Colon PreparationNCT06916689
Efficacy And Tolerability Of Asymmetric Split Regimen For Bowel Preparation
A study testing 1L PEG-Asc in people with Colon Preparation and Polyps Colorectal, run by ASST Rhodense at 1 site in Italy.
Trial summary
The investigators aimed to compare the efficacy for bowel cleansing of a split-dose regimen with a low morning dose of PEG solution (Asymmetric; 25% of the dose is given on the day of the procedure and 75% of the dose is given on the day before) with the standard split-dose regimen in patients undergoing screening and… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Preparation, Polyps Colorectal
- What is being tested?
- 1L PEG-Asc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteItaly
- Study dates
- 8 Mar 2023to 10 Oct 2024
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients scheduled as outpatient for screening or surveillance colonoscopy
Who cannot join
- Inpatients
- refusal of split dose regimen for bowel preparation
- previous history of colorectal resection
- severe cardiac disease
- advanced (stage IV and V) chronic kidney disease
- pregnancy; ileus
Show all 9Show fewer
- suspected bowel obstruction or toxic megacolon
- known inflammatory bowel disease
- known or suspected allergy to PEG.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy And Tolerability Of The Asymmetric Split Regimen With A Very Low Volume Bowel Preparation: Split-The-Split Study
The investigators aimed to compare the efficacy for bowel cleansing of a split-dose regimen with a low morning dose of PEG solution (Asymmetric; 25% of the dose is given on the day of the procedure and 75% of the dose is given on the day before) with the standard split-dose regimen in patients undergoing screening and surveillance colonoscopy using a very low volume bowel preparation (1L PEG+Ascorbate). Consecutive outpatients undergoing screening and surveillance colonoscopy were enrolled in a randomized, single-blind, non-inferiority clinical trial. Patients were randomly assigned to: group A, asymmetric split dose regimen (0,75 L of PEG + ASC the day before and 0,25 L 2:30 hours before colonoscopy); group B, symmetric split dose regimen (0,5 L of PEG + ASC the day before and 0,5 L 3 hours before colonoscopy). Primary endpoint was the proportion of adequate bowel cleansing. Moreover, all patients filled in a validated, nurse-administered questionnaire assessing compliance, tolerability and safety of bowel preparation.
Read the detailed description
Prospective observational, single-blind study conducted in two endoscopy centers belonging to the same Local Health Authority. The two bowel preparation regimens under study (symmetric split and asymmetric split) will be compared in a population of patients undergoing screening for colorectal cancer.
Patient enrollment, product prescription, and the subsequent pre-endoscopic evaluation of safety, tolerability, acceptability, and compliance will be carried out by an assistant who will not be blinded to the type of preparation used.
Endoscopic evaluation, however, will be performed by an experienced endoscopist who will be blinded to the type of bowel preparation administered to the patient.
The bowel preparation product used consists of a very low-volume solution of Macrogol (3350) + Ascorbic Acid (1 liter) (PLENVU®, Norgine).
Bowel cleanliness level assessed using the Boston Bowel Preparation Scale adn overall tolerability of bowel preparation are primary outcomes.
Patient compliance and safety; the number of detected lesions, the percentage of complete colonoscopies, the duration of the colonoscopy, the degree of discomfort/pain perceived by the patient during the examination, and procedure-related complications are secondary outcomes.
Patients will be assigned to the two treatment groups according to a computer-generated sequence.
Data will be expressed as mean and standard deviation for quantitative variables and as frequencies for qualitative variables. The comparison between the two groups will be performed using the t-test for quantitative variables and the chi-square (χ²) test for qualitative variables.
- Conditions
- Colon Preparation, Polyps Colorectal
- Being tested
- 1L PEG-Asc
- Keywords
- Asymmetric split regimen, Bowel preparation, Colon cleansing, Very low volume preparation, 1L PEG + ascorbate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1L PEG-AscDrug
PEG 3350 plus sodium sulfate plus sodium chloride plus potassium chloride plus ascorbic acid plus sodium ascorbate
| Study group | Role | What they receive |
|---|---|---|
| Asymmetric split dose preparation | Experimental | 75% of the dose is given on the day before of the procedure and 25% of the dose is given on the day of the procedure Receives: Drug: 1L PEG-Asc |
| Symmetric split dose preparation | Active comparator | 50% of the dose is given on the day before of the procedure and 50% of the dose is given on the day of the procedure Receives: Drug: 1L PEG-Asc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel prepreparation
Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale. Each segment of the colon received a score from 0 to 3, and these segment scores were summed for a total BBPS score ranging from 0 to 9. The preparation was considered adequate when BBPS score was ≥ 6 with a score with at least 2 points in any segment
Measured: 2 days
Secondary outcomes (4)
Adenoma detection rate
rate of patients with at least one adenoma
Measured: 2 days
Rate of the occurrence of adverse events
Rate of the occurrence of adverse events (bad taste in mouth, gastric fullness, nausea or vomiting, bloating, abdominal pain, headache)
Measured: 2 days
Compliance
Compliance was assessed by the amount of intake of study agents using a 3-point scale: 1 (100% intake), 2 (≥ 75% intake), and 3 (< 75% intake).
