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

Study Overview
=================
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.

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

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Drug: Polyethylene Glycols


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified bowel preparation method group<br>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<br>* Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations<br>* Other names: asol;|
| Active Comparator: Traditional bowel preparation method group<br>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<br>* Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations<br>* Other names: asol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of bowel preparation evaluated by endoscopists during colonoscopy. | 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). | During colonoscopy examination | 
| Number of Participants with increased Disease activity 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. | Within 7 days after colonoscopy | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
modified bowel preparation method, inflammatory bowel disease, risk factors, quality of bowel preparation