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Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372500
Recruitment Status : Unknown
Verified February 2015 by Dale Vimalachandran, Countess of Chester NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Dale Vimalachandran, Countess of Chester NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE February 9, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date February 26, 2015
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
Bowel function (as assessed by questionnaire) [ Time Frame: Minutes (end of surgery to first passage of flatus, measured up to 4 weeks) ]
Time to passage of flatus
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • Diet (as assessed by questionnaire) [ Time Frame: Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation) ]
    Time to tolerating full diet
  • Length of stay [ Time Frame: Days (till successful discharge from secondary care to home or respite care measured up to first 31 days) ]
  • Post op nausea and vomiting score (as recorded by visual analogue scale) [ Time Frame: Recorded daily for first 5 days ]
    Post op nausea and vomiting score (PONV)
  • Morbidity [ Time Frame: Days (recorded up to 30 days and defined by Clavien-Dindo scale) ]
    Post operative morbidity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
Official Title  ICMJE Randomised Controlled Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
Brief Summary It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus.
Detailed Description

Patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care.

The primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes).

The trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Colorectal Cancer
  • Surgery
Intervention  ICMJE Dietary Supplement: Chewing gum
Sugar free chewing gum
Study Arms  ICMJE
  • Experimental: Chewing gum
    Patients will chew sugar free gum three times a day
    Intervention: Dietary Supplement: Chewing gum
  • No Intervention: Control
    Normal post operative care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 20, 2015)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent

Exclusion Criteria:

  • Emergency colorectal surgery, unable to consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02372500
Other Study ID Numbers  ICMJE Surg050/14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dale Vimalachandran, Countess of Chester NHS Foundation Trust
Study Sponsor  ICMJE Countess of Chester NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dale Vimalachandran, MD FRCS Countess of Chester
Principal Investigator: Rachel Clifford, MRCS Countess of Chester
PRS Account Countess of Chester NHS Foundation Trust
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP