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

NCT05447403 | Completed

• 1 other identifier: XHNKKY-CGCW 1.0
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy; Colonic Polyp; Constipation

Keywords

Bowel preparation; Chewing gum; Enhanced instructions; WeChat; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The number of polyp and/or adenoma

  During colonoscopy procedure, an average of 30 minutes

• Polyp and/or adenoma detection rate

  During colonoscopy procedure, an average of 30 minutes

• Adverse events

  During colonoscopy procedure, an average of 30 minutes

• Cecal intubation time

  During colonoscopy procedure, an average of 30 minutes

Study Arms (2)

Chewing gum combined with WeChat enhanced instructions group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients in the control group are guided by regular instructions.

Interventions

Chewing gum combined with WeChat enhanced instructions OTHER

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.

Chewing gum combined with WeChat enhanced instructions group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, 110840, China

Location

Related Publications (3)

• 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.

  PMID: 26658804 BACKGROUND

• 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.

  PMID: 26818376 BACKGROUND

• 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.

  PMID: 30418256 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps; Constipation

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Xingshun Qi, MD

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

• Cong Gao, MS

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

• Fei Gao, MD

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: July 7, 2022
• Study Start: February 24, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CN (1)