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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChanghai Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-75 years old, male or female

To undergo screening, surveillance and diagnostic colonoscopy

Signed written informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,329 Participants
are divided into 3 treatment groups
Group A: 1L PEG + 50g Magnesium sulfate (Group A)Experimental treatment 1 intervention
Group B: 3L PEG alone (Group B)Active comparator 1 intervention
Group C: 4L PEG alone (Group C)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adequate bowel preparation rate

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

Time frame
30minutes

Secondary outcomes

1

Excellent bowel preparation rate

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

Time frame
30minutes
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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhai Hospital

Lead sponsor

The First Affiliated Hospital of Nanchang University

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

The Second Hospital of Hebei Medical University

Collaborator

Daping Hospital of Army Medical University

Collaborator

Ningjin People's Hospital

Collaborator

Zibo Central Hospital

Collaborator

Zhengzhou Central Hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Affiliated Yueqing Hospital of Wenzhou Medical University

Collaborator

Qianfoshan Hospital

Collaborator

The General Hospital of Western Theater Command

Collaborator

Jiangmen Central Hospital

Collaborator

The First Affiliated Hospital of Henan University of Science and Technology

Collaborator

LiuZhou People's Hospital

Collaborator

The Fifth Affiliated Hospital of Zunyi Medical College

Collaborator

Yan'an University Affiliated Hospital

Collaborator

900th Hospital of PLA Joint Logistic Support Force

Collaborator

This trial is not recruiting at the moment. You can still explore other options: