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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| Shanghai East Hospital | OTHER |
| Shanghai Tong Ren Hospital | OTHER |
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The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in patients referred for CE examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Fast for 12h before the examination and take 8ml of Simethicone Emulsion (Berlin-Chemie, Germany, containing 40 mg simethicone in 1mL emulsion) with 250ml water 30min before capsule ingestion.CE are performed with the Pillcam SB2 capsule endoscopy system (Given Imaging Co. Ltd., Yoqnem, Israel). |
|
| Group B | Active Comparator | the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. |
|
| Group C | Active Comparator | the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. |
|
| Group D | Active Comparator | Group D: the same as protocol A plus 1L Polyethylene glycol 3-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. |
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| Group E | Active Comparator | Group E: the same as protocol A plus 2L Polyethylene glycol 2-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyethylene glycol | Drug |
| ||
| capsule endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| the quality of visualization of the small bowel | The image quality was evaluated only in cases in which the capsule reached the cecum within the examination period. All CE images will be assessed at low speed (10 frames/s) under the AutoView mode of the RAPID workstation (Given Imaging). The intestinal mucosa is defined as clean if, less than 25% of the mucosal surface was covered by dark liquid, bubbles or debris. Using a timer, the investigators record the exact time period during which the small intestinal mucosa was clean. The definition of "excellent" is at least 90% of the overall small bowel mucosa is clean (the sum of "clean" time /total small bowel transit time>90%). And the definition of "good" is at least 80% of the overall small bowel mucosa is clean. We considered that "excellent" or "good" preparation is adequate to make an accurate diagnosis. | one week after CE procedure |
| Measure | Description | Time Frame |
|---|---|---|
| patient acceptability | A visual analogical scale (VAS) is used to evaluate the degree of patients' discomfort. The numerical scale between 0 and 10, with 0 being no burden at all and 10 indicating an intolerable procedure. The questionnaire provide information about whether they experienced nausea, bloating, or any discomfort during the bowel preparation, difficulty to complete the preparation, their willingness to repeat the same preparation in the future (yes or no)and did it affect their daily activity and nocturnal rest. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | China | ||
| Tongren Hospital Affiliated to Shanghai Jiaotong University, China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31682026 | Derived | Wu S, Zhong L, Zheng P, Wang YG, Ding WQ, Yu Q, Hui PP, Chen HM, Gao YJ, Ge ZZ. Low-dose and same day use of polyethylene glycol improves image of video capsule endoscopy: A multi-center randomized clinical trial. J Gastroenterol Hepatol. 2020 Apr;35(4):634-640. doi: 10.1111/jgh.14899. Epub 2019 Dec 15. |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D053704 | Capsule Endoscopy |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Device |
|
| day of CE procedure |
| diagnostic rate | one year |
| Shanghai |
| Shanghai Municipality |
| 200050 |
| China |
| Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |