Digestive IllnessNCT04153084
Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy
An observational study of Digestive Illness, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 8 sites in Spain.
Trial summary
The aim of this study is to evaluate the quality, acceptance, tolerability and adverse effects of colonoscopy preparations with the different available preparation guidelines. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Digestive Illness
- What is being tested?
- Polyethylene Glycol 4000 with electrolytes, PEG-3350 with electrolytes and Sodium picosulfate
- How many people
- 126 participants
- Where
- 8 sitesSpain
- Study dates
- 1 Oct 2018to 31 Dec 2019
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients who have undergone a colonoscopic exploration during the years 2018-2019, as part of a diagnostic process not related to the study.
Who may be able to join
- From 1 to 16 years old.
- Patients that signed the informed consent form.
Who cannot join
- Urgent colonoscopy
- History of intestinal resection
- Nephropathy, heart disease or metabolic syndrome.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites, 8 recruiting
- Not yet recruiting
Complejo Hospitalario Torrecárdenas
Almería, 04009
Rafael Galera Martínez
- Not yet recruiting
Hospital Materno-Infantil de Badajoz
Badajoz, 06010
Ana María Márquez Armenteros
- Not yet recruiting
Hospital Universitario Puerta del Mar
Cadiz, Cádiz, 41019
Cristina Pérez Aragón
- Not yet recruiting
Hospital Universitario Reina Sofía
Córdoba, 14004
Rafael González de Caldas Marchal
- Not yet recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
María Medina Gil
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Carmen Cuadrado Caballero
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
Alejandro Rodríguez Martínez
- Not yet recruiting
Instituto Hispalense de Pediatría
Seville, 41013
Joaquín Reyes Andrade
About this study
Official title: Comparative Study of Effectiveness and Safety of Different Endoscopic Preparations Used in Pediatric Colonoscopy
The aim of this study is to evaluate the quality, acceptance, tolerability and adverse effects of colonoscopy preparations with the different available preparation guidelines.
- Conditions
- Digestive Illness
- Being tested
- Polyethylene Glycol 4000 with electrolytes, PEG-3350 with electrolytes, Sodium picosulfate
- Keywords
- Pediatric colonoscopy, Endoscopic preparations, PEG, Sodium picosulfate, Bohm solution, Movicol, Picoprep, Colonoscopic examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol 4000 with electrolytesDrug
Also called Bohm solution®
The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
PEG-3350 with electrolytesDrug
Also called Movicol®
The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
Sodium picosulfateDrug
Also called Picoprep®
The Sodium picosulfate will be administered the day before the procedure at different doses depending on the patient´s age:
- From 1 to 2 years old: ¼ sachet reconstituted in ¼ glass of water/juice in the afternoon (15:00 h) and ¼ sachet reconstituted in ¼ glass of water/juice 6 hours later (21:00 h)
- From 2 to 4 years old: ½ sachet in ½ glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night.
- From 4 to 9 years old: 1 sachet in 1 glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night.
- Of 9 years old and older: 1 sachet in the afternoon and 1 sachet at night.
| Study group | Role | What they receive |
|---|---|---|
| High volume electrolytes Polyethylene Glycol (PEG 4000) cohort | Pediatric patients who have prepared for a colonoscopy during the years 2018-2019 using high volume electrolytes PEG (Bohm solution®) endoscopic preparation, as part of a diagnostic procedure not related to this study. Receives: Drug: Polyethylene Glycol 4000 with electrolytes | |
| Low volume electrolytes PEG (PEG 3350) cohort | Pediatric patients who have prepared for a colonoscopy during the years 2018-2019 using low volume electrolytes PEG (Movicol®) endoscopic preparation, as part of a diagnostic procedure not related to this study. Receives: Drug: PEG-3350 with electrolytes | |
| Sodium picosulfate cohort | Pediatric patients who have prepared for a colonoscopy during the years 2018-2019 using sodium picosulfate (Picoprep®) endoscopic preparation, as part of a diagnostic procedure not related to this study. Receives: Drug: Sodium picosulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the quality of the colonoscopy preparations in our autonomic community comparing different preparation guidelines : Boston Scale
The quality of the preparations will be measured using the Boston Bowel Preparation Scale (BBPS), semiquantitative evaluation of the cleanliness of the three colon sections (left, transverse, right) using a score from 0 to 3, giving a total score of 0 (without preparation) to 9 (optimal) and it´s done by two independent observers.
Measured: From November 2018 to December 2019
Secondary outcomes (3)
Evaluate the acceptance of the different preparations.
The acceptance will be measured using a questionnaire and a quantity record, the questonnaire is made by three items: flavour, odour and volume while the quantity record measures the quantity of preparation ingested by the participant.
Measured: From November 2018 to December 2019
Evaluate the tolerance of the different preparations.
