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Clinical trial

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

ID
Name
ZS-3300
Description
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.
Trial arms
Trial start
2022-09-01
Estimated PCD
2024-07-31
Trial end
2024-12-31
Status
Recruiting
Treatment
Polyethylene Glycols
Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations
Arms:
Modified bowel preparation method group, Traditional bowel preparation method group
Other names:
glycerin enema, asol
Size
144
Primary endpoint
The quality of bowel preparation evaluated by endoscopists during colonoscopy.
During colonoscopy examination
Number of Participants with increased Disease activity after colonoscopy.
Within 7 days after colonoscopy
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 144, 'type': 'ESTIMATED'}}
Updated at
2023-12-26

1 organization

1 product

1 indication

Organization
Peking Union Medical College Hospital
Product
Polyethylene Glycols
Indication
Inflammatory Bowel Disease