Optimization of Intestinal Preparation in Older Patients

NCT05397158 | Completed

• 1 other identifier: YuHe
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy; Older Adults

Keywords

colonoscopy; intestinal preparation; older adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Blood potassium level before and after intestinal preparation

  Up to 1 week

• Blood sodium level before and after intestinal preparation

  Up to 1 week

• Blood glucose level before and after intestinal preparation

  Up to 1 week

• B-type brain natriuretic peptide (BNP) level before and after intestinal preparation

  Up to 1 week

• The situation of comfort during the intestinal preparation

  Two days

Study Arms (2)

Single administration of low dose polyethylene glycol group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

single administration of low dose polyethylene glycol 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.

Single administration of low dose polyethylene glycol group; control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Endoscopist blind method.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 31, 2022
• Study Start: September 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: August 22, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)