Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorChanghai Hospital
About this trial
The primary objectives of this project are twofold. On the one hand, it aims to investigate the current status of bowel preparation protocols and their quality in IBD patients undergoing colonoscopy, particularly focusing on the implementation of these protocols across hospitals following the release of the 2023 bowel preparation guidelines. This will further standardize and optimize bowel preparation practices in China. On the other hand, the project seeks to identify and examine various risk factors contributing to poor bowel preparation quality in IBD patients, analyze their correlation with bowel preparation scores, and develop a risk prediction model for failed bowel preparation. This will provide a theoretical foundation for formulating personalized bowel preparation regimens tailored to individual patient conditions in the future.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged 18 years or older, of any gender, scheduled for colonoscopy;
Patients diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 edition of the Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;
Voluntary participation in this study and provision of signed informed consent.
Disqualifiers
History of acute myocardial infarction (within the past 6 months), severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders;
Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders;
Pregnant or lactating women;
Acute intestinal infection within the past 2 weeks;
Trial population
adult patients (aged ≥18 years) diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 Chinese guidelines, who are scheduled to undergo a colonoscopy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard Pre-colonoscopy Bowel Preparation Protocol
Other interventionThis involves standard clinical instructions including a low-residue diet prior to colonoscopy and the administration of bowel cleansing agents (e.g., Polyethylene Glycol) according to the split-dose regimen as per each participating center's routine practice. The timing, dosage, and specific agent used follow existing institutional guidelines.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Observational Cohort for Bowel Preparation in IBD Patients1 intervention
Trial outcomes
Primary outcomes
1
adequate bowel preparation rate
Proportion of subjects with Boston Bowel Preparation Scale (BBPS) scores ≥ 2 in all bowel segments.
Time frame
The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopySecondary outcomes
1
Patient Satisfaction
Patient satisfaction is rated on a 5-point Likert scale ranging from 0 (very dissatisfied) to 5 (very satisfied), with patients rating their satisfaction regarding the entire bowel preparation process from the day before to immediately before the colonoscopy.
Time frame
immediately upon completion of colonoscopySponsors and contacts
Click on the lead sponsor to view all of their trials.
Changhai Hospital
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
Ankang Central Hospital
Collaborator
First People's Hospital of Hangzhou
Collaborator
Jiangmen Central Hospital
Collaborator
Subei People's Hospital of Jiangsu Province
Collaborator
Xijing Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
RenJi Hospital
Collaborator
Ruijin Hospital
Collaborator
Shanghai 10th People's Hospital
Collaborator
ShuGuang Hospital
Collaborator
Shengli Oilfield Hospital
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Source ClinicalTrials.gov