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

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

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.

Study Overview

• Status: Completed
• Conditions: Bowel Preparation
• Intervention / Treatment: Procedure: traditional bowel preparation regime; Procedure: different bowel preparation regime

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Wang Xia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Procedure: traditional bowel preparation regime; Patients in Group A receive the 3L of PEG in a split dose
Experimental: 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.	Procedure: different bowel preparation regime; Patients in Group B receive the 3L of PEG in a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel preparation quality	Bowel preparation quality was evaluated by the Boston Bowel Preparation Scale (BBPS)	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
comfort	a self-designed comfort evaluation scale was used, with a linear visual analog rating scale ranging from 0 (comfortable) to 4 (extremely uncomfortable).	Patients self-evaluated their comfort level during the bowel preparation process after it was completed
tolerability	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)	Patients finished the tolerability evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep quality	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.	Patients finished the sleep quality evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center
adherence	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	Patients finished the adherence evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 20, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: tolerability; comfort; bowel preparation; bowel preparation quality; compound polyethylene glycol electrolyte powder
• Other Study ID Numbers: Ashley

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No