A randomised trial of gum chewing to reduce post-operative ileus

ISRCTN	ISRCTN55784442
DOI	https://doi.org/10.1186/ISRCTN55784442
Protocol serial number	7704
Sponsor	University Hospitals Bristol NHS Foundation Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 11/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Charlotte Atkinson
Scientific

University of Bristol
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre randomised interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A multicentre randomised interventional trial of chewing sugar-free gum post-operatively to reduce hospital stay and post-operative ileus
Study objectives	The primary hypothesis to be addressed is that chewing sugar-free gum post-operatively reduces the length of hospital stay via a reduction in the duration of ileus. Other hypotheses to be addressed are that chewing sugar-free gum post-operatively reduces co-morbidities associated with ileus (including clinical outcomes such as vomiting, infection, and anastomotic dehiscence), improves quality of life and reduces costs of care.
Ethics approval(s)	North Somerset and South Bristol REC, 29/05/2009, ref: 09/H0106/37
Health condition(s) or problem(s) studied	Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Gastrointestinal
Intervention	200 patients will be randomised to receive usual care plus gum and 200 will be randomised to receive usual care only. Patients in the gum chewing arm will be asked to chew gum for at least 10 minutes four times a day for five days (or until discharge, whichever comes first). Follow-up length: 3 months Study entry: single randomisation only
Intervention type	Other
Primary outcome measure(s)	Length of hospital stay, calculated from date of operation to date of discharge.
Key secondary outcome measure(s)	1. Vomiting, measured during days 1 - 5 post-operation 2. Infection, measured during days 1 - 5 post-operation 3. Anastomotic dehiscence, measured during days 1 - 5 post-operation 4. Quality of life, measured during days 1 - 5 post-operation, and at 6 and 12 weeks post-operation 5. Costs of care, measured during days 1 - 5 post-operation, and at 6 and 12 weeks post-operation
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	400
Key inclusion criteria	We will include a wide range of patients (aged greater than 18 years, either sex) to ensure that the findings of this study will be broadly applicable.
Key exclusion criteria	1. Less than 18 years of age 2. Patients with Crohn's disease (as they may have markedly different nutritional needs and recoveries to most patients undergoing large bowel resection) 3. Emergency cases (non-gastrointestinal [GI] surgeons may do emergency surgery and pre-operative consent may not be possible) 4. Women who are pregnant or lactating
Date of first enrolment	01/04/2009
Date of final enrolment	31/03/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Bristol

Bristol
BS1 2LY
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?
Results article	results	01/07/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/04/2017: Publication reference added.