Contact information
Type
Scientific
Contact name
Prof Peter Griffiths
ORCID ID
Contact details
National Nursing Research Unit
King's College London
Room 4.29b James Clerk Maxwell building
Waterloo Road
London
SE1 8WA
United Kingdom
+44 (0)20 7848 3012
peter.griffiths@southampton.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Does chewing (gum) aid recovery after colorectal resection in the context of an enhanced recovery programme? A randomised controlled trial
Acronym
Study hypothesis
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)
Study design
Randomised, single-blind, single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
Length of hospital stay
Secondary outcome measures
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
Overall study start date
01/02/2007
Overall study end date
01/08/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
60
Participant 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
Recruitment start date
01/02/2007
Recruitment end date
01/08/2007
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
National Nursing Research Unit
London
SE1 8WA
United Kingdom
Sponsor information
Organisation
King's College London
Sponsor details
c/o Professor Peter Griffiths
National Nursing Research Unit
Room 4.29b James Clerk Maxwell building
Waterloo Road
London
SE1 8WA
England
United Kingdom
-
peter.griffiths@kcl.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Other
Funder name
Investigator-funded as this study was carried out as part of a MSc programme (UK)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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