Optimization of Intestinal Preparation in Older Patients

NCT ID: NCT05397158

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-07-31

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.

Conditions

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Colonoscopy Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
Endoscopist blind method.

Study Groups

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Single administration of low dose polyethylene glycol group

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.

Group Type EXPERIMENTAL

single administration of low dose polyethylene glycol

Intervention Type PROCEDURE

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

Patients in control group: Take 4L PEG.

control group

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.

Group Type ACTIVE_COMPARATOR

single administration of low dose polyethylene glycol

Intervention Type PROCEDURE

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

Patients in control group: Take 4L PEG.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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YuHe

Identifier Type: -

Identifier Source: org_study_id

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