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

Not Applicable

Completed

• Conditions: Colonic Adenoma; Bowel Preparation
• Interventions: Other: split-dose of Magnesium Sulfate solution; Other: split-dose of PEG

• Registration Number: NCT04948567
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-30
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-06-24
• Last Update Submitted: 2021-06-24
• Study First Posted: 2021-07-02
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
split-dose of Magnesium Sulfate solution	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.
split-dose of PEG	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.

Primary Outcome Measures

Name	Time	Method
The rate of patients with adequate bowel preparation	1 year	Defined by each segmental BBPS≥2

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital,; 🇨🇳 Beijing, China

Endoscopic center, Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shanxi, China