Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy

NCT04153084 — Unknown, 126 participants, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Comparative Study of Effectiveness and Safety of Different Endoscopic Preparations Used in Pediatric Colonoscopy

RegistryNCT04153084
StatusUnknown
Study typeObservational
Enrollment126 (Estimated)
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)
ConditionsDigestive Illness
InterventionsPolyethylene Glycol 4000 with electrolytes, PEG-3350 with electrolytes, Sodium picosulfate (Drug)
Datesstart 2018-10-01, primary completion 2019-12-15 (estimated), completion 2019-12-31 (estimated), first posted 2019-11-06, last updated 2019-11-08
Locations8 sites in Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Digestive Illness All trials of Polyethylene Glycol 4000 with electrolytes All trials of PEG-3350 with electrolytes

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
High volume electrolytes Polyethylene Glycol (PEG 4000) cohortDrug: 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) cohortDrug: 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 cohortDrug: 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.
  • Polyethylene Glycol 4000 with electrolytes (Drug), also known as 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 electrolytes (Drug), also known as 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 picosulfate (Drug), also known as 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.

+Outcome measures

Primary outcomes

  • Evaluate the quality of the colonoscopy preparations in our autonomic community comparing different preparation guidelines : Boston Scale [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.

Secondary outcomes

  • Evaluate the acceptance of the different preparations. [From November 2018 to December 2019]: 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.
  • Evaluate the tolerance of the different preparations. [From November 2018 to December 2019]: 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.
  • Evaluate the security of the different preparations. [From November 2018 to December 2019]: The security will be measured analysing the existence of adverse effects due to the different preparations.

+Eligibility

Sex: All, ages: 1 Year to 16 Years

Inclusion Criteria:

* From 1 to 16 years old.
* Patients that signed the informed consent form.

Exclusion Criteria:

* Urgent colonoscopy
* History of intestinal resection
* Nephropathy, heart disease or metabolic syndrome.

+Locations (8)

FacilityCityCountryStatus
Hospital Universitario Puerta del MarCadiz, CádizSpainNot yet recruiting
Complejo Hospitalario TorrecárdenasAlmeríaSpainNot yet recruiting
Hospital Materno-Infantil de BadajozBadajozSpainNot yet recruiting
Hospital Universitario Reina SofíaCórdobaSpainNot yet recruiting
Hospital Universitario Virgen de las NievesGranadaSpainNot yet recruiting
Hospital Universitario Virgen MacarenaSevilleSpainRecruiting
Hospital Universitario Virgen del RocíoSevilleSpainRecruiting
Instituto Hispalense de PediatríaSevilleSpainNot yet recruiting

+Investigators

  • Alejandro Rodríguez Martínez, Principal investigator, Hospital Universitario Virgen Rocío