ColonoscopyNCT05397158
Optimization of Intestinal Preparation in Older Patients
A study testing single administration of low dose polyethylene glycol in people with Colonoscopy and Older Adults, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Older adults are susceptible to intestinal tumors. Colonoscopy can screen colorectal cancer, adenoma and other diseases. There is a large demand for colonoscopy in the older adults, and the risk during peri-colonoscopy period is high. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colonoscopy, Older Adults
- What is being tested?
- single administration of low dose polyethylene glycol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Jul 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 50y
- Colonoscopy is planned
- Willing to participate
Who cannot join
- Age<50y
- Unwilling to participate
- Missing data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients
Older adults are susceptible to intestinal tumors. Colonoscopy can screen colorectal cancer, adenoma and other diseases. There is a large demand for colonoscopy in the older adults, and the risk during peri-colonoscopy period is high. According to the common intestinal preparation methods and the characteristics of the older adults, the investigators propose a modified method, that is single administration of low dose polyethylene glycol (PEG). Specifically, take 30ml lactulose in the morning 1 day before the examination, and eat without residue in lunch and dinner, Take 2L PEG in the morning of the examination day and fast at breakfast and lunch of the day. Taking 4L PEG in 2 days as the control group. The fasting and diarrhea period is shorter in the modified group than that in the control group, and the dose of PEG is less. Lactulose, a laxative, is taken one day before the examination, and the intestinal preparation time is longer than that of single administration. The situation of comfort, sleep and fecal incontinence during the intestinal preparation of the two groups will be compared. The results of electrolyte, blood glucose and B-type brain natriuretic peptide between the two groups will be also compared. The effect of intestinal preparation will be evaluated by the standardization of Boston intestinal preparation scale, and endoscopist blind method will be used in colonoscopy.
Read the detailed description
The participants in control group take 2L PEG the day before the examination, fast at dinner (participants without diabetes) and eat without residue (participants with diabetes). Participants take 2L PEG again in the morning of the examination day, and fasted at breakfast and lunch of the day.
- Conditions
- Colonoscopy, Older Adults
- Being tested
- single administration of low dose polyethylene glycol
- Keywords
- colonoscopy, intestinal preparation, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single administration of low dose polyethylene glycolProcedure or surgery
Patients in single administration of low dose polyethylene glycol (PEG) group: Take 30ml lactulose and 2L PEG.
Patients in control group: Take 4L PEG.
| Study group | Role | What they receive |
|---|---|---|
| Single administration of low dose polyethylene glycol group | Experimental | The patients take 30ml lactulose in the morning 1 day before the examination, and eat without residue in lunch and dinner; Take 2L PEG in the morning of the examination day and fast at breakfast and lunch of the day. Receives: Procedure: single administration of low dose polyethylene glycol |
| control group | Active comparator | The patients in control group take 2L PEG the day before the examination, fast at dinner (patients without diabetes) and eat without residue (patients with diabetes). Patients take 2L PEG again in the morning of the examination day, and fasted at breakfast and lunch of the day. Receives: Procedure: single administration of low dose polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal preparation Cleanliness assessment
The effect of intestinal preparation will be evaluated by Boston Intestinal Preparation Scale.The minimum score is 0，and the maximum score is 9. Higher scores mean a better outcome. Endoscopist blind method will be used.
Measured: Up to 1 hour
Secondary outcomes (7)
Blood potassium level before and after intestinal preparation
Blood potassium in mmol/L.
Measured: Up to 1 week
Blood sodium level before and after intestinal preparation
Blood sodium in mmol/L.
Measured: Up to 1 week
Blood glucose level before and after intestinal preparation
Blood glucose in mmol/L.
Measured: Up to 1 week
B-type brain natriuretic peptide (BNP) level before and after intestinal preparation
BNP in pg/ml.
Measured: Up to 1 week
The situation of comfort during the intestinal preparation
Comfort situation questionnaire. The score of comfort questionnaire is 1 to 10, 1 represents extremely uncomfortable and 10 represents very comfortable.
Measured: Two days
The situation of sleep during the intestinal preparation
Sleep situation questionnaire. The length of sleep in hour, the number of awakening, the number of urination and defecation.
