Clinical trial NCT05397158: Optimization of Intestinal Preparation in Older Patients
Official title: Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Older Adults
Keywords: colonoscopy
intestinal preparation
older adults
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 312
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Intestinal preparation Cleanliness assessment
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Blood potassium level before and after intestinal preparation
timeFrame: Up to 1 week
measure: Blood sodium level before and after intestinal preparation
timeFrame: Up to 1 week
measure: Blood glucose level before and after intestinal preparation
timeFrame: Up to 1 week
measure: B-type brain natriuretic peptide (BNP) level before and after intestinal preparation
timeFrame: Up to 1 week
measure: The situation of comfort during the intestinal preparation
timeFrame: Two days
measure: The situation of sleep during the intestinal preparation
timeFrame: One day
measure: The situation of fecal incontinence during the intestinal preparation
timeFrame: One day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
References: