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
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFebruary 26, 2015
February 1, 2015
1 year
February 9, 2015
February 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Bowel function (as assessed by questionnaire)
Time to passage of flatus
Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)
Secondary Outcomes (4)
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)
Post op nausea and vomiting score (as recorded by visual analogue scale)
Recorded daily for first 5 days
Morbidity
Days (recorded up to 30 days and defined by Clavien-Dindo scale)
Study Arms (2)
Chewing gum
EXPERIMENTALPatients will chew sugar free gum three times a day
Control
NO INTERVENTIONNormal post operative care
Interventions
Eligibility Criteria
You may qualify if:
- Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent
You may not qualify if:
- Emergency colorectal surgery, unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Countess of Chester Hospital
Chester, Cheshire, CH2 1UL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dale Vimalachandran, MD FRCS
Countess of Chester
- PRINCIPAL INVESTIGATOR
Rachel Clifford, MRCS
Countess of Chester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Colorectal Surgeon
Study Record Dates
First Submitted
February 9, 2015
First Posted
February 26, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2016
Study Completion
October 1, 2016
Last Updated
February 26, 2015
Record last verified: 2015-02