The tolerance will be measured using a questionnaire and a symptoms record, with a score from 0 (terrible tolerance) to 3 (good tolerance) for each of its items, that are the following: abdominal pain, nausea and vomit, intestinal noises, abdominal distension, burps, flatulences, urgent bowel movements and tenesmus.
Measured: From November 2018 to December 2019
Evaluate the security of the different preparations.
The security will be measured analysing the existence of adverse effects due to the different preparations.
Measured: From November 2018 to December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Oct 2018
- Primary completion15 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive IllnessStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Rodríguez Martínez, Principal investigator, Hospital Universitario Virgen Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153084
- Sponsor's protocol ID
- FIS-POL-2017-01
- Status last verified
- Sep 2019
- First submitted
- 4 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Effectiveness and Safety of Different Endoscopic Preparations Used in Pediatric Colonoscopy
- ClinicalTrials.gov ID
- NCT04153084
- Acronym / sponsor ID
- FIS-POL-2017-01
- Conditions
- Digestive Illness
- Keywords
- Pediatric colonoscopy, Endoscopic preparations, PEG, Sodium picosulfate, Bohm solution, Movicol, Picoprep, Colonoscopic examination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Nov 2019 (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 aim of this study is to evaluate the quality, acceptance, tolerability and adverse effects of colonoscopy preparations with the different available preparation guidelines.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High volume electrolytes Polyethylene Glycol (PEG 4000) cohort | – | Drug: Polyethylene Glycol 4000 with electrolytesPediatric patients who have prepared for a colonoscopy during the years 2018-2019 using high volume electrolytes PEG (Bohm solution®) endoscopic preparation, as part of a diagnostic procedure not related to this study. |
| Low volume electrolytes PEG (PEG 3350) cohort | – | Drug: PEG-3350 with electrolytesPediatric patients who have prepared for a colonoscopy during the years 2018-2019 using low volume electrolytes PEG (Movicol®) endoscopic preparation, as part of a diagnostic procedure not related to this study. |
| Sodium picosulfate cohort | – | Drug: Sodium picosulfatePediatric patients who have prepared for a colonoscopy during the years 2018-2019 using sodium picosulfate (Picoprep®) endoscopic preparation, as part of a diagnostic procedure not related to this study. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients who have undergone a colonoscopic exploration during the years 2018-2019, as part of a diagnostic process not related to the study.
Key inclusion criteria (2 listed)
- From 1 to 16 years old.
- Patients that signed the informed consent form.
Key exclusion criteria (3 listed)
- Urgent colonoscopy
- History of intestinal resection
- Nephropathy, heart disease or metabolic syndrome.
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 |
|---|---|---|
| Polyethylene Glycol 4000 with electrolytesAlso: Bohm solution®The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours. | Drug | High volume electrolytes Polyethylene Glycol (PEG 4000) cohort |
| PEG-3350 with electrolytesAlso: Movicol®The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours. | Drug | Low volume electrolytes PEG (PEG 3350) cohort |
| Sodium picosulfateAlso: Picoprep®The Sodium picosulfate will be administered the day before the procedure at different doses depending on the patient´s age: * From 1 to 2 years old: ¼ sachet reconstituted in ¼ glass of water/juice in the afternoon (15:00 h) and ¼ sachet reconstituted in ¼ glass of water/juice 6 hours later (21:00 h) * From 2 to 4 years old: ½ sachet in ½ glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night. * From 4 to 9 years old: 1 sachet in 1 glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night. * Of 9 years old and older: 1 sachet in the afternoon and 1 sachet at night. | Drug | Sodium picosulfate cohort |
Primary outcome
Evaluate the quality of the colonoscopy preparations in our autonomic community comparing different preparation guidelines : Boston Scale
Time frame: From November 2018 to December 2019
The quality of the preparations will be measured using the Boston Bowel Preparation Scale (BBPS), semiquantitative evaluation of the cleanliness of the three colon sections (left, transverse, right) using a score from 0 to 3, giving a total score of 0 (without preparation) to 9 (optimal) and it´s done by two independent observers.
3 secondary outcomes
Evaluate the acceptance of the different preparations.
Time frame: From November 2018 to December 2019
Evaluate the tolerance of the different preparations.
Time frame: From November 2018 to December 2019
Evaluate the security of the different preparations.
Time frame: From November 2018 to December 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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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.
Alejandro Rodríguez Martínez principal investigator
Hospital Universitario Virgen Rocío
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive Illness, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 8 sites in Spain.
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 2 inclusion and 3 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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Rodríguez Martínez (955012000, alejandro.rodriguez.m.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the quality of the colonoscopy preparations in our autonomic community comparing different preparation guidelines : Boston Scale (time frame: From November 2018 to December 2019). 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 8 Nov 2019.