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

NCT ID: NCT04948567

Last Updated: 2021-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2019-12-01

Brief Summary

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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

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Conditions

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Colonic Adenoma Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

split-dose of Magnesium Sulfate solution

Intervention Type OTHER

purgative for bowel preparation

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.

Group Type PLACEBO_COMPARATOR

split-dose of PEG

Intervention Type OTHER

purgative for bowel preparation

Interventions

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split-dose of Magnesium Sulfate solution

purgative for bowel preparation

Intervention Type OTHER

split-dose of PEG

purgative for bowel preparation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Endoscopic center, Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, China

Site Status

Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital,

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 35920250 (View on PubMed)

Other Identifiers

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KY20170119-2

Identifier Type: -

Identifier Source: org_study_id

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