Measured: 2 days
Tolerability of the preparation, as reported by the patient on a Validated Questionnaire
Tolerability was evaluated assessing how patient finds tolerable the bowel preparation by using a 4-point scale: 1 (Easy), 2 (Acceptable), 3 (Somewhat difficult), 4 (Very difficult), plus a Visual Scale with a number from 0 (untolerable) to 100 (very tolerable).
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 posted8 Apr 2025
- Study start8 Mar 2023
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Rhodense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gianpiero manes, ASST Rhodense
- Investigators
- Gianpiero Manes, Principal investigator, ASST Rhodense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916689
- Sponsor's protocol ID
- 101-17022023
- Status last verified
- Mar 2023
- First submitted
- 1 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Tolerability Of The Asymmetric Split Regimen With A Very Low Volume Bowel Preparation: Split-The-Split Study
- ClinicalTrials.gov ID
- NCT06916689
- Acronym / sponsor ID
- 101-17022023
- Conditions
- Colon Preparation, Polyps Colorectal
- Keywords
- Asymmetric split regimen, Bowel preparation, Colon cleansing, Very low volume preparation, 1L PEG + ascorbate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- ASST RhodenseUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 8 Apr 2025 (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 investigators aimed to compare the efficacy for bowel cleansing of a split-dose regimen with a low morning dose of PEG solution (Asymmetric; 25% of the dose is given on the day of the procedure and 75% of the dose is given on the day before) with the standard split-dose regimen in patients undergoing screening and surveillance colonoscopy using a very low volume bowel preparation (1L PEG+Ascorbate). Consecutive outpatients undergoing screening and surveillance colonoscopy were enrolled in a randomized, single-blind, non-inferiority clinical trial. Patients were randomly assigned to: group A, asymmetric split dose regimen (0,75 L of PEG + ASC the day before and 0,25 L 2:30 hours before colonoscopy); group B, symmetric split dose regimen (0,5 L of PEG + ASC the day before and 0,5 L 3 hours before colonoscopy). Primary endpoint was the proportion of adequate bowel cleansing. Moreover, all patients filled in a validated, nurse-administered questionnaire assessing compliance, tolerability and safety of bowel preparation.
Detailed description
Prospective observational, single-blind study conducted in two endoscopy centers belonging to the same Local Health Authority. The two bowel preparation regimens under study (symmetric split and asymmetric split) will be compared in a population of patients undergoing screening for colorectal cancer.
Patient enrollment, product prescription, and the subsequent pre-endoscopic evaluation of safety, tolerability, acceptability, and compliance will be carried out by an assistant who will not be blinded to the type of preparation used.
Endoscopic evaluation, however, will be performed by an experienced endoscopist who will be blinded to the type of bowel preparation administered to the patient.
The bowel preparation product used consists of a very low-volume solution of Macrogol (3350) + Ascorbic Acid (1 liter) (PLENVU®, Norgine).
Bowel cleanliness level assessed using the Boston Bowel Preparation Scale adn overall tolerability of bowel preparation are primary outcomes.
Patient compliance and safety; the number of detected lesions, the percentage of complete colonoscopies, the duration of the colonoscopy, the degree of discomfort/pain perceived by the patient during the examination, and procedure-related complications are secondary outcomes.
Patients will be assigned to the two treatment groups according to a computer-generated sequence.
Data will be expressed as mean and standard deviation for quantitative variables and as frequencies for qualitative variables. The comparison between the two groups will be performed using the t-test for quantitative variables and the chi-square (χ²) test for qualitative variables.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymmetric split dose preparation | Experimental | Drug: 1L PEG-Asc75% of the dose is given on the day before of the procedure and 25% of the dose is given on the day of the procedure |
| Symmetric split dose preparation | Active comparator | Drug: 1L PEG-Asc50% of the dose is given on the day before of the procedure and 50% of the dose is given on the day of the procedure |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled as outpatient for screening or surveillance colonoscopy
Key exclusion criteria (9 listed)
- Inpatients
- refusal of split dose regimen for bowel preparation
- previous history of colorectal resection
- severe cardiac disease
- advanced (stage IV and V) chronic kidney disease
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 |
|---|---|---|
| 1L PEG-AscPEG 3350 plus sodium sulfate plus sodium chloride plus potassium chloride plus ascorbic acid plus sodium ascorbate | Drug | Asymmetric split dose preparation, Symmetric split dose preparation |
Primary outcome
Quality of bowel prepreparation
Time frame: 2 days
Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale. Each segment of the colon received a score from 0 to 3, and these segment scores were summed for a total BBPS score ranging from 0 to 9. The preparation was considered adequate when BBPS score was ≥ 6 with a score with at least 2 points in any segment
4 secondary outcomes
Adenoma detection rate
Time frame: 2 days
Rate of the occurrence of adverse events
Time frame: 2 days
Compliance
Time frame: 2 days
Tolerability of the preparation, as reported by the patient on a Validated Questionnaire
Time frame: 2 days
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 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Gianpiero Manes principal investigator
ASST Rhodense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1L PEG-Asc in people with Colon Preparation and Polyps Colorectal, run by ASST Rhodense at 1 site in Italy.
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 9 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 Apr 2025. 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 Italy. 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 prepreparation (time frame: 2 days). 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 Apr 2025.