CClinicalTrials.gg
Status unknownNCT02372500Updated Feb 26, 2015

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

An interventional study of Chewing gum in Colorectal Cancer and Surgery, sponsored by Countess of Chester NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-26.

Sponsored by Countess of Chester NHS Foundation Trust · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Colorectal Cancer
  • Surgery
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 130 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Countess of Chester NHS Foundation Trust is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Emergency colorectal surgery, unable to consent
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Chewing gum

    Patients will chew sugar free gum three times a day

    Dietary Supplement: Chewing gum

  • No intervention
    Control

    Normal post operative care

Interventions

  • Dietary supplementChewing gum

    Sugar free chewing gum

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Length of stay

    Time frame: Days (till successful discharge from secondary care to home or respite care measured up to first 31 days)

  3. 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

  4. Morbidity

    Post operative morbidity

    Time frame: Days (recorded up to 30 days and defined by Clavien-Dindo scale)

07

Study locations

1 site
  • Countess of Chester Hospital
    Chester, Cheshire CH2 1UL, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02372500
Lead sponsor
Countess of Chester NHS Foundation Trust
Responsible party
Dale Vimalachandran (Consultant Colorectal Surgeon, Countess of Chester NHS Foundation Trust) — Principal investigator
First posted
Feb 26, 2015
Start date
Mar 2015
Primary completion
Mar 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
Feb 26, 2015

Study contacts

Dale Vimalachandran, MD FRCS
Contact
dale.vimalachandran@nhs.net
4401244365475
Sheila Williams
Contact
sheila.williams4@nhs.net
Dale Vimalachandran, MD FRCS
study director · Countess of Chester
Rachel Clifford, MRCS
principal investigator · Countess of Chester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion