Efficacy of Split-dose of Oral MMS for Bowel Preparation in Elderly Patients

Study Overview
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Brief Summary
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Adequate bowel preparation is critical for successful colonoscopy and a large volume of PEG was required for bowel preparation in patients undergoing colonoscopy. The investigators conducted a a prospective, randomized, controlled study to compare low dose of oral magnesium sulfate solution with high dose PEG. The investigators found that patients who took low dose of oral magnesium sulfate solution had similar bowel preparation quality to patients who took PEG,but accompanied with fewer adverse events and better tolerance.

Official Title
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Efficacy of Split-dose of Oral Magnesium Sulfate Solution for Bowel Preparation in Elderly Patients

Conditions
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Colonic Adenoma, Bowel Preparation

Intervention / Treatment
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* Other: split-dose of Magnesium Sulfate solution
* Other: split-dose of PEG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who underwent colonoscopy Exclusion Criteria: known or suspected bowel stricture or obstruction; history of colorectal surgery; significant gastroparesis or gastric outlet obstruction; toxic colitis or megacolon; severe acute inflammatory bowel disease; active gastrointestinal bleeding; suspected or confirmed chronic renal insufficiency and heart illness; disturbance of electrolytes ; unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: split-dose of Magnesium Sulfate solution<br>Those assigned to MSS group were instructed to take 30ml of 50% magnesium sulfate solution and then drink 600ml water on the evening before colonoscopy. 70ml of 50% MMS and then 1500ml water was taken at least 4 hours before procedure on the colonoscopy day. | Other: split-dose of Magnesium Sulfate solution<br>* purgative for bowel preparation<br>|
| Placebo Comparator: split-dose of PEG<br>Patients in PEG group were instructed to take first dose of 1.5L PEG on the evening before colonoscopy and take the second dose of 1.5L PEG at least 4 hours before the colonoscopy procedure on the morning. | Other: split-dose of PEG<br>* purgative for bowel preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of patients with adequate bowel preparation | Defined by each segmental BBPS≥2 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of adenoma detection | The proportion of participants with at least one adenoma in each group | 1 year | 
| the numbers of patients with adverse events | eg. Vomiting, nausea, abdominal pain | 1 year | 
| The cecal intubation rate | The rate of colonoscopy reaching the cecum | 1 year | 
| The time of Cecal intubation | the time between the intubation and visualization of any of the following anatomic landmarks: ileocecal valve, appendiceal orifice, or terminal ileum | during procedure | 
| the time during Withdrawal phage | the inspection time from cecum to rectum | during procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel preparation, Oral magnesium sulfate solution, polyethylene glycol solution