Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery

Not Applicable

• Conditions: Colorectal Cancer; Surgery
• Interventions: Dietary Supplement: Chewing gum

• Registration Number: NCT02372500
• Lead Sponsor: Countess of Chester NHS Foundation Trust

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)

Study Timeline

• Status Verified: 2015-02
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-20
• Last Update Submitted: 2015-02-20
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26
• Study Start: 2015-03
• Primary Completion: 2016-03
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent

Exclusion Criteria

• Emergency colorectal surgery, unable to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chewing gum	Chewing gum	Patients will chew sugar free gum three times a day

Primary Outcome Measures

Name	Time	Method
Bowel function (as assessed by questionnaire)	Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)	Time to passage of flatus

Secondary Outcome Measures

Name	Time	Method
Diet (as assessed by questionnaire)	Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation)	Time to tolerating full diet
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 operative morbidity
Post op nausea and vomiting score (as recorded by visual analogue scale)	Recorded daily for first 5 days	Post op nausea and vomiting score (PONV)

Trial Locations

Locations (1)

Countess of Chester Hospital; 🇬🇧 Chester, Cheshire, United Kingdom