Bowel Preparation for Colonoscopy
Conditions
Keywords
Magnesium sulfate, colonoscopy, bowel preparation, adenoma detection rate
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.
Interventions
DRUG1L 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.
DRUG3L 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.
DRUG4L 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.
Sponsors
The First Affiliated Hospital of Nanchang University
The First Affiliated Hospital of Zhengzhou University
The Second Hospital of Hebei Medical University
Daping Hospital of Army Medical University
Ningjin People's Hospital
Zibo Central Hospital
Zhengzhou Central Hospital
First Affiliated Hospital Xi'an Jiaotong University
Affiliated Yueqing Hospital of Wenzhou Medical University
Qianfoshan Hospital
The General Hospital of Western Theater Command
Jiangmen Central Hospital
The First Affiliated Hospital of Henan University of Science and Technology
LiuZhou People's Hospital
The Fifth Affiliated Hospital of Zunyi Medical College
Yan'an University Affiliated Hospital
900 Hospital of Joint Logistics Support Force of PLA
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate bowel preparation rate | 30minutes | 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
| Measure | Time frame | Description |
|---|---|---|
| Excellent bowel preparation rate | 30minutes | 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) | 30minutes | — |
| Adenoma detection rate | 10 days | — |
| Bowel preparation completion rate | 30minutes | — |
| Electrolyte levels | 8 hours | — |
Contacts
Primary ContactZhaoshen Li, MD
Backup ContactYu Bai, MD
Outcome results
None listed