Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy

NCT04153084 | Unknown

• 1 other identifier: FIS-POL-2017-01
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Digestive Illness

Keywords

Pediatric colonoscopy; Endoscopic preparations; PEG; Sodium picosulfate; Bohm solution; Movicol; Picoprep; Colonoscopic examination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluate the acceptance of the different preparations.

  From November 2018 to December 2019

• Evaluate the tolerance of the different preparations.

  From November 2018 to December 2019

• Evaluate the security of the different preparations.

  From November 2018 to December 2019

Study Arms (3)

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

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

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

Interventions

Polyethylene Glycol 4000 with electrolytes DRUG

The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.

Also known as: Bohm solution®

High volume electrolytes Polyethylene Glycol (PEG 4000) cohort

PEG-3350 with electrolytes DRUG

The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.

Also known as: Movicol®

Low volume electrolytes PEG (PEG 3350) cohort

Sodium picosulfate DRUG

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.

Also known as: Picoprep®

Sodium picosulfate cohort

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (8)

Hospital Universitario Puerta del Mar

Cadiz, Cádiz, 41019, Spain

NOT YET RECRUITING

Complejo Hospitalario Torrecárdenas

Almería, 04009, Spain

NOT YET RECRUITING

Hospital Materno-Infantil de Badajoz

Badajoz, 06010, Spain

NOT YET RECRUITING

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

NOT YET RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

NOT YET RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Instituto Hispalense de Pediatría

Seville, 41013, Spain

NOT YET RECRUITING

MeSH Terms

Interventions

polyethylene glycol 4000; Electrolytes; polyethylene glycol 3350; picosulfate sodium

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Alejandro Rodríguez Martínez

  Hospital Universitario Virgen Rocío

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Rodríguez Martínez

CONTACT

955012000; alejandro.rodriguez.m.sspa@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: October 1, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 31, 2019
• Last Updated: November 8, 2019

Record last verified: 2019-09

Locations

ES (8)