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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447403
• Other study ID #: XHNKKY-CGCW 1.0
• Status: Completed
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: February 2024
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Colonoscopy
• Constipation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

References & Publications (3)

Lee J, Lee E, Kim Y, Kim E, Lee Y. Effects of gum chewing on abdominal discomfort, nausea, vomiting and intake adherence to polyethylene glycol solution of patients in colonoscopy preparation. J Clin Nurs. 2016 Feb;25(3-4):518-25. doi: 10.1111/jocn.13086. — View Citation

Lu J, Cao Q, Wang X, Pu J, Peng X. Application of Oral Lactulose in Combination With Polyethylene Glycol Electrolyte Powder for Colonoscopy Bowel Preparation in Patients With Constipation. Am J Ther. 2016 Jul-Aug;23(4):e1020-4. doi: 10.1097/MJT.0000000000000351. — View Citation

Wang SL, Wang Q, Yao J, Zhao SB, Wang LS, Li ZS, Bai Y. Effect of WeChat and short message service on bowel preparation: an endoscopist-blinded, randomized controlled trial. Eur J Gastroenterol Hepatol. 2019 Feb;31(2):170-177. doi: 10.1097/MEG.0000000000001303. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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