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

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

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.

Study Overview

• Status: Completed
• Conditions: Bowel Preparation; Colonic Adenoma
• Intervention / Treatment: Other: split-dose of Magnesium Sulfate solution; Other: split-dose of PEG

• Study Type: Interventional
• Enrollment (Actual): 1174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100853
    • Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital,
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Endoscopic center, Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: split-dose of Magnesium Sulfate solution; purgative for bowel preparation
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.	Other: split-dose of PEG; purgative for bowel preparation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• Ge F, Kang X, Wang Z, Zhu H, Liao L, Wang M, Jia J, Lou L, Guo X, Pan Y, Wan J. Low-dose of magnesium sulfate solution was not inferior to standard regime of polyethylene glycol for bowel preparation in elderly patients: a randomized, controlled study. Scand J Gastroenterol. 2023 Jan;58(1):94-100. doi: 10.1080/00365521.2022.2106154. Epub 2022 Aug 3.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: bowel preparation; Oral magnesium sulfate solution; polyethylene glycol solution
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: KY20170119-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No