NCT04948567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
Last Updated

July 2, 2021

Status Verified

May 1, 2021

Enrollment Period

2.8 years

First QC Date

May 27, 2021

Last Update Submit

June 24, 2021

Conditions

Colonic AdenomaBowel Preparation

Keywords

bowel preparationOral magnesium sulfate solutionpolyethylene glycol solution

Outcome Measures

Primary Outcomes (1)

  • The rate of patients with adequate bowel preparation

    Defined by each segmental BBPS≥2

    1 year

Secondary Outcomes (5)

  • The rate of adenoma detection

    1 year

  • the numbers of patients with adverse events

    1 year

  • The cecal intubation rate

    1 year

  • The time of Cecal intubation

    during procedure

  • the time during Withdrawal phage

    during procedure

Study Arms (2)

split-dose of Magnesium Sulfate solution

EXPERIMENTAL

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

split-dose of PEG

PLACEBO COMPARATOR

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

Interventions

split-dose of Magnesium Sulfate solutionOTHER

purgative for bowel preparation

split-dose of Magnesium Sulfate solution
split-dose of PEGOTHER

purgative for bowel preparation

split-dose of PEG

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who underwent colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Location

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

Beijing, 100853, China

Location

Related Publications (1)

  • 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.

    PMID: 35920250DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated professor

Study Record Dates

First Submitted

May 27, 2021

First Posted

July 2, 2021

Study Start

January 30, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 2, 2021

Record last verified: 2021-05

Locations

CN(2)