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| Name | Class |
|---|---|
| The First Affiliated Hospital of Nanchang University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
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Magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy. Magnesium sulfate combined with polyethylene glycol is less used in the world. This multicenter, randomized, controlled trial is aimed at to evaluate the efficacy and safety of magnesium sulfate combined with low-volume polyethylene glycol for preoperative bowel preparation for colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1L PEG + 50g Magnesium sulfate (Group A) | Experimental | Take 50g magnesium sulfate and 1L polyethylene glycol for bowel preparation before colonoscopy |
|
| 3L PEG alone (Group B) | Active Comparator | Take 3L polyethylene glycol for bowel preparation before colonoscopy |
|
| 4L PEG alone (Group C) | Active Comparator | Take 4L polyethylene glycol for bowel preparation before colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1L PEG + 50g magnesium sulfate | Drug | Subjects in Group A will use a regimen combining magnesium sulfate and polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. 1 litter of polyethylene glycol is taken at 8pm the day before the colonoscopy and 50 gram of magnesium sulfate is taken 4-6 hours before the colonoscopy, and then drink 2000 ml of water within 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Adequate bowel preparation rate | Defined as the proportion of participants with score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale | 30minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Excellent bowel preparation rate | The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale. | 30minutes |
| BBPS score (including total score, left colon, transverse colon, and right colon) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaoshen Li, MD | Contact | 86-021-31161365 | li.zhaoshen@hotmall.com | |
| Yu Bai, MD | Contact | 86-021-31161335 | baiyu1998@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li, MD | Changhai Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 35920250 | Background | Ge F, Kang X, Wang Z, Zhu H, Liao L, Wang M, Jia J, Lou L, Guo X, Pan Y, Wan J. Low-dose of magnesium sulfate solution was not inferior to standard regime of polyethylene glycol for bowel preparation in elderly patients: a randomized, controlled study. Scand J Gastroenterol. 2023 Jan;58(1):94-100. doi: 10.1080/00365521.2022.2106154. Epub 2022 Aug 3. |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Daping Hospital of Army Medical University |
| OTHER |
| Ningjin People's Hospital | UNKNOWN |
| Zibo Central Hospital | OTHER_GOV |
| Zhengzhou Central Hospital | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Affiliated Yueqing Hospital of Wenzhou Medical University | OTHER |
| Qianfoshan Hospital | OTHER |
| The General Hospital of Western Theater Command | OTHER |
| Jiangmen Central Hospital | OTHER |
| The First Affiliated Hospital of Henan University of Science and Technology | OTHER |
| LiuZhou People's Hospital | OTHER |
| The Fifth Affiliated Hospital of Zunyi Medical College | OTHER |
| Yan'an University Affiliated Hospital | OTHER |
| 900th Hospital of PLA Joint Logistic Support Force | OTHER |
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|
| 3L PEG | Drug | Subjects in Group B will use a regimen with 3L polyethylene glycol for preoperative bowel preparation and undergo 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 liters taken 4-6 hours before the colonoscopy. |
|
| 4L PEG | Drug | Subjects in Group C will use a regimen with 4L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 4 liters of polyethylene glycol solution is taken in split dosing, with 2 liters taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy. |
|
| 30minutes |
| Adenoma detection rate | 10 days |
| Bowel preparation completion rate | 30minutes |
| Electrolyte levels | 8 hours |
| 20485282 | Background | Park SS, Sinn DH, Kim YH, Lim YJ, Sun Y, Lee JH, Kim JY, Chang DK, Son HJ, Rhee PL, Rhee JC, Kim JJ. Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 liters) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy. Am J Gastroenterol. 2010 Jun;105(6):1319-26. doi: 10.1038/ajg.2010.79. Epub 2010 May 18. |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |