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

NCT ID: NCT06551883

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-06-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bowel Preparation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Patients in 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.

Group Type PLACEBO_COMPARATOR

traditional bowel preparation regime

Intervention Type PROCEDURE

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

Group B

Patients in 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.

Group Type EXPERIMENTAL

different bowel preparation regime

Intervention Type PROCEDURE

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

Interventions

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different bowel preparation regime

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

Intervention Type PROCEDURE

traditional bowel preparation regime

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xia Wang

nurse-in-charge

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wang Xia

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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Ashley

Identifier Type: -

Identifier Source: org_study_id

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