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

NCT06551883 | Completed

• 1 other identifier: Ashley
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bowel Preparation

Keywords

bowel preparation; compound polyethylene glycol electrolyte powder; bowel preparation quality; comfort; tolerability

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• sleep quality

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

• adherence

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

Study Arms (2)

Group A

PLACEBO COMPARATOR

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

Group B

EXPERIMENTAL

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

Interventions

different bowel preparation regime PROCEDURE

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

Group B

traditional bowel preparation regime PROCEDURE

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

Group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Wang Xia

Wuhan, Hubei, 430000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse-in-charge

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 13, 2024
• Study Start: January 1, 2021
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)