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NCT Number: NCT06728839

Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Colonoscopy Cleansing

Magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy. Magnesium sulfate combined with polyethylene glycol is less used in the world. This multicenter, randomized, controlled trial is aimed at to evaluate the efficacy and safety of magnesium sulfate combined with low-volume polyethylene glycol for preoperative bowel preparation for colonoscopy.

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Key information

Conditions

Bowel Preparation for Colonoscopy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-75 years old, male or female
  • To undergo screening, surveillance and diagnostic colonoscopy
  • Signed written informed consent

Exclusion criteria

  • Subjects with therapeutic colonoscopy for colorectal polyps
  • Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding
  • Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon
  • Subjects with renal or liver dysfunction, congestive heart failure or rhabdomyolysis
  • Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration
  • Subjects with constipation (<3 times a week, difficult defecation, dry stool, less amount)
  • Subjects with serious cardiac and cerebrovascular diseases,suffering from metabolic disease or endocrine disease
  • Subjects who had previously undergone colorectal resection
  • Women with positive pregnancy tests or pregnancy plans, and women in lactation or allergic to the investigational drugs and their ingredients
  • Subjects who are participating in other clinical trials or receiving special drugs
  • Subjects with any other conditions that the investigator considered inappropriate for inclusion

Treatment and study plan

1L PEG + 50g magnesium sulfate

Drug

Subjects in Group A will use a regimen combining magnesium sulfate and polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. 1 litter of polyethylene glycol is taken at 8pm the day before the colonoscopy and 50 gram of magnesium sulfate is taken 4-6 hours before the colonoscopy, and then drink 2000 ml of water within 2 hours.

3L PEG

Drug

Subjects in Group B will use a regimen with 3L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 3 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy.

4L PEG

Drug

Subjects in Group C will use a regimen with 4L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 4 liters of polyethylene glycol solution is taken in split dosing, with 2 liters taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy.

Primary outcomes

  1. Adequate bowel preparation rate

    Time frame: 30minutes

    Defined as the proportion of participants with score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale

Secondary outcomes

  1. Excellent bowel preparation rate

    Time frame: 30minutes

    The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale.

  2. BBPS score (including total score, left colon, transverse colon, and right colon)

    Time frame: 30minutes

  3. Adenoma detection rate

    Time frame: 10 days

  4. Bowel preparation completion rate

    Time frame: 30minutes

  5. Electrolyte levels

    Time frame: 8 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Bai, MD

CONTACT

[email protected]

86-021-31161335

Zhaoshen Li, MD

CONTACT

[email protected]

86-021-31161365

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • 900th Hospital of PLA Joint Logistic Support Force
  • Affiliated Yueqing Hospital of Wenzhou Medical University
  • Daping Hospital of Army Medical University
  • First Affiliated Hospital Xi'an Jiaotong University
  • Jiangmen Central Hospital
  • LiuZhou People's Hospital
  • Ningjin People's Hospital
  • Qianfoshan Hospital
  • The Fifth Affiliated Hospital of Zunyi Medical College
  • The First Affiliated Hospital of Henan University of Science and Technology
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Zhengzhou University
  • The General Hospital of Western Theater Command
  • The Second Hospital of Hebei Medical University
  • Yan'an University Affiliated Hospital
  • Zhengzhou Central Hospital
  • Zibo Central Hospital

Registry information

Official study title

Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Bowel Preparation Before Colonoscopy: A Multicentre, Randomized, Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

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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