It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus.
Patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care. The primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes). The trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
130
Sugar free chewing gum
Countess of Chester Hospital
Chester, Cheshire, United Kingdom
Bowel function (as assessed by questionnaire)
Time to passage of flatus
Time frame: Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)
Diet (as assessed by questionnaire)
Time to tolerating full diet
Time frame: Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation)
Length of stay
Time frame: Days (till successful discharge from secondary care to home or respite care measured up to first 31 days)
Post op nausea and vomiting score (as recorded by visual analogue scale)
Post op nausea and vomiting score (PONV)
Time frame: Recorded daily for first 5 days
Morbidity
Post operative morbidity
Time frame: Days (recorded up to 30 days and defined by Clavien-Dindo scale)
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