Bowel PreparationPEGNCT06551883
Comparison of Split-dose and Single-dose Bowel Preparation Regimens Using Polyethylene Glycol Electrolyte(PEG)
A study testing different bowel preparation regime and traditional bowel preparation regime in people with Bowel Preparation, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- different bowel preparation regime and traditional bowel preparation regime
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 20 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inpatients aged 18 to 70 years, with informed consent and willingness to cooperate
Who cannot join
- intestinal obstruction and stenosis;
- a history of PEG allergy;
- constipation or taking laxatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bowel Preparation
- Being tested
- different bowel preparation regime, traditional bowel preparation regime
- Keywords
- bowel preparation, compound polyethylene glycol electrolyte powder, bowel preparation quality, comfort, tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different bowel preparation regimeProcedure or surgery
Patients in Group B receive the 3L of PEG in a single dose
traditional bowel preparation regimeProcedure or surgery
Patients in Group A receive the 3L of PEG in a split dose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: different bowel preparation regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation quality
Bowel preparation quality was evaluated by the Boston Bowel Preparation Scale (BBPS)
Measured: 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).
Measured: 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)
Measured: 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 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.
Measured: 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
Measured: Patients finished the adherence evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jan 2021
- Primary completion20 Jun 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551883
- Sponsor's protocol ID
- Ashley
- Acronym
- PEG
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Comfort and Tolerability Between Split-dose and Single-dose Bowel Preparation Regimens Using Polyethylene Glycol Electrolyte: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT06551883
- Acronym / sponsor ID
- PEG / Ashley
- Conditions
- Bowel Preparation
- Keywords
- bowel preparation, compound polyethylene glycol electrolyte powder, bowel preparation quality, comfort, tolerability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Procedure: traditional bowel preparation regimePatients 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 B | Experimental | Procedure: different bowel preparation regimePatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- inpatients aged 18 to 70 years, with informed consent and willingness to cooperate
Key exclusion criteria (3 listed)
- intestinal obstruction and stenosis;
- a history of PEG allergy;
- constipation or taking laxatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| different bowel preparation regimePatients in Group B receive the 3L of PEG in a single dose | Procedure or surgery | Group B |
| traditional bowel preparation regimePatients in Group A receive the 3L of PEG in a split dose | Procedure or surgery | Group A |
Primary outcome
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)
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).
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)
2 secondary outcomes
sleep quality
Time frame: Patients finished the sleep quality evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center
adherence
Time frame: Patients finished the adherence evaluation by themselves after completing bowel preparation and before being sent to the endoscopy center
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different bowel preparation regime and traditional bowel preparation regime in people with Bowel Preparation, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.