Clinical trial NCT06551883: Comparison of Split-dose and Single-dose Bowel Preparation Regimens Using Polyethylene Glycol Electrolyte(PEG)
Official title: Comparison of Comfort and Tolerability Between Split-dose and Single-dose Bowel Preparation Regimens Using Polyethylene Glycol Electrolyte: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation
Keywords: bowel preparation
compound polyethylene glycol electrolyte powder
bowel preparation quality
comfort
tolerability
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bowel preparation quality
timeFrame: 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
measure: comfort
timeFrame: Patients self-evaluated their comfort level during the bowel preparation process after it was completed
measure: tolerability
timeFrame: Patients finished the tolerability evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center
Secondary outcomes:
measure: sleep quality
timeFrame: Patients finished the sleep quality evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center
measure: adherence
timeFrame: Patients finished the adherence evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wang Xia
state: Hubei
Study officials:
References: