Colonoscopy PreparationNCT01596686
Comparison of Preparation Regimens for Colonoscopy
A study testing one of two possible colon preparation regimens in people with Colonoscopy Preparation, run by Clinical Hospital Colentina at 2 sites in Romania.
Trial summary
The investigators intend to study the impact of two different preparation regimens for colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient tolerability. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- one of two possible colon preparation regimens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesRomania
- Study dates
- May 2012to Feb 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients undergoing colonoscopy
Who cannot join
- patient refusal to sign informed consent
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Colentina Clinical Hospital
Bucharest, Bucharest
Spitalul clinic judetean
Timișoara, Timisoara, 300783
About this study
The investigators intend to study the impact of two different preparation regimens for colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient tolerability.
- Conditions
- Colonoscopy Preparation
- Being tested
- one of two possible colon preparation regimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one of two possible colon preparation regimensDrug
Also called Fortrans, Picoprep
Patients are randomized to receive one of the two different preparation regimens for colonoscopy usually employed in our unit, polyethylene glycol or sodium picosulphate and magnesium citrate
| Study group | Role | What they receive |
|---|---|---|
| sodium picosulphate and magnesium citrate (Picoprep) | Active comparator | Not described Receives: Drug: one of two possible colon preparation regimens |
| polyethylene glycol (Fortrans) | Active comparator | Not described Receives: Drug: one of two possible colon preparation regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
colon preparation
the impact of colon preparation as assessed by the endoscopist (scale from 1 to 4, 1 representing the worst and 4 the best prepared colon) on the quality of the endoscopic examination
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596686
- Sponsor's protocol ID
- COL-GASTRO-2
- Status last verified
- Dec 2013
- First submitted
- 7 May 2012
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manno M, Pigo F, Manta R, Barbera C, Bertani H, Mirante VG, Dabizzi E, Caruso A, Olivetti G, Hassan C, Zullo A, Conigliaro R. Bowel preparation with polyethylene glycol electrolyte solution: optimizing the splitting regimen. Dig Liver Dis. 2012 Jul;44(7):576-9. doi: 10.1016/j.dld.2012.02.012. Epub 2012 Mar 26.
PubMed 22456624Voiosu 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 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preparation Regimens for Colonoscopy
- ClinicalTrials.gov ID
- NCT01596686
- Acronym / sponsor ID
- COL-GASTRO-2
- Conditions
- Colonoscopy Preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 May 2012 (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.
The investigators intend to study the impact of two different preparation regimens for colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient tolerability.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium picosulphate and magnesium citrate (Picoprep) | Active comparator | Drug: one of two possible colon preparation regimens |
| polyethylene glycol (Fortrans) | Active comparator | Drug: one of two possible colon preparation regimens |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients undergoing colonoscopy
Key exclusion criteria (1 listed)
- patient refusal to sign informed consent
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 |
|---|---|---|
| one of two possible colon preparation regimensAlso: Fortrans, PicoprepPatients are randomized to receive one of the two different preparation regimens for colonoscopy usually employed in our unit, polyethylene glycol or sodium picosulphate and magnesium citrate | Drug | polyethylene glycol (Fortrans), sodium picosulphate and magnesium citrate (Picoprep) |
Primary outcome
colon preparation
Time frame: 24 h
the impact of colon preparation as assessed by the endoscopist (scale from 1 to 4, 1 representing the worst and 4 the best prepared colon) on the quality of the endoscopic examination
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 24 Dec 2013.
- Background: PubMed 22456624Manno M, Pigo F, Manta R, Barbera C, Bertani H, Mirante VG, Dabizzi E, Caruso A, Olivetti G, Hassan C, Zullo A, Conigliaro R. Bowel preparation with polyethylene glycol electrolyte solution: optimizing the splitting regimen. Dig Liver Dis. 2012 Jul;44(7):576-9. doi: 10.1016/j.dld.2012.02.012. Epub 2012 Mar 26.
- Results publication: 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.
Related trials for Colonoscopy Preparation
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Bowel Cleansing Prior to Clinical Procedures
Recruiting
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
Bowel Preparation Before Colonoscopy
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one of two possible colon preparation regimens in people with Colonoscopy Preparation, run by Clinical Hospital Colentina at 2 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 1 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 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
colon preparation (time frame: 24 h). 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 NCT01596686, which also lists 2 linked publications.
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 24 Dec 2013.