Back to resultsTrial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
Primary Purpose
Colorectal Cancer, Surgery
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Chewing gum
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent
Exclusion Criteria:
- Emergency colorectal surgery, unable to consent
Sites / Locations
- Countess of Chester Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chewing gum
Control
Arm Description
Patients will chew sugar free gum three times a day
Normal post operative care
Outcomes
Primary Outcome Measures
Bowel function (as assessed by questionnaire)
Time to passage of flatus
Secondary Outcome Measures
Diet (as assessed by questionnaire)
Time to tolerating full diet
Length of stay
Post op nausea and vomiting score (as recorded by visual analogue scale)
Post op nausea and vomiting score (PONV)
Morbidity
Post operative morbidity
Full Information
NCT ID
NCT02372500
First Posted
February 9, 2015
Last Updated
February 20, 2015
Sponsor
Countess of Chester NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02372500
Brief Title
Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
Official Title
Randomised Controlled Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Countess of Chester NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chewing gum
Arm Type
Experimental
Arm Description
Patients will chew sugar free gum three times a day
Arm Title
Control
Arm Type
No Intervention
Arm Description
Normal post operative care
Intervention Type
Dietary Supplement
Intervention Name(s)
Chewing gum
Intervention Description
Sugar free chewing gum
Primary Outcome Measure Information:
Title
Bowel function (as assessed by questionnaire)
Description
Time to passage of flatus
Time Frame
Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)
Secondary Outcome Measure Information:
Title
Diet (as assessed by questionnaire)
Description
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)
Title
Length of stay
Time Frame
Days (till successful discharge from secondary care to home or respite care measured up to first 31 days)
Title
Post op nausea and vomiting score (as recorded by visual analogue scale)
Description
Post op nausea and vomiting score (PONV)
Time Frame
Recorded daily for first 5 days
Title
Morbidity
Description
Post operative morbidity
Time Frame
Days (recorded up to 30 days and defined by Clavien-Dindo scale)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent
Exclusion Criteria:
Emergency colorectal surgery, unable to consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dale Vimalachandran, MD FRCS
Phone
4401244365475
Email
dale.vimalachandran@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila Williams
Email
sheila.williams4@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale Vimalachandran, MD FRCS
Organizational Affiliation
Countess of Chester
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rachel Clifford, MRCS
Organizational Affiliation
Countess of Chester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Countess of Chester Hospital
City
Chester
State/Province
Cheshire
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
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