Condition category
Digestive System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
27/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charlotte Atkinson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7704

Study information

Scientific title

A multicentre randomised interventional trial of chewing sugar-free gum post-operatively to reduce hospital stay and post-operative ileus

Acronym

Study hypothesis

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

North Somerset and South Bristol REC, 29/05/2009, ref: 09/H0106/37

Study design

Multicentre randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Length of hospital stay, calculated from date of operation to date of discharge.

Secondary outcome measures

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

Overall trial start date

01/04/2009

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 400; UK sample size: 400

Participant 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

Recruitment start date

01/04/2009

Recruitment end date

31/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS1 2LY
United Kingdom

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust (UK)

Sponsor details

Research and Development
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Sponsor type

Government

Website

http://www.uhbristol.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes