Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Colonoscopy Cleansing
NCT ID: NCT06728839
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1329 participants
INTERVENTIONAL
2024-12-09
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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1L PEG + 50g Magnesium sulfate (Group A)
Take 50g magnesium sulfate and 1L polyethylene glycol for bowel preparation before colonoscopy
1L PEG + 50g magnesium sulfate
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.
3L PEG alone (Group B)
Take 3L polyethylene glycol for bowel preparation before colonoscopy
3L PEG
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 alone (Group C)
Take 4L polyethylene glycol for bowel preparation before colonoscopy
4L PEG
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.
Interventions
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1L PEG + 50g magnesium sulfate
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.
3L PEG
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
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.
Eligibility Criteria
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Inclusion Criteria
* To undergo screening, surveillance and diagnostic colonoscopy
* Signed written informed consent
Exclusion Criteria
* Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding
* Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon
* Subjects with renal or liver dysfunction, congestive heart failure or rhabdomyolysis
* Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration
* Subjects with constipation (\<3 times a week, difficult defecation, dry stool, less amount)
* Subjects with serious cardiac and cerebrovascular diseases,suffering from metabolic disease or endocrine disease
* Subjects who had previously undergone colorectal resection
* Women with positive pregnancy tests or pregnancy plans, and women in lactation or allergic to the investigational drugs and their ingredients
* Subjects who are participating in other clinical trials or receiving special drugs
* Subjects with any other conditions that the investigator considered inappropriate for inclusion
18 Years
75 Years
ALL
Yes
Sponsors
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The First Affiliated Hospital of Nanchang University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
The Second Hospital of Hebei Medical University
OTHER
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
900 Hospital of Joint Logistics Support Force of PLA
OTHER
Changhai Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhaoshen Li, MD
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Central Contacts
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References
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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.
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.
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.
Other Identifiers
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MGSP-2024
Identifier Type: -
Identifier Source: org_study_id