The use of chewing gum to enhance recovery after bowel surgery

ISRCTN	ISRCTN72555032
DOI	https://doi.org/10.1186/ISRCTN72555032
Protocol serial number	N/A
Sponsor	King's College London
Funder	Investigator-funded as this study was carried out as part of a MSc programme (UK)

Submission date: 23/07/2008
Registration date: 20/10/2008
Last edited: 17/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Peter Griffiths
Scientific

National Nursing Research Unit
King's College London
Room 4.29b James Clerk Maxwell building
Waterloo Road
London
SE1 8WA
United Kingdom

Phone	+44 (0)20 7848 3012
Email	peter.griffiths@southampton.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised, single-blind, single-centre trial
Secondary study design	Randomised controlled trial
Scientific title	Does chewing (gum) aid recovery after colorectal resection in the context of an enhanced recovery programme? A randomised controlled trial
Study objectives	Chewing gum may enhance recovery from colorectal resection by stimulating bowel motility, shortening post-operative ileus thereby shortening the recovery period.
Ethics approval(s)	Dorset Research Ethics Committee, approved in January 2007 (ref: 06/Q2201/182)
Health condition(s) or problem(s) studied	Colorectal disease (both benign and malignant)
Intervention	Subjects randomised to the treatment group were given sugar-free commercially available chewing gum three times a day for 30 minutes each time from the first post-operative day to day of discharge. The participants in the control group received usual care only.
Intervention type	Other
Primary outcome measure(s)	Length of hospital stay
Key secondary outcome measure(s)	1. Time to first oral fluids 2. Time to first food 3. Time to bowels open 4. Time to flatus 5. Time to fit for discharge
Completion date	01/08/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Elective patients undergoing segmental, partial or sub-total colonic resection for malignant or benign colonic disease 2. Both males and females, over 18 years of age 3. Consent to take part in study
Key exclusion criteria	1. Palliative resection or bypass 2. Concomitant small bowel resection 3. More than one bowel anastomosis during their operation 4. Identified pre-operatively as requiring elective post-operative ventilation or planned intensive care therapy due to co-morbid conditions 5. Allergy to gum or ingredients
Date of first enrolment	01/02/2007
Date of final enrolment	01/08/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

National Nursing Research Unit

London
SE1 8WA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		16/06/2020	17/06/2020	No	No

Additional files

ISRCTN72555032_BasicResults_16Jun2020.pdf: Uploaded 17/06/2020

Editorial Notes

17/06/2020: The basic results of this trial have been uploaded as an additional file.
20/02/2020: Verifying study results status with the principal investigator.