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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02372500

Enrollment

130

Registered

2015-02-26

Start date

2015-03-31

Completion date

2016-10-31

Last updated

2015-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Surgery

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)

Interventions

DIETARY_SUPPLEMENTChewing gum

Sugar free chewing gum

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Emergency colorectal surgery, unable to consent

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)	—
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)
Morbidity	Days (recorded up to 30 days and defined by Clavien-Dindo scale)	Post operative morbidity

Countries

United Kingdom

Contacts

Primary ContactDale Vimalachandran, MD FRCS

dale.vimalachandran@nhs.net4401244365475

Backup ContactSheila Williams

sheila.williams4@nhs.net

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026