Optimization of Intestinal Preparation in Older Patients

Colonoscopy Clinical Trial

Official title:

Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05397158
• Other study ID #: YuHe
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2022
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age= 50y

• Colonoscopy is planned

• Willing to participate

Exclusion Criteria:

• Age<50y

• Unwilling to participate

• Missing data

Related Conditions & MeSH terms

• Colonoscopy
• Older Adults

Intervention

Procedure:
• single 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.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood potassium level before and after intestinal preparation	Blood potassium in mmol/L.	Up to 1 week
Secondary	Blood sodium level before and after intestinal preparation	Blood sodium in mmol/L.	Up to 1 week
Secondary	Blood glucose level before and after intestinal preparation	Blood glucose in mmol/L.	Up to 1 week
Secondary	B-type brain natriuretic peptide (BNP) level before and after intestinal preparation	BNP in pg/ml.	Up to 1 week
Secondary	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
Secondary	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
Secondary	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