Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)

Overall Status

Unknown status

CT.gov ID

NCT04153084

Collaborator

(none)

126

Enrollment

Locations

Anticipated Duration (Months)

15.8

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Digestive Illness	Drug: Polyethylene Glycol 4000 with electrolytes Drug: PEG-3350 with electrolytes Drug: Sodium picosulfate

Study Design

Study Type:

Observational

Anticipated Enrollment :

126 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Dec 15, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	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®

Arm

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®

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

1 Year to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Puerta del Mar	Cadiz	Cádiz	Spain	41019
2	Complejo Hospitalario Torrecárdenas	Almería		Spain	04009
3	Hospital Materno-Infantil de Badajoz	Badajoz		Spain	06010
4	Hospital Universitario Reina Sofía	Córdoba		Spain	14004
5	Hospital Universitario Virgen de las Nieves	Granada		Spain	18014
6	Hospital Universitario Virgen Macarena	Sevilla		Spain	41009
7	Hospital Universitario Virgen del Rocío	Sevilla		Spain	41013
8	Instituto Hispalense de Pediatría	Sevilla		Spain	41013