Clinical trial NCT05447403: Effect of Chewing Gum and WeChat Enhanced Instructions on the Bowel Preparation Quality in Patients With Constipation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Colonic Polyp
Constipation
Keywords: Bowel preparation
Chewing gum
Enhanced instructions
WeChat
Colonoscopy
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bowel preparation quality
timeFrame: During colonoscopy procedure, an average of 30 minutes
Secondary outcomes:
measure: The number of polyp and/or adenoma
timeFrame: During colonoscopy procedure, an average of 30 minutes
measure: Polyp and/or adenoma detection rate
timeFrame: During colonoscopy procedure, an average of 30 minutes
measure: Adverse events
timeFrame: During colonoscopy procedure, an average of 30 minutes
measure: Cecal intubation time
timeFrame: During colonoscopy procedure, an average of 30 minutes
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
state: Liaoning
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Xingshun Qi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The General Hospital of Northern Theater Command
name: Cong Gao, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: The General Hospital of Northern Theater Command
name: Fei Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.