Colonic AdenomaNCT04948567
Efficacy of Split-dose of Oral MMS for Bowel Preparation in Elderly Patients
A study testing split-dose of Magnesium Sulfate solution and split-dose of PEG in people with Colonic Adenoma and Bowel Preparation, run by Air Force Military Medical University, China at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Colonic Adenoma, Bowel Preparation
- What is being tested?
- split-dose of Magnesium Sulfate solution and split-dose of PEG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,174 participants
- Where
- 2 sitesChina
- Study dates
- 30 Jan 2017to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who underwent colonoscopy
Who cannot join
- 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;
Show all 9Show fewer
- suspected or confirmed chronic renal insufficiency and heart illness;
- disturbance of electrolytes ;
- unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital,
Beijing, 100853
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi’an, Shanxi, 710032
About this study
Official title: Efficacy of Split-dose of Oral Magnesium Sulfate Solution 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.
- Conditions
- Colonic Adenoma, Bowel Preparation
- Being tested
- split-dose of Magnesium Sulfate solution, split-dose of PEG
- Keywords
- bowel preparation, Oral magnesium sulfate solution, polyethylene glycol solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
split-dose of Magnesium Sulfate solutionOther
purgative for bowel preparation
split-dose of PEGOther
purgative for bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: split-dose of PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients with adequate bowel preparation
Defined by each segmental BBPS≥2
Measured: 1 year
Secondary outcomes (5)
The rate of adenoma detection
The proportion of participants with at least one adenoma in each group
Measured: 1 year
the numbers of patients with adverse events
eg. Vomiting, nausea, abdominal pain
Measured: 1 year
The cecal intubation rate
The rate of colonoscopy reaching the cecum
Measured: 1 year
The time of Cecal intubation
the time between the intubation and visualization of any of the following anatomic landmarks: ileocecal valve, appendiceal orifice, or terminal ileum
Measured: during procedure
the time during Withdrawal phage
the inspection time from cecum to rectum
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start30 Jan 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948567
- Sponsor's protocol ID
- KY20170119-2
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35920250
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Split-dose of Oral Magnesium Sulfate Solution for Bowel Preparation in Elderly Patients
- ClinicalTrials.gov ID
- NCT04948567
- Acronym / sponsor ID
- KY20170119-2
- Conditions
- Colonic Adenoma, Bowel Preparation
- Keywords
- bowel preparation, Oral magnesium sulfate solution, polyethylene glycol solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,174 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| split-dose of Magnesium Sulfate solution | Experimental | Other: split-dose of Magnesium Sulfate solutionThose 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. |
| split-dose of PEG | Placebo comparator | Other: split-dose of PEGPatients 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. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who underwent colonoscopy
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| split-dose of Magnesium Sulfate solutionpurgative for bowel preparation | Other | split-dose of Magnesium Sulfate solution |
| split-dose of PEGpurgative for bowel preparation | Other | split-dose of PEG |
Primary outcome
The rate of patients with adequate bowel preparation
Time frame: 1 year
Defined by each segmental BBPS≥2
5 secondary outcomes
The rate of adenoma detection
Time frame: 1 year
the numbers of patients with adverse events
Time frame: 1 year
The cecal intubation rate
Time frame: 1 year
The time of Cecal intubation
Time frame: during procedure
the time during Withdrawal phage
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Derived from this study: PubMed 35920250Ge 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing split-dose of Magnesium Sulfate solution and split-dose of PEG in people with Colonic Adenoma and Bowel Preparation, run by Air Force Military Medical University, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients with adequate bowel preparation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04948567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.