Back to results

Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy

Primary Purpose

Bowel Preparation Scale, Adenoma Detection Rate

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

gum+PEG

polyethylene glycol

About this trial

This is an interventional screening trial for Bowel Preparation Scale

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

gum+PEG

PEG

Arm Description

used 2L PEG+sugarless gum

only used 2L PEG

Outcomes

Primary Outcome Measures

Boston Bowel Preparation Scale

Secondary Outcome Measures

number of patient tolerability

number of patient willingness to repeat preparation

Adenoma Detection Rate

Full Information

NCT ID

NCT02507037

First Posted

July 19, 2015

Last Updated

March 17, 2016

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02507037

Brief Title

Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bowel Preparation Scale, Adenoma Detection Rate

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

gum+PEG

Arm Type

Experimental

Arm Description

used 2L PEG+sugarless gum

Arm Title

PEG

Arm Type

Placebo Comparator

Arm Description

only used 2L PEG

Intervention Type

Dietary Supplement

Intervention Name(s)

gum+PEG

Intervention Description

chew sugarless gum

Intervention Type

Drug

Intervention Name(s)

polyethylene glycol

Intervention Description

2L PEG

Primary Outcome Measure Information:

Title

Boston Bowel Preparation Scale

Time Frame

2 days

Secondary Outcome Measure Information:

Title

number of patient tolerability

Time Frame

2 days

Title

number of patient willingness to repeat preparation

Time Frame

2 days

Title

Adenoma Detection Rate

Time Frame

2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

25672242

Citation

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.

Results Reference

result

PubMed Identifier

25434316

Citation

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.

Results Reference

result

PubMed Identifier

24112594

Citation

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.

Results Reference

result

PubMed Identifier

27327849

Citation

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.

Results Reference

derived

Learn more about this trial

Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy

We'll reach out to this number within 24 hrs