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

Overview

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.

Full Title of Study: “Efficacy of Split-dose of Oral Magnesium Sulfate Solution for Bowel Preparation in Elderly Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 1, 2019

Interventions

  • Other: split-dose of Magnesium Sulfate solution
    • purgative for bowel preparation
  • Other: split-dose of PEG
    • purgative for bowel preparation

Arms, Groups and Cohorts

  • Experimental: split-dose of Magnesium Sulfate solution
    • 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.
  • Placebo Comparator: split-dose of PEG
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The rate of patients with adequate bowel preparation
    • Time Frame: 1 year
    • Defined by each segmental BBPS≥2

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Air Force Military Medical University, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yanglin Pan, associated professor – Air Force Military Medical University, China

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