A randomised trial of gum chewing to reduce post-operative ileus
| ISRCTN | ISRCTN55784442 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55784442 |
| Secondary identifying numbers | 7704 |
- 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
Scientific
University of Bristol
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
Study information
| Study design | Multicentre randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/04/2009 |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 400; UK sample size: 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
- England
- United Kingdom
Study participating centre
University of Bristol
Bristol
BS1 2LY
United Kingdom
BS1 2LY
United Kingdom
Sponsor information
University Hospitals Bristol NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
| Website | http://www.uhbristol.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/04nm1cv11 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
11/04/2017: Publication reference added.
