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Optimization of Intestinal Preparation in Older Patients

Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05397158
Enrollment
312
Registered
2022-05-31
Start date
2021-09-01
Completion date
2022-07-31
Last updated
2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Older Adults

Keywords

colonoscopy, intestinal preparation, older adults

Brief 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. 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.

Interventions

PROCEDUREsingle administration of low dose polyethylene glycol

Patients in single administration of low dose polyethylene glycol (PEG) group: Take 30ml lactulose and 2L PEG. Patients in control group: Take 4L PEG.

Sponsors

Beijing Tongren Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Masking description

Endoscopist blind method.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age≥ 50y * Colonoscopy is planned * Willing to participate

Exclusion criteria

* Age\<50y * Unwilling to participate * Missing data

Design outcomes

Primary

MeasureTime frameDescription
Intestinal preparation Cleanliness assessmentUp to 1 hourThe 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.

Secondary

MeasureTime frameDescription
Blood sodium level before and after intestinal preparationUp to 1 weekBlood sodium in mmol/L.
Blood glucose level before and after intestinal preparationUp to 1 weekBlood glucose in mmol/L.
B-type brain natriuretic peptide (BNP) level before and after intestinal preparationUp to 1 weekBNP in pg/ml.
Blood potassium level before and after intestinal preparationUp to 1 weekBlood potassium in mmol/L.
The situation of sleep during the intestinal preparationOne daySleep situation questionnaire. The length of sleep in hour, the number of awakening, the number of urination and defecation.
The situation of fecal incontinence during the intestinal preparationOne dayFecal incontinence questionnaire. Does the patient have fecal incontinence and the number of fecal incontinence.
The situation of comfort during the intestinal preparationTwo daysComfort situation questionnaire. The score of comfort questionnaire is 1 to 10, 1 represents extremely uncomfortable and 10 represents very comfortable.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026