Health BehaviorNCT02998255
Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients Undergoing Colonoscopy
A study testing Single dose of 2L PEG and Split dose of 4L PEG in people with Health Behavior, run by Air Force Military Medical University, China at 3 sites in China.
Trial summary
Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG still results in lower compliance to the regime and increased cost. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Health Behavior
- What is being tested?
- Single dose of 2L PEG and Split dose of 4L PEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 940 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2016to Aug 2017
- 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
- Patients undergoing colonoscopy;
- Patients with average risks for inadequate BP (Patients were identified average-risk if they did not meet any factor of the following risk factors):
- Constipation
- Diabetes
- Parkinson's disease
- History of stroke or spine cord injure
Show all 9Show fewer
- Prior history of inadequate bowel preparation
- BMI>25
- Use of tricyclic antidepressant or narcotics
Who cannot join
- History of colorectal resection;
- Suspected colonic stricture or perforation;
- Incomplete or complete bowel obstruction;
- Use of prokinetic agents or purgatives within 7 days;
- Toxic colitis or megacolon;
- Pregnancy or lactation;
- Unable to give informed consent;
- Haemodynamically unstable.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Department of gastroenterology, Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710032
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi’an, Shanxi, 710032
Department of gastroenterology, Qinghai Provincial People's Hospital
Xining, Qinghai, 810000
About this study
Official title: Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients
Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG still results in lower compliance to the regime and increased cost.
Some high risk factors for inadequate BP have been identified, including old age, constipation, diabetes, the use of narcotics and prior history of inadequate BP. For average-risk patients without the high risk factors, the procedure of BP could be easier. In the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk patients achieved adequate BP. Here investigators hypothesized that compared with the standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while may be accompanied with better tolerability.
- Conditions
- Health Behavior
- Being tested
- Single dose of 2L PEG, Split dose of 4L PEG
- Keywords
- PEG, Bowel preparation, Colonoscopy
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose of 2L PEGDrug
Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.
Split dose of 4L PEGDrug
All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Single dose of 2L PEG | Experimental | 2 L of PEG solution was used on the day of colonoscopy. Receives: Drug: Single dose of 2L PEG |
| Split-dose of 4L PEG | Active comparator | Split-dose of 4l PEG was used before and on the day of colonoscopy Receives: Drug: Split dose of 4L PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)
The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9.The withdrawal procedure was recorded by vedios. The BBPS and segmental scores in each segment were judged by one endoscopist who was familiar with the criteria of BBPS and blinded to group allocation.
Measured: 1 year
Secondary outcomes (6)
Polyp detection rate
Measured: 1 year
Rate of adverse events
adverse events, such as vomiting, nausea, headache, abdominal pain
Measured: 1 year
Cecal intubation rate
Measured: 1 year
Cecal intubation time
Measured: 1 year
Withdrawal time
Measured: 1 year
Willingness to repeat bowel preparation
The number of patients have a willingness to undergo a repeated bowel preparation if needed
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 940 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998255
- Sponsor's protocol ID
- KY20162097-5
- Status last verified
- Jul 2017
- First submitted
- 30 Nov 2016
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients
- ClinicalTrials.gov ID
- NCT02998255
- Acronym / sponsor ID
- KY20162097-5
- Conditions
- Health Behavior
- Keywords
- PEG, Bowel preparation, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 940 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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.
Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG still results in lower compliance to the regime and increased cost.
Some high risk factors for inadequate BP have been identified, including old age, constipation, diabetes, the use of narcotics and prior history of inadequate BP. For average-risk patients without the high risk factors, the procedure of BP could be easier. In the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk patients achieved adequate BP. Here investigators hypothesized that compared with the standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while may be accompanied with better tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose of 2L PEG | Experimental | Drug: Single dose of 2L PEG2 L of PEG solution was used on the day of colonoscopy. |
| Split-dose of 4L PEG | Active comparator | Drug: Split dose of 4L PEGSplit-dose of 4l PEG was used before and on the day of colonoscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients undergoing colonoscopy;
- Patients with average risks for inadequate BP (Patients were identified average-risk if they did not meet any factor of the following risk factors):
Key exclusion criteria (8 listed)
- History of colorectal resection;
- Suspected colonic stricture or perforation;
- Incomplete or complete bowel obstruction;
- Use of prokinetic agents or purgatives within 7 days;
- Toxic colitis or megacolon;
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 |
|---|---|---|
| Single dose of 2L PEGPatients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes. | Drug | Single dose of 2L PEG |
| Split dose of 4L PEGAll patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy. | Drug | Split-dose of 4L PEG |
Primary outcome
Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)
Time frame: 1 year
The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9.The withdrawal procedure was recorded by vedios. The BBPS and segmental scores in each segment were judged by one endoscopist who was familiar with the criteria of BBPS and blinded to group allocation.
6 secondary outcomes
Polyp detection rate
Time frame: 1 year
Rate of adverse events
Time frame: 1 year
Cecal intubation rate
Time frame: 1 year
Cecal intubation time
Time frame: 1 year
Withdrawal time
Time frame: 1 year
Willingness to repeat bowel preparation
Time frame: 1 year
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 Sep 2017.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single dose of 2L PEG and Split dose of 4L PEG in people with Health Behavior, run by Air Force Military Medical University, China at 3 sites 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 9 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: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2) (time frame: 1 year). 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 Sep 2017.