Clinical trial NCT05485103: A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: modified bowel preparation method
inflammatory bowel disease
risk factors
quality of bowel preparation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: The quality of bowel preparation evaluated by endoscopists during colonoscopy.
timeFrame: During colonoscopy examination
measure: Number of Participants with increased Disease activity after colonoscopy.
timeFrame: Within 7 days after colonoscopy
Secondary outcomes:
measure: Tolerance score of participants after bowel preparation.
timeFrame: After bowel preparation and before colonoscopy
measure: Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease after colonoscopy.
timeFrame: Within 30 days after colonoscopy
measure: Number of Participants hospitalized because of aggravation of disease after colonoscopy.
timeFrame: Within 30 days after colonoscopy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Sixth Hospital
state: Beijing
city: Ha'erbin
country: China
facility: Heilongjiang Provincial Hospital
state: Heilongjiang
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Shenyang
country: China
facility: The first Hospital of China Medical University
state: Liaoning
city: Baotou
country: China
facility: The second Affiliated Hospital of Baotou Medical Colledge
state: Neimenggu
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Beijing
country: China
facility: Beijing Rectum Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Hui Xu, MD
role: STUDY_CHAIR
References:
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