Small Bowel Cleansing for Capsule Endoscopy in Pediatric Patients (PREP-CE)

A

Azienda Policlinico Umberto I

Status and phase

Unknown
Phase 4

Conditions

Capsule Endoscopy

Treatments

Drug: simethicon
Drug: polyethylene glycol 4000 solution with simethicon
Behavioral: DIET

Study type

Interventional

Funder types

Other

Identifiers

NCT01783782
CLEANSING FOR PED-CE

Details and patient eligibility

About

The primary aim of this prospective, randomized and controlled study was to evaluate the effect of five bowel preparation regimens on small-bowel cleansing in a pediatric population. The secondary endpoints were to evaluate the safety and the effects of preparation on diagnostic yield of CE.

Full description

Capsule endoscopy (CE) is a well-known, non-invasive, diagnostic tool to evaluate small bowel diseases in adults and children. Unfortunately, because CE does not have functions which allow suctioning of fluid or washing the small bowel mucosa during the examination, its diagnostic yield can be limited by presence of debris, biliary secretion, bubbles and blood in the gut lumen that may hide relevant findings especially in the distal small bowel. In addition, CE sometimes fails to reach the cecum within the battery life of the capsule, resulting in a failure to visualize the distal small intestine. However, in children this problem is less frequent for the increased intestinal motility, which reduces the transit time of the capsule. It was believed that cleaning the small intestine prior to examination would improve mucosal visibility during the endoscopy and, as a result, the diagnostic yield of the technique. Therefore, proposals were put forward based on preparations for other types of explorations, such as colonoscopies (2). Some authors have already studied in adults the effect of bowel preparation on small-bowel visualization using different agents; the results of the published series are contradictory. To date, while there is evidence for a benefit from bowel preparation for CE, there is so far no consensus on an optimal preparation regimen. In addition, in children there are not studies on this topic. Therefore, overnight fasting before the examination still remains the proposed preparation for capsule endoscopy.

Enrollment

200 estimated patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing elective Small Bowel capsule endoscopy in our Institution between 2 and 18 years of age were recruited for this study.

Exclusion criteria

  • intestinal obstruction,
  • suspicious impaired intestinal motility,
  • history of gastrointestinal surgery

Trial design

200 participants in 5 patient groups

DIET
Experimental group
Description:
Group A followed the standard regime consisting of a clear liquid diet for 12 hours on the day before CE, followed by an overnight fast.
Treatment:
Behavioral: DIET
HIGH PEG
Experimental group
Description:
Group B received a high volume regime consisting of a 50 mL/Kg (up to 2 Lt/die) of polyethylene glycol 4000 solution with simethicon solution the evening before the examination, followed always by an overnight fast.
Treatment:
Drug: polyethylene glycol 4000 solution with simethicon
LOW PEG
Experimental group
Description:
Group C, defined as a low volume regime, received 25 mL/Kg (up to 1Lt/die) of polyethylene glycol 4000 solution with simethicon solution the evening before the examination, followed by an overnight fast.
Treatment:
Drug: polyethylene glycol 4000 solution with simethicon
SIMETHICONE
Experimental group
Description:
Group D received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion.
Treatment:
Drug: simethicon
SIMETH+PEG
Experimental group
Description:
Group E received 25 mL/Kg (up to 1 Lt/die) of polyethylene glycol 4000 solution with simethicon solution followed by an overnight fast plus 20mL oral simethicone and 200mL water 30 minutes before capsule ingestion.
Treatment:
Drug: polyethylene glycol 4000 solution with simethicon
Drug: simethicon

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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