Bowel Preparation ScalePhase 4NCT03356015
Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
A Phase 4 study testing 4L Polyethylene Glycol and 3L Polyethylene Glycol in people with Bowel Preparation Scale and Adenoma Detection Rate, run by Changhai Hospital at 1 site in China.
Trial summary
High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of the dose of Polyethylene Glycol(PEG) on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation Scale, Adenoma Detection Rate
- What is being tested?
- 4L Polyethylene Glycol and 3L Polyethylene Glycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 1 Feb 2018
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients aged 18-75 years
- Referred for routine diagnostic colonoscopy
- Patients who have signed inform consent form
Who cannot join
- pregnancy or breastfeeding
- allergy to purgatives
- suspected intestinal obstruction, stricture, or perforation
- hemodynamic instability
- impaired swallowing reflex or mental status
- severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure
- history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery
- participation declined.
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
Official title: Comparison of the Efficacy and Tolerability Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of the dose of Polyethylene Glycol(PEG) on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. 3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. 4L-group received 4bags of PEG and were instructed to drink 2 L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.
- Conditions
- Bowel Preparation Scale, Adenoma Detection Rate
- Being tested
- 4L Polyethylene Glycol, 3L Polyethylene Glycol
- Keywords
- Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4L Polyethylene GlycolDrug
4L group received double-dose PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes.
3L Polyethylene GlycolDrug
3L group were instructed to drink 1L PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| 4L Polyethylene Glycol | Experimental | 4L-group received 4 bags of PEG and were instructed to drink 2L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. Receives: Drug: 4L Polyethylene Glycol |
| 3L Polyethylene Glycol | Active comparator | 3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. Receives: Drug: 3L Polyethylene Glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Boston Bowel Preparation Scale
The primary end point of the study was adequate bowel preparation quality de ned as a BBPS total score of ≥6 with all segment scores ≥2
Measured: 2 days
Secondary outcomes (3)
Polyp detection rate
The secondary end point of the study included polyp detection rate
Measured: 2 days
Adenoma detection rate
The secondary end point of the study included adenoma detection rate
Measured: 2 days
The mean number of incremental adenomas
It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation ScaleStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Peng Cheng, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356015
- Sponsor's protocol ID
- PEG-171116
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng P, Chen Q, Li J, Pang L, Feng C, Wang N, Bai Y, Li Z, Meng X. 3 liters of polyethylene glycol vs. standard bowel preparation have equal efficacy in a Chinese population: a randomized, controlled trial. Am J Transl Res. 2022 Aug 15;14(8):5641-5650. eCollection 2022.
PubMed 36105041
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Tolerability Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
- ClinicalTrials.gov ID
- NCT03356015
- Acronym / sponsor ID
- PEG-171116
- Conditions
- Bowel Preparation Scale, Adenoma Detection Rate
- Keywords
- Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 29 Nov 2017 (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.
High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of the dose of Polyethylene Glycol(PEG) on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. 3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. 4L-group received 4bags of PEG and were instructed to drink 2 L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4L Polyethylene Glycol | Experimental | Drug: 4L Polyethylene Glycol4L-group received 4 bags of PEG and were instructed to drink 2L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. |
| 3L Polyethylene Glycol | Active comparator | Drug: 3L Polyethylene Glycol3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients aged 18-75 years
- Referred for routine diagnostic colonoscopy
- Patients who have signed inform consent form
Key exclusion criteria (8 listed)
- pregnancy or breastfeeding
- allergy to purgatives
- suspected intestinal obstruction, stricture, or perforation
- hemodynamic instability
- impaired swallowing reflex or mental status
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 |
|---|---|---|
| 4L Polyethylene Glycol4L group received double-dose PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes. | Drug | 4L Polyethylene Glycol |
| 3L Polyethylene Glycol3L group were instructed to drink 1L PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes | Drug | 3L Polyethylene Glycol |
Primary outcome
the Boston Bowel Preparation Scale
Time frame: 2 days
The primary end point of the study was adequate bowel preparation quality de ned as a BBPS total score of ≥6 with all segment scores ≥2
3 secondary outcomes
Polyp detection rate
Time frame: 2 days
Adenoma detection rate
Time frame: 2 days
The mean number of incremental adenomas
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Derived from this study: PubMed 36105041Cheng P, Chen Q, Li J, Pang L, Feng C, Wang N, Bai Y, Li Z, Meng X. 3 liters of polyethylene glycol vs. standard bowel preparation have equal efficacy in a Chinese population: a randomized, controlled trial. Am J Transl Res. 2022 Aug 15;14(8):5641-5650. eCollection 2022.
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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.
Peng Cheng principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 4L Polyethylene Glycol and 3L Polyethylene Glycol in people with Bowel Preparation Scale and Adenoma Detection Rate, run by Changhai 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Nov 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaosheng Li, MD (+86-21-25070552, zhaoshenlismmu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Boston Bowel Preparation Scale (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356015, which also lists 1 linked publication.
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 29 Nov 2017.