Randomised Controlled Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Countess of Chester NHS Foundation Trust
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Bowel function (as assessed by questionnaire)
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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)
Investigators
Dale Vimalachandran
Consultant Colorectal Surgeon
Countess of Chester NHS Foundation Trust
Eligibility Criteria
Inclusion Criteria
- •Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent
Exclusion Criteria
- •Emergency colorectal surgery, unable to consent
Outcomes
Primary Outcomes
Bowel function (as assessed by questionnaire)
Time Frame: Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)
Time to passage of flatus
Secondary Outcomes
- Diet (as assessed by questionnaire)(Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation))
- Length of stay(Days (till successful discharge from secondary care to home or respite care measured up to first 31 days))
- Morbidity(Days (recorded up to 30 days and defined by Clavien-Dindo scale))
- Post op nausea and vomiting score (as recorded by visual analogue scale)(Recorded daily for first 5 days)