About this trial
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
This trial accepts healthy volunteersQualifiers
18-75 years old, male or female
To undergo screening, surveillance and diagnostic colonoscopy
Signed written informed consent
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
1L PEG + 50g magnesium sulfate
DrugSubjects 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
DrugSubjects 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
DrugSubjects 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Excellent bowel preparation rate
The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale.
BBPS score (including total score, left colon, transverse colon, and right colon)
Adenoma detection rate
Bowel preparation completion rate
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Changhai Hospital
Lead sponsor
The First Affiliated Hospital of Nanchang University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Daping Hospital of Army Medical University
Collaborator
Ningjin People's Hospital
Collaborator
Zibo Central Hospital
Collaborator
Zhengzhou Central Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Affiliated Yueqing Hospital of Wenzhou Medical University
Collaborator
Qianfoshan Hospital
Collaborator
The General Hospital of Western Theater Command
Collaborator
Jiangmen Central Hospital
Collaborator
The First Affiliated Hospital of Henan University of Science and Technology
Collaborator
LiuZhou People's Hospital
Collaborator
The Fifth Affiliated Hospital of Zunyi Medical College
Collaborator
Yan'an University Affiliated Hospital
Collaborator
900th Hospital of PLA Joint Logistic Support Force
Collaborator
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