Bowel PreparationNCT02536729
Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome
An observational study of Bowel Preparation, run by Fundación Salutia.
Trial summary
Objective: The primary objective of this study is to assess the quality of life of people treated with oral phosphate compared with polyethylene glycol + electrolytes to imaging procedures, according to the outcome variables reported by patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Oral Sodium Phosphate - Normal preparation, Oral sodium phosphate - Modified Preparation and polyethylene glycol + Electrolytes
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jun 2016
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who are in diagnostic centers, which have order for an imaging procedure that requires intestinal cleansing conducted.
Who may be able to join
- Patients which have order for an imaging procedure that requires bowel cleansing
- Older than 18 years and younger than 65 years old
- Accept to participate in this study
Who cannot join
None listed.
About this study
Objective: The primary objective of this study is to assess the quality of life of people treated with oral phosphate compared with polyethylene glycol + electrolytes to imaging procedures, according to the outcome variables reported by patients.
Type of study: A non-interventional observational analytic prospective cohort study.
Read more
Sample: We will include people who need bowel cleansing for the realization of imaging tests
Exposures: - oral sodium phosphate normal regimen
- Oral sodium phosphate with modified diet
- Polyethylene Glycol + electrolytes
Follow-up time: 8 days after the bowel preparation
Outcomes: Boston Scale measure Safety Differences between groups in blood test (Sodium, Potassium, Calcium)
- Conditions
- Bowel Preparation
- Being tested
- Oral Sodium Phosphate - Normal preparation, Oral sodium phosphate - Modified Preparation, polyethylene glycol + Electrolytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Sodium Phosphate - Normal preparationDrug
Also called Travad
Oral sodium phosphate - Modified PreparationDrug
Also called Travad
polyethylene glycol + ElectrolytesDrug
Also called PEG
| Study group | Role | What they receive |
|---|---|---|
| Oral Sodium Phosphate - Normal preparation | Oral sodium phospate exposure with special diet (Liquid) Receives: Drug: Oral Sodium Phosphate - Normal preparation | |
| Oral Sodium Phosphate - Modified preparation | Oral sodium phospate exposure with special diet (Liquid), but the participant can normally lunch the day before the test Receives: Drug: Oral sodium phosphate - Modified Preparation | |
| polyethylene glycol + Electrolytes | polyethylene glycol + Electrolytes exosure with special diet (Liquid) Receives: Drug: polyethylene glycol + Electrolytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston scale for bowel cleansing
Measured: 2 days
Secondary outcomes (8)
Number of adverse events
Measured: 8 days
Quality of life
Quality of life measured with EQ5D-3L scale
Measured: 8 days
Blood creatinine
Measured: 8 days
Blood urea nitrogen (BUN)
Measured: 8 days
Blood Sodium
Measured: 8 days
Blood Potassium
Measured: 8 days
Blood Calcium
Measured: 8 days
Blood Phosphorus
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Salutia
- Sponsor type
- University, hospital or other
- Collaborators
- Tecnoquimicas S.A
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536729
- Sponsor's protocol ID
- TRAVAD2015
- Status last verified
- Aug 2015
- First submitted
- 27 Aug 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome
- ClinicalTrials.gov ID
- NCT02536729
- Acronym / sponsor ID
- TRAVAD2015
- Conditions
- Bowel Preparation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fundación SalutiaUniversity, hospital or other
- Collaborators
- Tecnoquimicas S.A
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (estimated)
- First posted
- 1 Sep 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.
Objective: The primary objective of this study is to assess the quality of life of people treated with oral phosphate compared with polyethylene glycol + electrolytes to imaging procedures, according to the outcome variables reported by patients.
Type of study: A non-interventional observational analytic prospective cohort study.
Sample: We will include people who need bowel cleansing for the realization of imaging tests
Exposures: - oral sodium phosphate normal regimen
- Oral sodium phosphate with modified diet
- Polyethylene Glycol + electrolytes
Follow-up time: 8 days after the bowel preparation
Outcomes: Boston Scale measure Safety Differences between groups in blood test (Sodium, Potassium, Calcium)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Sodium Phosphate - Normal preparation | – | Drug: Oral Sodium Phosphate - Normal preparationOral sodium phospate exposure with special diet (Liquid) |
| Oral Sodium Phosphate - Modified preparation | – | Drug: Oral sodium phosphate - Modified PreparationOral sodium phospate exposure with special diet (Liquid), but the participant can normally lunch the day before the test |
| polyethylene glycol + Electrolytes | – | Drug: polyethylene glycol + Electrolytespolyethylene glycol + Electrolytes exosure with special diet (Liquid) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who are in diagnostic centers, which have order for an imaging procedure that requires intestinal cleansing conducted.
Key inclusion criteria (3 listed)
- Patients which have order for an imaging procedure that requires bowel cleansing
- Older than 18 years and younger than 65 years old
- Accept to participate in this study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oral Sodium Phosphate - Normal preparationAlso: Travad | Drug | Oral Sodium Phosphate - Normal preparation |
| Oral sodium phosphate - Modified PreparationAlso: Travad | Drug | Oral Sodium Phosphate - Modified preparation |
| polyethylene glycol + ElectrolytesAlso: PEG | Drug | polyethylene glycol + Electrolytes |
Primary outcome
Boston scale for bowel cleansing
Time frame: 2 days
8 secondary outcomes
Number of adverse events
Time frame: 8 days
Quality of life
Time frame: 8 days
Blood creatinine
Time frame: 8 days
Blood urea nitrogen (BUN)
Time frame: 8 days
Blood Sodium
Time frame: 8 days
Blood Potassium
Time frame: 8 days
Blood Calcium
Time frame: 8 days
Blood Phosphorus
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Preparation, run by Fundación Salutia.
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 0 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: status not confirmed, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Boston scale for bowel cleansing (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 1 Sep 2015.