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About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.
Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to improve adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are many predictive factors of inadequate bowel preparation such as obesity, constipation, abdominal surgery and so on. By recognizing these risk factors of the patients , we can prescribe the patients with higher dose of bowel cleansing regimen to improve bowel preparation quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: standard group | Active Comparator | Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen. |
|
| Group B: tailored group | Experimental | Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage). Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2L Polyethylene Glycol (PEG) | Drug | Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adequate bowel preparation rates | Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp detection rate | Polyp detection rates between 2 groups | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Yanqing, PhD,MD | Contact | 86-531-82169236 | liyanqing@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Li Yanqing, PhD,MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Qilu Hospital, Shandong University | Ji'nan | Shandong | 250012 | China |
The individual participant data of this trial will be shared when necessary
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.
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|
| 4L Polyethylene Glycol (PEG) | Drug | High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen |
|
|
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |