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Previously, our team compared the effects of a low-residue full nutrition formula podwer (FNFP) combined with 3 liters of polyethylene glycol(PEG) solution and the self-prepared low-residue diet combined with 3 liters of PEG solution on the quality of bowel preparation for colonoscopy, and the results showed that the adequate bowel preparation rate was significantly improved in low-residue full nutrition formula podwer group. However, there are still a considerable number of patients in the process of taking 3L PEG appeared bloating, abdominal pain, nausea, vomiting and other adverse reactions, indicating some subjects can not tolerate the dosage of 3L PEG. In order to reduce adverse reactions and provide more options for people with low PEG tolerance, this study intends to compare the effects of low-residue FNFP combined with 2L PEG and self-provided low-residue diet combined with 3L PEG on the quality bowel preparation, colonoscopy lesions detection, adverse reactions, and tolerance, compliance and satisfaction of subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-residue nutrition formula podwer combined with 2 liters of polyethylene glycol | Experimental |
| |
| Self-prepared low-residue diet combined with 3 liters of polyethylene glycol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-residue full nutrition formula podwer | Dietary Supplement | The day before the colonoscopy, subjects were given a low-residue full nutrition formula podwer instead of a traditional self-prepared low-residue diet. Subjects were given 6 packs (60g/pack) pre-packaged FNFP and asked to use the FNFP according to individual needs. The 2 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 1 liter taken 3-5 hours before the colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Adequate bowel preparation rate | Defined as score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale | Two months |
| Measure | Description | Time Frame |
|---|---|---|
| Excellent bowel preparation rate | Two months | |
| BBPS score (including total score, left colon, transverse colon, and right colon) | Two months | |
| Aronchick Scale score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhaoshen, PhD | Department of Gastroenterology, Changhai Hospital, Navy Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lu'an People's Hospital | Lu'an | Anhui | China | |||
| PLA 909 Hospital |
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|
| Self-prepared low-residue diet | Dietary Supplement | Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy. The 3 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 2 liter taken 4-6 hours before the colonoscopy. |
|
| Two months |
| Bowel preparation completion rate | PEG intake is more than 90% of the requirement | Two weeks |
| Subject satisfaction rate | Two weeks |
| Colonoscopist satisfaction rate | Two weeks |
| Adenoma detection rate | Four weeks |
| Polyp detection rate | Two weeks |
| Compliance with FNFP | Two weeks |
| Quanzhou |
| Fujian |
| China |
| PLA 909 Hospital | Zhangzhou | Fujian | China |
| Huizhou Central People's Hospital | Huizhou | Guangdong | China |
| Jiangmen Central Hospital | Jiangmen | Guangdong | China |
| Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| The First Affiliated Hospital of Hebei North University | Zhangjiakou | Hebei | China |
| Jiangsu Provincial Hospital of Traditional Chinese Medicine | Nanjin | Jiangsu | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
| Nanjing Gulou Hospital | Nanjing | Jiangsu | China |
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | China |
| Jiangsu Subei People's Hospital | Yangzhou | Jiangsu | China |
| Ganzhou People's Hospital | Ganzhou | Jiangxi | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| the central hospital of Dalian | Dalian | Liaoning | China |
| Northern Theater General Hospital | Shenyang | Liaoning | China |
| Shengli Oilfield Central Hospital | Dongying | Shandong | China |
| Shandong Provincial Hospital | Jinan | Shandong | China |
| Changhai Hospital, Naval Medical University | Shanghai | Shanghai Municipality | 200433 | China |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | China |
| Ankang Central Hospital | Ankang | Shanxi | China |
| Yibin Second People's Hospital | Yibin | Sichuan | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| East China Hospital, Fudan University | Shanghai | China |
| Shanghai Seventh People's Hospital | Shanghai | China |