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Completed

NCT Number: NCT04948567

Efficacy of Split-dose of Oral MMS 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.

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Key information

Conditions

Colonic Adenoma Bowel Preparation

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopic center, Xijing Hospital of Digestive Diseases, Xi’an, Shanxi, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

split-dose of Magnesium Sulfate solution

Other

purgative for bowel preparation

split-dose of PEG

Other

purgative for bowel preparation

Primary outcomes

  1. The rate of patients with adequate bowel preparation

    Time frame: 1 year

    Defined by each segmental BBPS≥2

Secondary outcomes

  1. The rate of adenoma detection

    Time frame: 1 year

    The proportion of participants with at least one adenoma in each group

  2. the numbers of patients with adverse events

    Time frame: 1 year

    eg. Vomiting, nausea, abdominal pain

  3. The cecal intubation rate

    Time frame: 1 year

    The rate of colonoscopy reaching the cecum

  4. The time of Cecal intubation

    Time frame: during procedure

    the time between the intubation and visualization of any of the following anatomic landmarks: ileocecal valve, appendiceal orifice, or terminal ileum

  5. the time during Withdrawal phage

    Time frame: during procedure

    the inspection time from cecum to rectum

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2021
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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