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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02372500
• Other study ID #: Surg050/14
• Status: Not yet recruiting
• Phase: N/A
• First received: February 9, 2015
• Last updated: February 20, 2015
• Start date: March 2015
• Est. completion date: October 2016

Study information

• Verified date: February 2015
• Source: Countess of Chester NHS Foundation Trust
• Contact: Dale Vimalachandran, MD FRCS
• Phone: 4401244365475
• Email: dale.vimalachandran[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: October 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Emergency colorectal surgery, unable to consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Surgery

Intervention

Dietary Supplement:
• Chewing gum
Sugar free chewing gum

Locations

Country	Name	City	State
United Kingdom	Countess of Chester Hospital	Chester	Cheshire

Sponsors (1)

Lead Sponsor	Collaborator
Countess of Chester NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel function (as assessed by questionnaire)	Time to passage of flatus	Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)	No
Secondary	Diet (as assessed by questionnaire)	Time to tolerating full diet	Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation)	No
Secondary	Length of stay		Days (till successful discharge from secondary care to home or respite care measured up to first 31 days)	No
Secondary	Post op nausea and vomiting score (as recorded by visual analogue scale)	Post op nausea and vomiting score (PONV)	Recorded daily for first 5 days	No
Secondary	Morbidity	Post operative morbidity	Days (recorded up to 30 days and defined by Clavien-Dindo scale)	Yes