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NCT Number: NCT06551883

Comparison of Split-dose and Single-dose Bowel Preparation Regimens Using Polyethylene Glycol Electrolyte(PEG)

The goal of this quasi-experimental study was to compare the effect of single-dose and split-dose 3L compound polyethylene glycol electrolyte powder (PEG) regimen on the quality, comfort and tolerability of bowel preparation in patients who would undergo colonoscopy examination or treatment.

Participants in group A received a split-dose 3L PEG regimen, with 1L PEG taken on the night before the colonoscopy and 2L PEG taken 4-6 hours before the procedure. Participants in group B received a single-dose 3L PEG taken 4-6 hours before the colonoscopy.

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Key information

Conditions

Bowel Preparation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wang Xia

Wuhan, Hubei, 430000, China

About this study

Related guidelines recommend a split-dose method for bowel preparation. However, this regimen also has limitations, such as affect patients' sleep and that of other patients in the ward, and exacerbate their discomfort due to increased hunger. This quasi-experimental study aims to investigate the effect of single-dose and split-dose 3L compound polyethylene glycol electrolyte powder (PEG) regimen on the quality, comfort and tolerability of bowel preparation.

A total of 101 patients scheduled for colonoscopy in two gastroenterology wards in a Chinese university hospital from January to June 2021 were enrolled in the study.

Patients in one department (group A) were given the 3L PEG in two doses: 1L of PEG was taken from 8:00 pm to 9:00 pm on the night before the examination, and the remaining 2L of PEG were taken from 4:00 am to 6:00 am on the day of the examination, with 250 mL taken every 15 minutes until finished. Patients in the other department (group B) were given 3L of PEG in a single dose, which was taken gradually from around 3-4 am, 4-6 hours before the examination. Patients in group B were also instructed to take 250 mL every 15 minutes until the 3L were finished.

The bowel preparation quality, comfort, sleep quality, adverse reactions, acceptance, and compliance were evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • inpatients aged 18 to 70 years, with informed consent and willingness to cooperate

Exclusion criteria

  • intestinal obstruction and stenosis;
  • a history of PEG allergy;
  • constipation or taking laxatives

Treatment and study plan

different bowel preparation regime

Procedure

Patients in Group B receive the 3L of PEG in a single dose

traditional bowel preparation regime

Procedure

Patients in Group A receive the 3L of PEG in a split dose

Primary outcomes

  1. Bowel preparation quality

    Time frame: The BBPS scores were filled out by the treating physician in the designated area on the patient's examination request form and were collected and organized by the research team immediately after the end of the day's clinic

    Bowel preparation quality was evaluated by the Boston Bowel Preparation Scale (BBPS)

  2. comfort

    Time frame: Patients self-evaluated their comfort level during the bowel preparation process after it was completed

    a self-designed comfort evaluation scale was used, with a linear visual analog rating scale ranging from 0 (comfortable) to 4 (extremely uncomfortable).

  3. tolerability

    Time frame: Patients finished the tolerability evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center

    ①Patients self-assessed whether they were willing to undergo the same bowel preparation method again after the end of bowel preparation; ②Patients self-evaluated the difficulty of completing the bowel cleansing process after bowel preparation, with a score of very difficult (1 point), difficult (2 points), moderate (3 points), easy (4 points), and very easy (5 points)

Secondary outcomes

  1. sleep quality

    Time frame: Patients finished the sleep quality evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center

    Patients self-evaluated the quality of sleep on the night before bowel preparation, which is compared with usual and may be the same or slightly worse.

  2. adherence

    Time frame: Patients finished the adherence evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center

    Patients' compliance with medication was evaluated based on three indicators: whether the patient started taking the medication at the correct time, whether the medication was taken completely according to the instructions, and whether the patient engaged in active exercise after taking the medication

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Comparison of Comfort and Tolerability Between Split-dose and Single-dose Bowel Preparation Regimens Using Polyethylene Glycol Electrolyte: A Quasi-experimental Study

Acronym: PEG

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

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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