Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy

Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy: A Prospective Randomized Study

In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 150) used 2 L PEG before colonoscopy. Patients in group B (n = 150) were additionally advised to chew sugarless gum plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by endoscopists who was blinded to the intervention. Difficulty of procedure, patients' tolerance, and adverse events were also evaluated.

Study Overview

• Status: Completed
• Conditions: Adenoma Detection Rate; Bowel Preparation Scale
• Intervention / Treatment: Dietary supplement: gum+PEG; Drug: polyethylene glycol

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All adults (18-65) who were referred for outpatient colonoscopy.

Exclusion Criteria:

• under 18 years or More than 65 years
• previous abdominal surgery
• major psychiatric disorders
• pregnancy
• presence of any contraindications for colonoscopy(eg, severe heart failure)
• recent inadequate colonoscopy history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gum+PEG; used 2L PEG+sugarless gum	Dietary supplement: gum+PEG; chew sugarless gum
Placebo Comparator: PEG; only used 2L PEG	Drug: polyethylene glycol; 2L PEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Boston Bowel Preparation Scale	2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
number of patient tolerability	2 days
number of patient willingness to repeat preparation	2 days
Adenoma Detection Rate	2 days

Collaborators and Investigators

• Sponsor: Changhai Hospital

Publications and helpful links

General Publications

• Sakin YS, Uygun A, Bagci S. Comment on: Efficacy and safety of gum chewing in adjunct to high-dose senna for bowel cleansing before colonoscopy: a single-blind randomized controlled trial. Saudi J Gastroenterol. 2015 Jan-Feb;21(1):56. doi: 10.4103/1319-3767.151233. No abstract available.
• Ergul B, Filik L, Kocak E, Dogan Z, Sarikaya M. Efficacy and safety of gum chewing in adjunct to high-dose senna for bowel cleansing before colonoscopy: a single-blind randomized controlled trial. Saudi J Gastroenterol. 2014 Nov-Dec;20(6):356-9. doi: 10.4103/1319-3767.145325.
• Ou G, Svarta S, Chan C, Galorport C, Qian H, Enns R. The effect of chewing gum on small-bowel transit time in capsule endoscopy: a prospective, randomized trial. Gastrointest Endosc. 2014 Apr;79(4):630-6. doi: 10.1016/j.gie.2013.08.038. Epub 2013 Oct 7.
• Fang J, Wang SL, Fu HY, Li ZS, Bai Y. Impact of gum chewing on the quality of bowel preparation for colonoscopy: an endoscopist-blinded, randomized controlled trial. Gastrointest Endosc. 2017 Jul;86(1):187-191. doi: 10.1016/j.gie.2016.05.051. Epub 2016 Jun 17.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 19, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Estimate): March 18, 2016
• Last Update Submitted That Met QC Criteria: March 17, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: Gum-1