application status
Approved
Date submitted
21/04/2015
Date registered
6/05/2015
Date last updated
10/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Gum Chewing on Postoperative Recovery of Gut Function:
A Randomised Controlled Trial
Scientific title
In early postoperative patients who had undergone elective bowel resection, does chewing sugar-free gum for 15 minutes 4 times a day, reduce the duration of ileus, improve patient experience and reduce length of hospital stay.
Secondary ID [1] 286549 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative ileus 294795 0
Condition category
Condition code
Surgery 295070 295070 0 0
Other surgery
Oral and Gastrointestinal 295071 295071 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Duration of treatment: The treatment commenced as soon a practicable following bowel surgery which was usually when they were admitted to the colorectal ward. Participants in the chewing gum group were asked to chew gum for 15 minutes, four times a day, for up to 14 days following their operation, or until a normal bowel motion had occurred and the participant was able to tolerate a normal full diet for 24 hours, whichever occurred earlier.

Strategies to monitor adherence to the intervention: Chewing gum was prescribed on the patient’s medication chart and administered by nurses as any other tablet or intravenous medication.
Intervention code [1] 291655 0
Treatment: Other
Comparator / control treatment
Both study groups received the same postoperative care. In general, patients were permitted sips of fluids on the day of surgery. They were progressed to a fluid diet the following day and depending on their progress and the instruction of their treating surgeon. Postoperatively patients were commenced on intravenous fentanyl or morphine patient controlled analgesia, in addition to regular intravenous or oral paracetamol. When tolerating oral intake, patients were transferred to oxycodone or codeine.
Control group
Active

Outcomes
Primary outcome [1] 294835 0
Primary Outcome 1: time to discharge (length of stay [LOS])
Timepoint [1] 294835 0
The "Length of Stay" was measured in hours from the start time of surgery until the time of hospital discharge.
Primary outcome [2] 294862 0
Primary Outcome 2: time to first flatus

Method of Assessment: A treating nurse completed a paper based CRF (case report form) until the patient was discharged from hospital or until a normal bowel motion had occurred and they were able to tolerate a normal full diet for 24hrs, whichever occurs earlier. This CRF recorded the patients’ time to passing first flatus, time to passing first bowel motion, as well as daily documentation of the patients reported pain score and their daily medications. This data was reported or observed by the patients and recorded by the treating nurse.
Timepoint [2] 294862 0
This timepoint was measured in hours from the start time of surgery until the time of first flatus.
Primary outcome [3] 294863 0
Primary outcome 3: time to first bowel motion

Method of Assessment: A treating nurse completed a paper based CRF (case report form) until the patient was discharged from hospital or until a normal bowel motion had occurred and they were able to tolerate a normal full diet for 24hrs, whichever occurs earlier. This CRF recorded the patients’ time to passing first flatus, time to passing first bowel motion, as well as daily documentation of the patients reported pain score and their daily medications. This data was reported or observed by the patients and recorded by the treating nurse.
Timepoint [3] 294863 0
This timepoint was measured in hours from the start time of surgery until the time of first bowel motion (faeces).
Secondary outcome [1] 314238 0
Secondary Outcome 1: complications rates

Intra-operative complications:
Adverse anaesthetic event
Haemorrhage
Minor injury to small intestine or colon
Major injury to small intestine or colon
Ureteric injury
Duodenal injury
Gas embolus
Pneumothorax
Hypercarbial / acidosis

Early post-operative complications:
Pyrexia
Prolonged ileus
Recurrent ileus
Pulmonary retention
Urinary retention
UTI (urinary tract infection)
Wound infection
Abdominal sepsis
Anastomotic leak
Haemorrhage
Reoperation
Anaesthetic complication
Medical complication
ICU

NG tube:
Intra-op
Post-op
Re-insertion
Timepoint [1] 314238 0
The patient's medical records were reviewed by the study co-ordinator at the time of discharge and the type of complication is recorded on a data collection sheet to calculate the rate of complications in both groups, that is, the chewing gum group and non-chewing gum group.
Secondary outcome [2] 314239 0
Secondary outcome 2: pain

Method of Assessment: A treating nurse completed a paper based CRF (case report form) until the patient was discharged from hospital or until a normal bowel motion had occurred and they were able to tolerate a normal full diet for 24hrs, whichever occurs earlier.

This CRF recorded the patients’ reported pain score, 0-10, where 10 was the worst pain. This data was reported by the patient verbally and recorded by the treating nurse.
Timepoint [2] 314239 0
Daily until the patient was discharged from hospital or until a normal bowel motion had occurred and they were able to tolerate a normal full diet for 24hrs, whichever occurs earlier.
Secondary outcome [3] 314240 0
Secondary outcome 3: total morphine equivalent

The patient's medical records were reviewed by the study co-ordinator at the time of discharge. Medications together with dosage were recorded on a data collection sheet to calculate the daily total medication morphine equivalents given to patients in both the chewing gum group and non-chewing gum group.
Timepoint [3] 314240 0
Up to and including 7 days post-operation.

