Cathartic ColonDIETSANNCT02371655
Different Bowel Preparations in CT Colonography: is Diet Necessary? A Randomized Controlled Trial
A study testing Diet, Faecal Tagging and Bowel cleansing in people with Cathartic Colon and Colonic Neoplasms, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cathartic Colon, Colonic Neoplasms
- What is being tested?
- Diet, Faecal Tagging and Bowel cleansing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2015to 1 Dec 2016
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic patients (Screening Patients)
- Symptomatic patients unwilling to undergo optical colonoscopy (Symptomatic Patients)
- Patients with a previous incomplete optical colonoscopy.
Who cannot join
- Allergy to Macrogol
- Cognitive behavioral deficits
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet.
Read the detailed description
Bowel preparation should be safe and well tolerated by patients, particularly in a screening setting. For this reason, limited bowel preparations have been extensively investigated. Usually, they combine the use of low-fibre diet and faecal/fluid tagging. The ingestion of a positive contrast agent (either barium, iodine or a combination of the two),needed to differentiate stool or fluid residues from true colonic lesions, is now considered mandatory. A low-fibre diet has the aim of improving residue homogeneity and facilitates tagging; however, there aren't significative evidences at support. The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet. Primary outcome is the overall quality of bowel preparation.
- Conditions
- Cathartic Colon, Colonic Neoplasms
- Being tested
- Diet, Faecal Tagging, Bowel cleansing, CT colonography
- Keywords
- Bowel cleansing, CTcolonography, Bowel preparation, Faecal and fluid tagging
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietProcedure or surgery
Also called diet included
A low-fibre diet for three days before the examination
Faecal TaggingDrug
Also called iodinated contrast media (oral)
Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination
Bowel cleansingDrug
Also called chatartic bowel preparation
Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination
CT colonographyProcedure or surgery
Also called Virtual colonoscopy
CT Examination of the colon aimed to detect polyps and cancer
| Study group | Role | What they receive |
|---|---|---|
| Diet included | Active comparator | Diet is included in bowel preparation Receives: Procedure: Diet; Drug: Faecal Tagging; Drug: Bowel cleansing; Procedure: CT colonography |
| Diet not included | Experimental | Diet is not included in bowel preparation Receives: Drug: Faecal Tagging; Drug: Bowel cleansing; Procedure: CT colonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall quality of bowel preparation using a 0-3 scale for each parameter (Homogeneity of solid-fluid fecal tagging, volume of residual fluid, colon distension).
the evaluation of overall quality of bowel preparation on CT colonography images including: homogeneity of tagging, presence of unmarked solid stool residues, the evaluation of volume of residual fluids and colon distention.
Measured: 1 day
Secondary outcomes (1)
compliance of patients
A 0-10 visual analogical scale (VAS) was used with 0 corresponding to no discomfort and 10 to severe discomfort with severe impact on patient's daily activities. Intermediate values corresponded to intermediate values of tolerance.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study start1 Oct 2015
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
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 Cathartic ColonStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Bellini, University of Roma La Sapienza
- Investigators
- Laghi Andrea, Professor, Study director, University of Rome "Sapienza" Faculty of Medicine and Dentistry Department of Radiological Sciences, Oncology and Pathology I.C.O.T. - Via F. Faggiana 34, 04100 Latina, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371655
- Sponsor's protocol ID
- URomLSDBAL1
- Acronym
- DIETSAN
- Status last verified
- May 2017
- First submitted
- 19 Feb 2015
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Liedenbaum MH, Denters MJ, de Vries AH, van Ravesteijn VF, Bipat S, Vos FM, Dekker E, Stoker J. Low-fiber diet in limited bowel preparation for CT colonography: Influence on image quality and patient acceptance. AJR Am J Roentgenol. 2010 Jul;195(1):W31-7. doi: 10.2214/AJR.09.3572.
PubMed 20566777Iafrate F, Iannitti M, Ciolina M, Baldassari P, Pichi A, Laghi A. Bowel cleansing before CT colonography: comparison between two minimal-preparation regimens. Eur Radiol. 2015 Jan;25(1):203-10. doi: 10.1007/s00330-014-3345-0. Epub 2014 Aug 23.
