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

Primary Purpose

Colonic Adenoma, Bowel Preparation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
split-dose of Magnesium Sulfate solution
split-dose of PEG
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Adenoma focused on measuring bowel preparation, Oral magnesium sulfate solution, polyethylene glycol solution

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endoscopic center, Xijing Hospital of Digestive Diseases
  • Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

split-dose of Magnesium Sulfate solution

split-dose of PEG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The rate of patients with adequate bowel preparation
Defined by each segmental BBPS≥2

Secondary Outcome Measures

The rate of adenoma detection
The proportion of participants with at least one adenoma in each group
the numbers of patients with adverse events
eg. Vomiting, nausea, abdominal pain
The cecal intubation rate
The rate of colonoscopy reaching the cecum
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
the time during Withdrawal phage
the inspection time from cecum to rectum

Full Information

First Posted
May 27, 2021
Last Updated
June 24, 2021
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT04948567
Brief Title
Efficacy of Split-dose of Oral MMS for Bowel Preparation in Elderly Patients
Official Title
Efficacy of Split-dose of Oral Magnesium Sulfate Solution for Bowel Preparation in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Adenoma, Bowel Preparation
Keywords
bowel preparation, Oral magnesium sulfate solution, polyethylene glycol solution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
split-dose of Magnesium Sulfate solution
Arm Type
Experimental
Arm Description
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.
Arm Title
split-dose of PEG
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
split-dose of Magnesium Sulfate solution
Intervention Description
purgative for bowel preparation
Intervention Type
Other
Intervention Name(s)
split-dose of PEG
Intervention Description
purgative for bowel preparation
Primary Outcome Measure Information:
Title
The rate of patients with adequate bowel preparation
Description
Defined by each segmental BBPS≥2
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The rate of adenoma detection
Description
The proportion of participants with at least one adenoma in each group
Time Frame
1 year
Title
the numbers of patients with adverse events
Description
eg. Vomiting, nausea, abdominal pain
Time Frame
1 year
Title
The cecal intubation rate
Description
The rate of colonoscopy reaching the cecum
Time Frame
1 year
Title
The time of Cecal intubation
Description
the time between the intubation and visualization of any of the following anatomic landmarks: ileocecal valve, appendiceal orifice, or terminal ileum
Time Frame
during procedure
Title
the time during Withdrawal phage
Description
the inspection time from cecum to rectum
Time Frame
during procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Endoscopic center, Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital,
City
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35920250
Citation
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.
Results Reference
derived

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

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