Bowel PreparationNCT04605432
FFI and PR Could Improve Bowel Cleansing.
A study testing PEG-FFI and PEG-nonFFI in people with Bowel Preparation, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
background:The use of enhanced instruction can improve the efficiency of education for bowel preparation regimens. Researchers hypothesized that face-to-face instruction and personalized intervention for inpatient could improve successful bowel preparation rate and patient's compliance with regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- PEG-FFI and PEG-nonFFI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2020to 27 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients undergoing colonoscopy.
- patients older than 18 years.
Who cannot join
- prior surgery of colorectal resection;
- suspected colonic stricture or perforation;
- incomplete or complete bowel obstruction;
- use of prokinetic agents or purgatives within 7 days;
- Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;;
- pregnancy or lactation;
- Inability to prepare bowel;
- unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Face-to-face Instructions and Personalized Bowel Cleansing Regimens for Inpatients Could Improve Bowel Preparation Quality.
background:The use of enhanced instruction can improve the efficiency of education for bowel preparation regimens. Researchers hypothesized that face-to-face instruction and personalized intervention for inpatient could improve successful bowel preparation rate and patient's compliance with regimens.
Methods:This was an endoscopist-blind,randomized controlled trial. 320inpatients were randomized 1:1 in one of the two study groups. The intervention group received face-to-face instruction and personalized intervention for bowel preparation protocol, while control group received the standard bowel preparation protocol. Patients'demographics, bowel preparation quality, colonoscopy completion and attendance were recorded. Logistic regression was performed to identify predictors of bowel preparation failure.
- Conditions
- Bowel Preparation
- Being tested
- PEG-FFI, PEG-nonFFI
- Keywords
- bowel preparation; face-to-face instruction; personalized intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-FFIDrug
Patients with risk factor : on the day before the colonoscopy at 20:00- 21:00 hours, 60gPEG-4000 was mixed with 1L water; 4-6 h before colonoscopy, 120gPEG-4000 was mixed with 2L water.
Patient without risk factor: 4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water.
Education completed by experienced researcher.
PEG-nonFFIDrug
All patients on the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water.
Education completed by ward nurse.
| Study group | Role | What they receive |
|---|---|---|
| PEG-FFI prep | Experimental | On the day before colonoscopy, an experienced researcher would go to the ward to have a face-to-face conversation with the patient to know if patients have the risk factors for bowel preparation failure.
The bowel preparation regimens for patients with risk factors would be optimized. In addition to drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min, the patient also drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at 20:00- 21:00 hours on the day before the colonoscopy. Patients without risk factors drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.
Patients would received a booklet to explain the details of diet restriction, preparation method and the pictures of bowel preparation of results.The researcher would give a detailed oral explanation of the booklet. Receives: Drug: PEG-FFI |
| PEG-nonFFI prep | Active comparator | Patients in the PEG-nonFFI group would only receive routine patient education on bowel preparation of colonoscopy, which was completed by ward nurse. all the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. Receives: Drug: PEG-nonFFI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Bowel Preparation
The BBPS is a validated scoring system with scores between 0 and 9, where 9 is the best score. The score comprises a sub score 0-3 for each colon segment: right, transverse and left colon.
For all participants, BBPS score will be used when colonscopy is withdrawing.
Measured: 1 Day of colonoscopy
Secondary outcomes (5)
adverse events
Including nausea, vomiting, abdominal pain and bloating,etc.
Measured: The day of colonoscopy and the day before
cecal intubation rate
The number of colonoscopy reaching the cecal area divided by the total number of colonoscopy
Measured: 1 Day of colonoscopy
polyp detection rate
PDR was defined as the number of patients with at least one polyp divided by the total number of colonoscopy patients
Measured: 1 Day of colonoscopy
cecal intubation time
Time to reach the cecal
Measured: 1 Day of colonoscopy
withdrawal time
Time from withdrawal from the cecum to the end of colonoscopy
Measured: 1 Day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start30 Oct 2020
- Primary completion30 Jun 2021
- Study completion27 Oct 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605432
- Sponsor's protocol ID
- FFI-1.0
- Status last verified
- Jan 2021
- First submitted
- 22 Oct 2020
- Last updated
- 1 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face-to-face Instructions and Personalized Bowel Cleansing Regimens for Inpatients Could Improve Bowel Preparation Quality.
- ClinicalTrials.gov ID
- NCT04605432
- Acronym / sponsor ID
- FFI-1.0
- Conditions
- Bowel Preparation
- Keywords
- bowel preparation; face-to-face instruction; personalized intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 28 Oct 2020 (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.
background:The use of enhanced instruction can improve the efficiency of education for bowel preparation regimens. Researchers hypothesized that face-to-face instruction and personalized intervention for inpatient could improve successful bowel preparation rate and patient's compliance with regimens.
Methods:This was an endoscopist-blind,randomized controlled trial. 320inpatients were randomized 1:1 in one of the two study groups. The intervention group received face-to-face instruction and personalized intervention for bowel preparation protocol, while control group received the standard bowel preparation protocol. Patients'demographics, bowel preparation quality, colonoscopy completion and attendance were recorded. Logistic regression was performed to identify predictors of bowel preparation failure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-FFI prep | Experimental | Drug: PEG-FFIOn the day before colonoscopy, an experienced researcher would go to the ward to have a face-to-face conversation with the patient to know if patients have the risk factors for bowel preparation failure. The bowel preparation regimens for patients with risk factors would be optimized. In addition to drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min, the patient also drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at 20:00- 21:00 hours on the day before the colonoscopy. Patients without risk factors drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. Patients would received a booklet to explain the details of diet restriction, preparation method and the pictures of bowel preparation of results.The researcher would give a detailed oral explanation of the booklet. |
| PEG-nonFFI prep | Active comparator | Drug: PEG-nonFFIPatients in the PEG-nonFFI group would only receive routine patient education on bowel preparation of colonoscopy, which was completed by ward nurse. all the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatients undergoing colonoscopy.
- patients older than 18 years.
Key exclusion criteria (8 listed)
- prior surgery of colorectal resection;
- suspected colonic stricture or perforation;
- incomplete or complete bowel obstruction;
- use of prokinetic agents or purgatives within 7 days;
- Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic 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 |
|---|---|---|
| PEG-FFIPatients with risk factor : on the day before the colonoscopy at 20:00- 21:00 hours, 60gPEG-4000 was mixed with 1L water; 4-6 h before colonoscopy, 120gPEG-4000 was mixed with 2L water. Patient without risk factor: 4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water. Education completed by experienced researcher. | Drug | PEG-FFI prep |
| PEG-nonFFIAll patients on the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water. Education completed by ward nurse. | Drug | PEG-nonFFI prep |
Primary outcome
Quality of Bowel Preparation
Time frame: 1 Day of colonoscopy
The BBPS is a validated scoring system with scores between 0 and 9, where 9 is the best score. The score comprises a sub score 0-3 for each colon segment: right, transverse and left colon. For all participants, BBPS score will be used when colonscopy is withdrawing.
5 secondary outcomes
adverse events
Time frame: The day of colonoscopy and the day before
cecal intubation rate
Time frame: 1 Day of colonoscopy
polyp detection rate
Time frame: 1 Day of colonoscopy
cecal intubation time
Time frame: 1 Day of colonoscopy
withdrawal time
Time frame: 1 Day of colonoscopy
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 1 Nov 2021.
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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 PEG-FFI and PEG-nonFFI in people with Bowel Preparation, run by Ningbo No. 1 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 2 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 1 Nov 2021. 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.
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?
Quality of Bowel Preparation (time frame: 1 Day of colonoscopy). 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 1 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.