PubMed 25149295
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Bowel Preparations in CT Colonography: is Diet Necessary? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02371655
- Acronym / sponsor ID
- DIETSAN / URomLSDBAL1
- Conditions
- Cathartic Colon, Colonic Neoplasms
- Keywords
- Bowel cleansing, CTcolonography, Bowel preparation, Faecal and fluid tagging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 25 Feb 2015 (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 aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet.
Detailed description
Bowel preparation should be safe and well tolerated by patients, particularly in a screening setting. For this reason, limited bowel preparations have been extensively investigated. Usually, they combine the use of low-fibre diet and faecal/fluid tagging. The ingestion of a positive contrast agent (either barium, iodine or a combination of the two),needed to differentiate stool or fluid residues from true colonic lesions, is now considered mandatory. A low-fibre diet has the aim of improving residue homogeneity and facilitates tagging; however, there aren't significative evidences at support. The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet. Primary outcome is the overall quality of bowel preparation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet included | Active comparator | Procedure: Diet, Drug: Faecal Tagging, Drug: Bowel cleansing, Procedure: CT colonographyDiet is included in bowel preparation |
| Diet not included | Experimental | Drug: Faecal Tagging, Drug: Bowel cleansing, Procedure: CT colonographyDiet is not included in bowel preparation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Asymptomatic patients (Screening Patients)
- Symptomatic patients unwilling to undergo optical colonoscopy (Symptomatic Patients)
- Patients with a previous incomplete optical colonoscopy.
Key exclusion criteria (2 listed)
- Allergy to Macrogol
- Cognitive behavioral deficits
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 |
|---|---|---|
| DietAlso: diet includedA low-fibre diet for three days before the examination | Procedure or surgery | Diet included |
| Faecal TaggingAlso: iodinated contrast media (oral)Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination | Drug | Diet included, Diet not included |
| Bowel cleansingAlso: chatartic bowel preparationOral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination | Drug | Diet included, Diet not included |
| CT colonographyAlso: Virtual colonoscopyCT Examination of the colon aimed to detect polyps and cancer | Procedure or surgery | Diet included, Diet not included |
Primary outcome
overall quality of bowel preparation using a 0-3 scale for each parameter (Homogeneity of solid-fluid fecal tagging, volume of residual fluid, colon distension).
Time frame: 1 day
the evaluation of overall quality of bowel preparation on CT colonography images including: homogeneity of tagging, presence of unmarked solid stool residues, the evaluation of volume of residual fluids and colon distention.
1 secondary outcome
compliance of patients
Time frame: 1 day
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 12 May 2017.
- Background: PubMed 20566777Liedenbaum MH, Denters MJ, de Vries AH, van Ravesteijn VF, Bipat S, Vos FM, Dekker E, Stoker J. Low-fiber diet in limited bowel preparation for CT colonography: Influence on image quality and patient acceptance. AJR Am J Roentgenol. 2010 Jul;195(1):W31-7. doi: 10.2214/AJR.09.3572.
- Background: PubMed 25149295Iafrate F, Iannitti M, Ciolina M, Baldassari P, Pichi A, Laghi A. Bowel cleansing before CT colonography: comparison between two minimal-preparation regimens. Eur Radiol. 2015 Jan;25(1):203-10. doi: 10.1007/s00330-014-3345-0. Epub 2014 Aug 23.
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.
Laghi Andrea, Professor study director
University of Rome "Sapienza" Faculty of Medicine and Dentistry Department of Radiological Sciences, Oncology and Pathology I.C.O.T. - Via F. Faggiana 34, 04100 Latina, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Faecal Tagging and Bowel cleansing in people with Cathartic Colon and Colonic Neoplasms, run by University of Roma La Sapienza 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 3 inclusion and 2 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 12 May 2017. 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?
overall quality of bowel preparation using a 0-3 scale for each parameter (Homogeneity of solid-fluid fecal tagging, volume of residual fluid, colon distension). (time frame: 1 day). 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 NCT02371655, 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 12 May 2017.