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

Primary Purpose

Colonoscopy, Colonic Polyp, Constipation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chewing gum combined with WeChat enhanced instructions
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colonoscopy focused on measuring Bowel preparation, Chewing gum, Enhanced instructions, WeChat, Colonoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chewing gum combined with WeChat enhanced instructions group

Control group

Arm Description

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.

Patients in the control group are guided by regular instructions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Adverse events
Adverse events are defined as the occurrence of gastrointestinal symptoms during bowel preparation, including nausea, vomiting, abdominal pain, and bloating.
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.

Full Information

First Posted
March 25, 2022
Last Updated
February 22, 2023
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT05447403
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Colonic Polyp, Constipation
Keywords
Bowel preparation, Chewing gum, Enhanced instructions, WeChat, Colonoscopy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chewing gum combined with WeChat enhanced instructions group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group are guided by regular instructions.
Intervention Type
Other
Intervention Name(s)
Chewing gum combined with WeChat enhanced instructions
Intervention Description
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 Outcome Measure Information:
Title
Bowel preparation quality
Description
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.
Time Frame
During colonoscopy procedure, an average of 30 minutes
Secondary Outcome Measure Information:
Title
The number of polyp and/or adenoma
Description
The number of polyp and/or adenoma is defined as the number of adenoma/polyp detected during colonoscopy.
Time Frame
During colonoscopy procedure, an average of 30 minutes
Title
Polyp and/or adenoma detection rate
Description
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.
Time Frame
During colonoscopy procedure, an average of 30 minutes
Title
Adverse events
Description
Adverse events are defined as the occurrence of gastrointestinal symptoms during bowel preparation, including nausea, vomiting, abdominal pain, and bloating.
Time Frame
During colonoscopy procedure, an average of 30 minutes
Title
Cecal intubation time
Description
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.
Time Frame
During colonoscopy procedure, an average of 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xingshun Qi, Doctor
Phone
86-18909881019
Email
xingshunqi@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Gao, MD
Phone
86-13309887995
Email
soar1999@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingshun Qi, MD
Organizational Affiliation
The General Hospital of Northern Theater Command
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cong Gao, MS
Organizational Affiliation
The General Hospital of Northern Theater Command
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fei Gao, MD
Organizational Affiliation
The General Hospital of Northern Theater Command
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110840
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingshun Qi, MD
Phone
86-18909881019
Email
xingshunqi@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
26658804
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.
Results Reference
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PubMed Identifier
26818376
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.
Results Reference
background
PubMed Identifier
30418256
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.
Results Reference
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Effect of Chewing Gum and WeChat Enhanced Instructions on the Bowel Preparation Quality in Patients With Constipation

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