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

Bowel Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948567
• Other study ID #: KY20170119-2
• Status: Completed
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: May 2021
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1174
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Bowel Preparation
• Colonic Adenoma

Intervention

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

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of patients with adequate bowel preparation	Defined by each segmental BBPS=2	1 year
Secondary	The rate of adenoma detection	The proportion of participants with at least one adenoma in each group	1 year
Secondary	the numbers of patients with adverse events	eg. Vomiting, nausea, abdominal pain	1 year
Secondary	The cecal intubation rate	The rate of colonoscopy reaching the cecum	1 year
Secondary	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
Secondary	the time during Withdrawal phage	the inspection time from cecum to rectum	during procedure