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

Not Applicable

Completed

• Conditions: Constipation; Colonoscopy; Colonic Polyp
• Interventions: Other: Chewing gum combined with WeChat enhanced instructions

• Registration Number: NCT05447403
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-02-24
• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-07
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

1. Patients undergoing colonoscopy at the Department of Gastroenterology of the General Hospital of Northern Theater Command.
2. Patients aged ≥18 years, no gender limitation.
3. Patients who sign informed consent.
4. Patients who are diagnosed with constipation.

Exclusion Criteria

1. Patients who are pregnant or breastfeeding.
2. Patients who are allergic to polyethylene glycol.
3. Patients who are suspected with intestinal obstruction, stenosis or perforation.
4. Patients with mental illness.
5. Patients with serious heart, brain, liver, and kidney diseases.
6. Patients who use WeChat unconditionally by themselves or their family members.
7. Patients who are allergic to chewing gum related ingredients.
8. Patients with the history of colorectal surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chewing gum combined with WeChat enhanced instructions group	Chewing gum combined with WeChat enhanced instructions	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.

Primary Outcome Measures

Name	Time	Method
Bowel preparation quality	During colonoscopy procedure, an average of 30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
The number of polyp and/or adenoma	During colonoscopy procedure, an average of 30 minutes	The number of polyp and/or adenoma is defined as the number of adenoma/polyp detected during colonoscopy.
Cecal intubation time	During colonoscopy procedure, an average of 30 minutes	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.
Polyp and/or adenoma detection rate	During colonoscopy procedure, an average of 30 minutes	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.
Adverse events	During colonoscopy procedure, an average of 30 minutes	Adverse events are defined as the occurrence of gastrointestinal symptoms during bowel preparation, including nausea, vomiting, abdominal pain, and bloating.

Trial Locations

Locations (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area); 🇨🇳 Shenyang, Liaoning, China