ColonoscopyNCT05447403
Effect of Chewing Gum and WeChat Enhanced Instructions on the Bowel Preparation Quality in Patients With Constipation
A study testing Chewing gum combined with WeChat enhanced instructions in people with Colonoscopy and Colonic Polyp, run by General Hospital of Shenyang Military Region at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Colonic Polyp, Constipation
- What is being tested?
- Chewing gum combined with WeChat enhanced instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2022to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, 110840
About this study
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
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.
Read the 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.
- Conditions
- Colonoscopy, Colonic Polyp, Constipation
- Being tested
- Chewing gum combined with WeChat enhanced instructions
- Keywords
- Bowel preparation, Chewing gum, Enhanced instructions, WeChat, Colonoscopy
- Medical subject headings
- Colonic Polyps, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gum combined with WeChat enhanced instructionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chewing gum combined with WeChat enhanced instructions |
| Control group | No intervention | Patients in the control group are guided by regular instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During colonoscopy procedure, an average of 30 minutes
Secondary outcomes (4)
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.
Measured: During colonoscopy procedure, an average of 30 minutes
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.
Measured: During colonoscopy procedure, an average of 30 minutes
Adverse events
Adverse events are defined as the occurrence of gastrointestinal symptoms during bowel preparation, including nausea, vomiting, abdominal pain, and bloating.
Measured: During colonoscopy procedure, an average of 30 minutes
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.
Measured: During colonoscopy procedure, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start24 Feb 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xingshun Qi, MD, Principal investigator, The General Hospital of Northern Theater CommandCong Gao, MS, Principal investigator, The General Hospital of Northern Theater CommandFei Gao, MD, Principal investigator, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447403
- Sponsor's protocol ID
- XHNKKY-CGCW 1.0
- Status last verified
- Feb 2024
- First submitted
- 25 Mar 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26658804Lee 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.
PubMed 26818376Wang 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.
PubMed 30418256
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05447403
- Acronym / sponsor ID
- XHNKKY-CGCW 1.0
- Conditions
- Colonoscopy, Colonic Polyp, Constipation
- Keywords
- Bowel preparation, Chewing gum, Enhanced instructions, WeChat, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing gum combined with WeChat enhanced instructions group | Experimental | Other: Chewing gum combined with WeChat enhanced instructionsPatients 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. |
| Control group | No intervention | –Patients in the control group are guided by regular instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing gum combined with WeChat enhanced instructionsPatients 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 group |
Primary outcome
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.
4 secondary outcomes
The number of polyp and/or adenoma
Time frame: During colonoscopy procedure, an average of 30 minutes
Polyp and/or adenoma detection rate
Time frame: During colonoscopy procedure, an average of 30 minutes
Adverse events
Time frame: During colonoscopy procedure, an average of 30 minutes
Cecal intubation time
Time frame: During colonoscopy procedure, an average of 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 26658804Lu 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.
- Background: PubMed 26818376Lee 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.
- Background: PubMed 30418256Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xingshun Qi, MD principal investigator
The General Hospital of Northern Theater Command
Cong Gao, MS principal investigator
The General Hospital of Northern Theater Command
Fei Gao, MD principal investigator
The General Hospital of Northern Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing gum combined with WeChat enhanced instructions in people with Colonoscopy and Colonic Polyp, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel preparation quality (time frame: During colonoscopy procedure, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05447403, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.