Optimization of Intestinal Preparation in Older Patients

August 21, 2023 updated by: Beijing Tongren Hospital

Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Tongren Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age<50y
  • Unwilling to participate
  • Missing data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal preparation Cleanliness assessment
Time Frame: Up to 1 hour
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
Time Frame: Up to 1 week
Blood potassium in mmol/L.
Up to 1 week
Blood sodium level before and after intestinal preparation
Time Frame: Up to 1 week
Blood sodium in mmol/L.
Up to 1 week
Blood glucose level before and after intestinal preparation
Time Frame: Up to 1 week
Blood glucose in mmol/L.
Up to 1 week
B-type brain natriuretic peptide (BNP) level before and after intestinal preparation
Time Frame: Up to 1 week
BNP in pg/ml.
Up to 1 week
The situation of comfort during the intestinal preparation
Time Frame: Two days
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
Time Frame: One day
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
Time Frame: One day
Fecal incontinence questionnaire. Does the patient have fecal incontinence and the number of fecal incontinence.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YuHe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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