Condition category
Cancer
Date applied
23/07/2008
Date assigned
20/10/2008
Last edited
06/10/2011
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

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2007

Overall trial end date

01/08/2007

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial participating centre

National Nursing Research Unit
London
SE1 8WA
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

c/o Professor Peter Griffiths
National Nursing Research Unit
Room 4.29b James Clerk Maxwell building
Waterloo Road
London
SE1 8WA
United Kingdom
peter.griffiths@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

No publication intended as of 06/10/2011

Publication citations

Additional files

Editorial Notes