Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy

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.

Study Overview

• Status: Unknown
• Conditions: Digestive Illness
• Intervention / Treatment: Drug: Polyethylene Glycol 4000 with electrolytes; Drug: PEG-3350 with electrolytes; Drug: Sodium picosulfate

• Study Type: Observational
• Enrollment (Anticipated): 126

Contacts and Locations

Study Locations

• Spain
  • Almería, Spain, 04009
    • Not yet recruiting
    • Complejo Hospitalario Torrecárdenas
    • Contact: Rafael Galera Martínez
  • Badajoz, Spain, 06010
    • Not yet recruiting
    • Hospital Materno-Infantil de Badajoz
    • Contact: Ana María Márquez Armenteros
  • Córdoba, Spain, 14004
    • Not yet recruiting
    • Hospital Universitario Reina Sofia
    • Contact: Rafael González de Caldas Marchal
  • Granada, Spain, 18014
    • Not yet recruiting
    • Hospital Universitario Virgen de las Nieves
    • Contact: María Medina Gil
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
    • Contact: Carmen Cuadrado Caballero
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
    • Contact: Alejandro Rodríguez Martínez
  • Sevilla, Spain, 41013
    • Not yet recruiting
    • Instituto Hispalense de Pediatria
    • Contact: Joaquín Reyes Andrade
  • Cádiz
    • Cadiz, Cádiz, Spain, 41019
      • Not yet recruiting
      • Hospital Universitario Puerta del Mar
      • Contact: Cristina Pérez Aragón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Polyethylene Glycol 4000 with electrolytes; The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.; Other Names: Bohm solution®
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.	Drug: PEG-3350 with electrolytes; The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.; Other Names: Movicol®
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.	Drug: Sodium picosulfate; 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.; Other Names: Picoprep®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From November 2018 to December 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From November 2018 to December 2019

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Principal Investigator: Alejandro Rodríguez Martínez, Hospital Universitario Virgen Rocio

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ANTICIPATED): December 15, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (ACTUAL): November 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: PEG; Picoprep; Sodium picosulfate; Pediatric colonoscopy; Endoscopic preparations; Bohm solution; Movicol; Colonoscopic examination
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Picosulfate sodium; Polyethylene glycol 3350
• Other Study ID Numbers: FIS-POL-2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No