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Completed

NCT Number: NCT05397158

Optimization of Intestinal Preparation 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Blood potassium level before and after intestinal preparation

    Time frame: Up to 1 week

    Blood potassium in mmol/L.

  2. Blood sodium level before and after intestinal preparation

    Time frame: Up to 1 week

    Blood sodium in mmol/L.

  3. Blood glucose level before and after intestinal preparation

    Time frame: Up to 1 week

    Blood glucose in mmol/L.

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

    Time frame: Up to 1 week

    BNP in pg/ml.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 31, 2022
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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