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Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy

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ClinicalTrials.gov Identifier: NCT02507037
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : March 18, 2016
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

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.

Condition or disease Intervention/treatment Phase
Bowel Preparation Scale Adenoma Detection Rate Dietary Supplement: gum+PEG Drug: polyethylene glycol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy: A Prospective Randomized Study
Study Start Date : July 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




Primary Outcome Measures :
  1. Boston Bowel Preparation Scale [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. number of patient tolerability [ Time Frame: 2 days ]
  2. number of patient willingness to repeat preparation [ Time Frame: 2 days ]
  3. Adenoma Detection Rate [ Time Frame: 2 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept., Changhai Hospital
ClinicalTrials.gov Identifier: NCT02507037     History of Changes
Other Study ID Numbers: Gum-1
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms