Optimization of Intestinal Preparation in Older Patients

Sponsor
Beijing Tongren Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05397158
Collaborator
(none)
350
1
2
30.3
11.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: single administration of low dose polyethylene glycol
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Endoscopist blind method.
Primary Purpose:
Diagnostic
Official Title:
Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients
Actual Study Start Date :
Jun 23, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Intestinal preparation Cleanliness assessment [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.

Secondary Outcome Measures

  1. Blood potassium level before and after intestinal preparation [Up to 1 week]

    Blood potassium in mmol/L.

  2. Blood sodium level before and after intestinal preparation [Up to 1 week]

    Blood sodium in mmol/L.

  3. Blood glucose level before and after intestinal preparation [Up to 1 week]

    Blood glucose in mmol/L.

  4. B-type brain natriuretic peptide (BNP) level before and after intestinal preparation [Up to 1 week]

    BNP in pg/ml.

  5. The situation of comfort during the intestinal preparation [Two days]

    Comfort situation questionnaire. The score of comfort questionnaire is 1 to 10, 1 represents extremely uncomfortable and 10 represents very comfortable.

  6. The situation of sleep during the intestinal preparation [One day]

    Sleep situation questionnaire. The length of sleep in hour, the number of awakening, the number of urination and defecation.

  7. The situation of fecal incontinence during the intestinal preparation [One day]

    Fecal incontinence questionnaire. Does the patient have fecal incontinence and the number of fecal incontinence.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age≥ 50y

  • Colonoscopy is planned

  • Willing to participate

Exclusion Criteria:
  • Age<50y

  • Unwilling to participate

  • Missing data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tongren Hospital Beijing Beijing China

Sponsors and Collaborators

  • Beijing Tongren Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Tongren Hospital
ClinicalTrials.gov Identifier:
NCT05397158
Other Study ID Numbers:
  • YuHe
First Posted:
May 31, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beijing Tongren Hospital

Study Results

No Results Posted as of May 31, 2022