Eligibility
Key inclusion criteria
All adult patients from Royal Prince Alfred Hospital in Sydney undergoing elective open abdominal or pelvic surgery involving bowel resection.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known swallowing difficulties
Risk of aspiration
Planned stoma
Cognitive impairment
Unable to give informed consent
English illiterate

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)
Initial contact with the patient was made by the consulting surgeon and after informed consent was given, patients were randomly allocated to one of two treatment groups, a ‘chewing gum group’ or a ‘non-chewing gum group’. Randomisation was done by the study coordinator using a chart of randomised numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence, sealed envelopes with treatment allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The hypothesis for this study was that chewing gum reduces time to discharge, time to first flatus and time to first bowel motion.

Statistical Analysis
Statistical analysis was conducted using SPSS 20.0 (IBM, USA). Patients were analysed in the study group to which they were randomised in accordance with intention to treat principles. The level of significance for all tests was set to p < 0.05. Comparisons between study groups were analysed using the independent T-test for continuous data that were normally distributed and appropriate non parametric tests (Mann-Whitney U) for skewed data. Categorical data was analysed using a combination of Chi-square tests and Fisher’s exact tests (FET). Mean and medians are reported alongside the standard deviation (SD), inter quartile range (IQR) or 95% confidence intervals (CI) where appropriate.

Kaplan-Meier and Cox Regression analysis was used to describe time to event data. Length of stay was measured in hours from the start time of surgery until the time of discharge. Flatus and bowel follow up times were measured in hours from the time the procedure ended to the time of the event, or the time of last follow up (time of discharge) if the event did not occur. The Log-rank test was used to determine statistical significance between curves. Survival is reported alongside a standard error (SE). Adjustment was made for any procedure detail that was considered to be strong clinical predictor of the outcome (surgery type).

Sample size
A total sample size of 162 participants (81 in each arm) was calculated. This represented the minimum number required based on the average length of post-operative stay being 5 days and a clinically meaningful reduction determined as a minimum of 2 days. Power was set at 90% with a 5% significance level. The PS (Power and Sample size) program was utilised to derive this sample size estimation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3719 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 9542 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 291134 0
Hospital
Name [1] 291134 0
Royal Prince Alfred Hospital
- Colorectal Department
Address [1] 291134 0
Missenden Road
Camperdown NSW 2050
Country [1] 291134 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 289814 0
None
Name [1] 289814 0
Address [1] 289814 0
Country [1] 289814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292711 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 292711 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 292711 0
Australia
Date submitted for ethics approval [1] 292711 0
Approval date [1] 292711 0
10/11/2009
Ethics approval number [1] 292711 0
HREC/09/RPAH/564

Summary
Brief summary
Postoperative ileus (gut stasis) is a common event seen in patients following major surgery involving bowel resection, contributing to significant postoperative morbidity including delayed resumption of nutritional feeding, patient discomfort, prolonged hospitalisation and increased healthcare cost. The economic impact of postoperative ileus in patients following colectomy is estimated at approximately 1 billion US dollars per year in the United States alone (1). Current management is largely supportive with no widely accepted treatment found to be effective in reducing the period of ileus in postoperative patients.

Given the scale of potential benefit, the main aim was to conduct a well-constructed trial involving an adequate number of patients to determine whether gum chewing in the early postoperative period does help to reduce duration of ileus, improve patient experience and decrease length of hospital stay.

Reference (1): Schuster R, Grewal N, et al. Gum Chewing Reduces Ileus After Elective Open Sigmoid Colectomy. Arch Surg. 2006 Feb; 141(2): 174-6

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56610 0
A/Prof Chris Byrne
Address 56610 0
Royal Prince Alfred Hospital,
Colorectal Research Department,
Missenden Road,
Camperdown NSW 2050
Country 56610 0
Australia
Phone 56610 0
+61, 2, 9519 7576
Fax 56610 0
+61, 2, 9519 1806
Email 56610 0
chrismbyrne@hotmail.com
Contact person for public queries
Name 56611 0
A/Prof Chris Byrne
Address 56611 0
Royal Prince Alfred Hospital,
Colorectal Research Department,
Missenden Road,
Camperdown NSW 2050
Country 56611 0
Australia
Phone 56611 0
+61, 2, 9519 7576
Fax 56611 0
+61, 2, 9519 1806
Email 56611 0
chrismbyrne@hotmail.com
Contact person for scientific queries
Name 56612 0
A/Prof Chris Byrne
Address 56612 0
Royal Prince Alfred Hospital,
Colorectal Research Department,
Missenden Road,
Camperdown NSW 2050
Country 56612 0
Australia
Phone 56612 0
+61, 2, 9519 7576
Fax 56612 0
+61, 2, 9519 1806
Email 56612 0
chrismbyrne@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary