Clinical trial NCT06728839: Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Colonoscopy Cleansing
Official title: Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Bowel Preparation Before Colonoscopy: A Multicentre, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bowel Preparation for Colonoscopy
Keywords: Magnesium sulfate
colonoscopy
bowel preparation
adenoma detection rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Nanchang University
name: The First Affiliated Hospital of Zhengzhou University
name: The Second Hospital of Hebei Medical University
name: Daping Hospital of Army Medical University
name: Ningjin People's Hospital
name: Zibo Central Hospital
name: Zhengzhou Central Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Affiliated Yueqing Hospital of Wenzhou Medical University
name: Qianfoshan Hospital
name: The General Hospital of Western Theater Command
name: Jiangmen Central Hospital
name: The First Affiliated Hospital of Henan University of Science and Technology
name: LiuZhou People's Hospital
name: The Fifth Affiliated Hospital of Zunyi Medical College
name: Yan'an University Affiliated Hospital
name: 900 Hospital of Joint Logistics Support Force of PLA
First posted: 2024-12-11
Enrollment: 1329
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old, male or female
* To undergo screening, surveillance and diagnostic colonoscopy
* Signed written informed consent

Exclusion Criteria:

* Subjects with therapeutic colonoscopy for colorectal polyps
* 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

Primary outcomes:
measure: Adequate bowel preparation rate
timeFrame: 30minutes
Secondary outcomes:
measure: Excellent bowel preparation rate
timeFrame: 30minutes
measure: BBPS score (including total score, left colon, transverse colon, and right colon)
timeFrame: 30minutes
measure: Adenoma detection rate
timeFrame: 10 days
measure: Bowel preparation completion rate
timeFrame: 30minutes
measure: Electrolyte levels
timeFrame: 8 hours
Other outcomes:
Locations:
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.