Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy

Adenoma Detection Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507037
• Other study ID #: Gum-1
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2015
• Last updated: March 17, 2016
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Adenoma Detection Rate
• Bowel Preparation Scale

Intervention

Dietary Supplement:
• gum+PEG
chew sugarless gum

Drug:
• polyethylene glycol
2L PEG

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

References & Publications (3)

Ergül B, Filik L, Koçak 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: 10.4 — View 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. — View 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: 10.4103/1319-37 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Scale		2 days	No
Secondary	number of patient tolerability		2 days	No
Secondary	number of patient willingness to repeat preparation		2 days	No
Secondary	Adenoma Detection Rate		2 days	Yes