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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Surgery
• Intervention / Treatment: Dietary supplement: Chewing gum

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: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dale Vimalachandran, MD FRCS; Phone Number: 4401244365475; Email: dale.vimalachandran@nhs.net
• Study Contact Backup: Name: Sheila Williams; Email: sheila.williams4@nhs.net

Study Locations

• United Kingdom
  • Cheshire
    • Chester, Cheshire, United Kingdom, CH2 1UL
      • Countess of Chester Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Emergency colorectal surgery, unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chewing gum; Patients will chew sugar free gum three times a day	Dietary supplement: Chewing gum; Sugar free chewing gum
No Intervention: Control; Normal post operative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Length of stay		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)	Post op nausea and vomiting score (PONV)	Recorded daily for first 5 days
Morbidity	Post operative morbidity	Days (recorded up to 30 days and defined by Clavien-Dindo scale)

Collaborators and Investigators

• Sponsor: Countess of Chester NHS Foundation Trust
• Investigators: Study Director: Dale Vimalachandran, MD FRCS, Countess of Chester; Principal Investigator: Rachel Clifford, MRCS, Countess of Chester

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Surg050/14