Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy

NCT ID: NCT02507037

Last Updated: 2016-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bowel Preparation Scale Adenoma Detection Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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gum+PEG

used 2L PEG+sugarless gum

Group Type EXPERIMENTAL

gum+PEG

Intervention Type DIETARY_SUPPLEMENT

chew sugarless gum

PEG

only used 2L PEG

Group Type PLACEBO_COMPARATOR

polyethylene glycol

Intervention Type DRUG

2L PEG

Interventions

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gum+PEG

chew sugarless gum

Intervention Type DIETARY_SUPPLEMENT

polyethylene glycol

2L PEG

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology Dept.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 25672242 (View on PubMed)

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.

Reference Type RESULT
PMID: 25434316 (View on PubMed)

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.

Reference Type RESULT
PMID: 24112594 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27327849 (View on PubMed)

Other Identifiers

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Gum-1

Identifier Type: -

Identifier Source: org_study_id

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