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
- Interventions
- Drug: Polyethylene Glycols
- Registration Number
- NCT05485103
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modified bowel preparation method group Polyethylene Glycols 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 Traditional bowel preparation method group Polyethylene Glycols 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)
- Primary Outcome Measures
Name Time Method 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.
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).
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (9)
Beijing Sixth Hospital
🇨🇳Beijing, Beijing, China
The second Affiliated Hospital of Baotou Medical Colledge
🇨🇳Baotou, Neimenggu, China
Beijing Rectum Hospital
🇨🇳Beijing, China
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Heilongjiang Provincial Hospital
🇨🇳Ha'erbin, Heilongjiang, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
The first Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China