Optimization of Intestinal Preparation in Older Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients

Conditions
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Colonoscopy, Older Adults

Intervention / Treatment
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* Procedure: single administration of low dose polyethylene glycol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥ 50y Colonoscopy is planned Willing to participate Exclusion Criteria: Age<50y Unwilling to participate Missing data

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single administration of low dose polyethylene glycol group<br>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. | Procedure: single administration of low dose polyethylene glycol<br>* Patients in single administration of low dose polyethylene glycol (PEG) group: Take 30ml lactulose and 2L PEG. Patients in control group: Take 4L PEG.<br>|
| Active Comparator: control group<br>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. | Procedure: single administration of low dose polyethylene glycol<br>* Patients in single administration of low dose polyethylene glycol (PEG) group: Take 30ml lactulose and 2L PEG. Patients in control group: Take 4L PEG.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood potassium level before and after intestinal preparation | Blood potassium in mmol/L. | Up to 1 week | 
| Blood sodium level before and after intestinal preparation | Blood sodium in mmol/L. | Up to 1 week | 
| Blood glucose level before and after intestinal preparation | Blood glucose in mmol/L. | Up to 1 week | 
| B-type brain natriuretic peptide (BNP) level before and after intestinal preparation | BNP in pg/ml. | 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. | 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. | 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. | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, intestinal preparation, older adults