A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05485103

Collaborator

(none)

144

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of modified colonoscopy bowel preparation method compared with traditional method on bowel cleansing effect, colonoscopy examination effect and clinical condition of inflammatory bowel disease patients. Risk factors affecting the quality of bowel preparation will also be studied.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Drug: Polyethylene Glycols	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Modified bowel preparation method group One day before the colonoscopy, only asol (or other intestinal nutrient solution) was taken. On the examination day (4 hours before), 1 bag of polyethylene glycol solution + (2 hours before) glycerin enema 110ml was taken	Drug: Polyethylene Glycols Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations Other Names: glycerin enema asol
Active Comparator: Traditional bowel preparation method group Low residue diet 2 days before the colonoscopy, take 2 bags of polyethylene glycol solution the night before the examination and 1 bag of which on the examination day (4 hours before)	Drug: Polyethylene Glycols Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations Other Names: glycerin enema asol

Arm

Intervention/Treatment

Experimental: Modified bowel preparation method group

One day before the colonoscopy, only asol (or other intestinal nutrient solution) was taken. On the examination day (4 hours before), 1 bag of polyethylene glycol solution + (2 hours before) glycerin enema 110ml was taken

Drug: Polyethylene Glycols

Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations

Other Names:

glycerin enema

asol

Active Comparator: Traditional bowel preparation method group

Low residue diet 2 days before the colonoscopy, take 2 bags of polyethylene glycol solution the night before the examination and 1 bag of which on the examination day (4 hours before)

Drug: Polyethylene Glycols

Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations

Other Names:

glycerin enema

asol

Outcome Measures

Primary Outcome Measures

The quality of bowel preparation evaluated by endoscopists during colonoscopy. [During colonoscopy examination]
The quality of bowel preparation will be evaluated with the Boston bowel preparation scale (BBPS), including the total Boston score (range 0-9, score 8-9 means excellent, 7 means good, less than 7 means bad) and score of per bowel segment (maximum 3).
Number of Participants with increased Disease activity after colonoscopy. [Within 7 days after colonoscopy]
Disease activity will be assessed using C-reactive protein (CRP) measurement, the modified Mayo score in ulcerative colitis and the Crohn's Disease Activity Index score in Crohn's Disease. If the result after colonoscopy was higher than before, the participant may be considered with increased disease activity.

Secondary Outcome Measures

Tolerance score of participants after bowel preparation. [After bowel preparation and before colonoscopy]
Tolerance score is defined range 0-10 (0 means totally intolerant, 10 means feel really good).
Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease after colonoscopy. [Within 30 days after colonoscopy]
Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease within 30 days after colonoscopy.
Number of Participants hospitalized because of aggravation of disease after colonoscopy. [Within 30 days after colonoscopy]
Number of Participants who is hospitalized because of aggravation of disease within 30 days after colonoscopy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis: inflammatory bowel disease (IBD) patients, including ulcerative colitis (UC) and Crohn's disease (CD), have colonic involvement.
Patients and/or family members can understand the study protocol and are willing to participate in the study and provide informed consent in writing.

Exclusion Criteria:

The diagnosis is not definite.
Toxic megacolon, gastrointestinal perforation or other acute abdominal diseases; Patients with gastrointestinal bleeding with unstable vital signs.
Patients after colon surgery.
Serious underlying diseases, organ failure, or inability to cooperate with colonoscopy for other reasons.
Patients can not cooperate with the use of polyethylene glycol or glycerin enema.
Patients or family members cannot understand the conditions and objectives of this study.