Effect of Chewing Gum and WeChat Enhanced Instructions on the Bowel Preparation Quality in Patients With Constipation

Study Overview
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Brief Summary
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Patients with constipation are more likely to have poor bowel preparation quality due to slow gut motility and poor emptying ability. Gum chewing, as a proxy of sham feeding, is a very simple way used to accelerate gut motility. And a previous study found that enhanced instructions by WeChat could improve bowel preparation quality. Thus, investigators conducted a single-center randomized controlled trial to explore the effect of chewing gum combined with manual enhanced instructions by WeChat on the bowel preparation quality for colonoscopy in patients with constipation.

Detailed Description
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In this randomized controlled trial, consecutive outpatients with constipation for colonoscopy are screened and then randomized into two groups. All enrolled patients will receive 3 liter polyethylene glycol (PEG) for bowel preparation. Patients in the chewing gum and WeChat group (n = 75) are further advised to chew one piece of sugarless gum for 20 minutes after drinking each 1 liter PEG; additionally, they will receive enhanced instructions via WeChat before two days and one day of colonoscopy to further inform how to chew gum and highlight the importance of adequate bowel preparation. Patients in the control group (n = 75) are guided by regular instructions.

Official Title
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Effect of Chewing Gum Combined With Manual Enhanced Instructions by WeChat on the Bowel Preparation Quality for Colonoscopy in Patients With Constipation: a Randomized Controlled Trial

Conditions
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Colonoscopy, Colonic Polyp, Constipation

Intervention / Treatment
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* Other: Chewing gum combined with WeChat enhanced instructions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing colonoscopy at the Department of Gastroenterology of the General Hospital of Northern Theater Command. Patients aged ≥18 years, no gender limitation. Patients who sign informed consent. Patients who are diagnosed with constipation. Exclusion Criteria: Patients who are pregnant or breastfeeding. Patients who are allergic to polyethylene glycol. Patients who are suspected with intestinal obstruction, stenosis or perforation. Patients with mental illness. Patients with serious heart, brain, liver, and kidney diseases. Patients who use WeChat unconditionally by themselves or their family members. Patients who are allergic to chewing gum related ingredients. Patients with the history of colorectal surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chewing gum combined with WeChat enhanced instructions group<br>Patients in the chewing gum and WeChat group are advised to chew one piece of sugarless gum for 20 minutes after drinking each 1 liter PEG. They also receive enhanced instructions via WeChat before two days and one day of colonoscopy to further inform how to chew gum and highlight the importance of adequate bowel preparation. | Other: Chewing gum combined with WeChat enhanced instructions<br>* Patients in the chewing gum and WeChat group are advised to chew one piece of sugarless gum for 20 minutes after drinking each 1 liter PEG. They also receive enhanced instructions via WeChat before two days and one day of colonoscopy to further inform how to chew gum and highlight the importance of adequate bowel preparation.<br>|
| No Intervention: Control group<br>Patients in the control group are guided by regular instructions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation quality | Bowel preparation quality is evaluated by the Boston bowel preparation scale (BBPS) score: Segment score 0: unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Segment score 1: portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. Segment score 2: minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. Segment score 3: entire mucosa of colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid. | During colonoscopy procedure, an average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of polyp and/or adenoma | The number of polyp and/or adenoma is defined as the number of adenoma/polyp detected during colonoscopy. | During colonoscopy procedure, an average of 30 minutes | 
| Polyp and/or adenoma detection rate | Polyp and/or adenoma detection rate (PDR/ADR) is defined as the proportion of patients with at least one histologically confirmed adenoma/polyp detected during colonoscopy. | During colonoscopy procedure, an average of 30 minutes | 
| Adverse events | Adverse events are defined as the occurrence of gastrointestinal symptoms during bowel preparation, including nausea, vomiting, abdominal pain, and bloating. | During colonoscopy procedure, an average of 30 minutes | 
| Cecal intubation time | Cecal intubation time (CIT) is defined as the time from the insertion of the colonoscope tip into the anal verge until reaching the cecal base or cecal end. | During colonoscopy procedure, an average of 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel preparation, Chewing gum, Enhanced instructions, WeChat, Colonoscopy