Bowel Cleansing ProcessPhase 4NCT02024022
A Multicenter Single-blind Comparison Between Standard and Individualized Approach in Bowel Preparation Before Colonoscopy
A Phase 4 study testing Standard approach and Individualized approach in people with Bowel Cleansing Process and Colonoscopy, run by Clinical Hospital Colentina at 3 sites in Romania.
Trial summary
This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Cleansing Process, Colonoscopy
- What is being tested?
- Standard approach and Individualized approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 3 sitesRomania
- Study dates
- Feb 2014to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients > 18 years of age undergoing elective colonoscopy on an outpatient basis
Who cannot join
- refusal to sign informed consent
- pregnancy
- advance kidney, liver or heart disease
- suspicion of malignant / benign stenosis of the digestive tract
Trial locations and contacts
3 sites in 1 country.
Romania3 sites
Colentina Clinical Hospital
Bucharest, 020125
Institutul Regional de Gastroenterologie si Hepatologie prof. dr. Octavin Fodor
Cluj-Napoca
Spitalul CFR
Cluj-Napoca
About this study
Official title: A Comparison of Bowel Prep Quality and Patient Satisfaction in Outpatients Undergoing Colonoscopy Preparation With Either a Standard Bowel Preparation or an Individualized Approach Using Sodium Picosulphatge/Magnesium Citrate or 4L Polyethylene Glycol Preparation Regimens
This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.
- Conditions
- Bowel Cleansing Process, Colonoscopy
- Being tested
- Standard approach, Individualized approach
- Keywords
- colonoscopy, bowel cleansing, polyethylene glycol, sodium picosulphate / magnesium citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard approachDrug
bowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate
Individualized approachDrug
Also called 4 L polyethylene glycol or sodium picosulphate / magnesium citrate
| Study group | Role | What they receive |
|---|---|---|
| Standard approach | Active comparator | patients will be randomized to one of the 2 currently used bowel preparation regimens in our clinic:
* 4L split polyethylene glycol solution
* split magnesium citrate/sodium picosulphate preparation regimen Receives: Drug: Standard approach |
| Individualized approach | Experimental | patients will receive either the 4L split polyethylene glycol bowel prep regimen or the sodium picosulphate/magnesium citrate split prep regimen according to personal characteristics assessed using a self-administered questionnaire (including bowel habits, the preference for large-volume preparation and education level) Receives: Drug: Individualized approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel cleansing
bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale)
Measured: 24 hours
Secondary outcomes (1)
patient comfort level during bowel cleansing
patient pain levels on a 0-10 visual analogue scale during the bowel cleansing process
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionDec 2015
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 Cleansing ProcessStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
- Investigators
- Theodor Voiosu, MD, PhD, Principal investigator, Clinical Hospital Colentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024022
- Sponsor's protocol ID
- COL GASTRO 4
- Status last verified
- Jan 2016
- First submitted
- 23 Dec 2013
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Voiosu T, Ratiu I, Voiosu A, Iordache T, Schipor A, Baicus C, Sporea I, Voiosu R. Time for individualized colonoscopy bowel-prep regimens? A randomized controlled trial comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol. J Gastrointestin Liver Dis. 2013 Jun;22(2):129-34.
PubMed 23799210
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Bowel Prep Quality and Patient Satisfaction in Outpatients Undergoing Colonoscopy Preparation With Either a Standard Bowel Preparation or an Individualized Approach Using Sodium Picosulphatge/Magnesium Citrate or 4L Polyethylene Glycol Preparation Regimens
- ClinicalTrials.gov ID
- NCT02024022
- Acronym / sponsor ID
- COL GASTRO 4
- Conditions
- Bowel Cleansing Process, Colonoscopy
- Keywords
- colonoscopy, bowel cleansing, polyethylene glycol, sodium picosulphate / magnesium citrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Dec 2013 (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.
This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard approach | Active comparator | Drug: Standard approachpatients will be randomized to one of the 2 currently used bowel preparation regimens in our clinic: * 4L split polyethylene glycol solution * split magnesium citrate/sodium picosulphate preparation regimen |
| Individualized approach | Experimental | Drug: Individualized approachpatients will receive either the 4L split polyethylene glycol bowel prep regimen or the sodium picosulphate/magnesium citrate split prep regimen according to personal characteristics assessed using a self-administered questionnaire (including bowel habits, the preference for large-volume preparation and education level) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients > 18 years of age undergoing elective colonoscopy on an outpatient basis
Key exclusion criteria (4 listed)
- refusal to sign informed consent
- pregnancy
- advance kidney, liver or heart disease
- suspicion of malignant / benign stenosis of the digestive tract
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 |
|---|---|---|
| Standard approachbowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate | Drug | Standard approach |
| Individualized approachAlso: 4 L polyethylene glycol or sodium picosulphate / magnesium citrate | Drug | Individualized approach |
Primary outcome
bowel cleansing
Time frame: 24 hours
bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale)
1 secondary outcome
patient comfort level during bowel cleansing
Time frame: 24 hours
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 27 Jan 2016.
- Background: PubMed 23799210Voiosu T, Ratiu I, Voiosu A, Iordache T, Schipor A, Baicus C, Sporea I, Voiosu R. Time for individualized colonoscopy bowel-prep regimens? A randomized controlled trial comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol. J Gastrointestin Liver Dis. 2013 Jun;22(2):129-34.
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.
Theodor Voiosu, MD, PhD principal investigator
Clinical Hospital Colentina
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard approach and Individualized approach in people with Bowel Cleansing Process and Colonoscopy, run by Clinical Hospital Colentina at 3 sites in Romania.
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 4 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 27 Jan 2016. 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 Romania. 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?
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 cleansing (time frame: 24 hours). 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 NCT02024022, 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 27 Jan 2016.