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Completed

NCT Number: NCT05447403

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

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.

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Key information

Conditions

Colonoscopy Colonic Polyp Colonic Polyps Constipation Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shenyang, Liaoning, 110840, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Bowel preparation quality

    Time frame: 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 outcomes

  1. The number of polyp and/or adenoma

    Time frame: 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.

  2. Polyp and/or adenoma detection rate

    Time frame: 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.

  3. Adverse events

    Time frame: 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.

  4. Cecal intubation time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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