Measured: One day
The situation of fecal incontinence during the intestinal preparation
Fecal incontinence questionnaire. Does the patient have fecal incontinence and the number of fecal incontinence.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Sep 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397158
- Sponsor's protocol ID
- YuHe
- Status last verified
- Jul 2022
- First submitted
- 18 May 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients
- ClinicalTrials.gov ID
- NCT05397158
- Acronym / sponsor ID
- YuHe
- Conditions
- Colonoscopy, Older Adults
- Keywords
- colonoscopy, intestinal preparation, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 31 May 2022 (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.
Older adults are susceptible to intestinal tumors. Colonoscopy can screen colorectal cancer, adenoma and other diseases. There is a large demand for colonoscopy in the older adults, and the risk during peri-colonoscopy period is high. According to the common intestinal preparation methods and the characteristics of the older adults, the investigators propose a modified method, that is single administration of low dose polyethylene glycol (PEG). Specifically, take 30ml lactulose in the morning 1 day before the examination, and eat without residue in lunch and dinner, Take 2L PEG in the morning of the examination day and fast at breakfast and lunch of the day. Taking 4L PEG in 2 days as the control group. The fasting and diarrhea period is shorter in the modified group than that in the control group, and the dose of PEG is less. Lactulose, a laxative, is taken one day before the examination, and the intestinal preparation time is longer than that of single administration. The situation of comfort, sleep and fecal incontinence during the intestinal preparation of the two groups will be compared. The results of electrolyte, blood glucose and B-type brain natriuretic peptide between the two groups will be also compared. The effect of intestinal preparation will be evaluated by the standardization of Boston intestinal preparation scale, and endoscopist blind method will be used in colonoscopy.
Detailed description
The participants in control group take 2L PEG the day before the examination, fast at dinner (participants without diabetes) and eat without residue (participants with diabetes). Participants take 2L PEG again in the morning of the examination day, and fasted at breakfast and lunch of the day.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single administration of low dose polyethylene glycol group | Experimental | Procedure: single administration of low dose polyethylene glycolThe patients take 30ml lactulose in the morning 1 day before the examination, and eat without residue in lunch and dinner; Take 2L PEG in the morning of the examination day and fast at breakfast and lunch of the day. |
| control group | Active comparator | Procedure: single administration of low dose polyethylene glycolThe patients in control group take 2L PEG the day before the examination, fast at dinner (patients without diabetes) and eat without residue (patients with diabetes). Patients take 2L PEG again in the morning of the examination day, and fasted at breakfast and lunch of the day. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥ 50y
- Colonoscopy is planned
- Willing to participate
Key exclusion criteria (3 listed)
- Age<50y
- Unwilling to participate
- Missing data
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 |
|---|---|---|
| single administration of low dose polyethylene glycolPatients in single administration of low dose polyethylene glycol (PEG) group: Take 30ml lactulose and 2L PEG. Patients in control group: Take 4L PEG. | Procedure or surgery | Single administration of low dose polyethylene glycol group, control group |
Primary outcome
Intestinal preparation Cleanliness assessment
Time frame: Up to 1 hour
The effect of intestinal preparation will be evaluated by Boston Intestinal Preparation Scale.The minimum score is 0，and the maximum score is 9. Higher scores mean a better outcome. Endoscopist blind method will be used.
7 secondary outcomes
Blood potassium level before and after intestinal preparation
Time frame: Up to 1 week
Blood sodium level before and after intestinal preparation
Time frame: Up to 1 week
Blood glucose level before and after intestinal preparation
Time frame: Up to 1 week
B-type brain natriuretic peptide (BNP) level before and after intestinal preparation
Time frame: Up to 1 week
The situation of comfort during the intestinal preparation
Time frame: Two days
The situation of sleep during the intestinal preparation
Time frame: One day
The situation of fecal incontinence during the intestinal preparation
Time frame: One day
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 22 Aug 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single administration of low dose polyethylene glycol in people with Colonoscopy and Older Adults, run by Beijing Tongren Hospital at 1 site 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 3 inclusion and 3 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 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Intestinal preparation Cleanliness assessment (time frame: Up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2023.