NCT01783782

Small Bowel Cleansing for Capsule Endoscopy in Pediatric Patients

SMALL BOWEL CLEANSING FOR CAPSULE ENDOSCOPY IN PEDIATRIC PATIENTS: A PROSPECTIVE RANDOMIZED SINGLE-BLINDED STUDY

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Azienda Policlinico Umberto I · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Capsule Endoscopy

Interventions

Type	Name	Description
BEHAVIORAL	DIET	clear liquid diet for 12 hours on the day before CE, followed by an overnight fast
DRUG	polyethylene glycol 4000 solution with simethicon	patients received a high volume regime consisting of a 50 mL/Kg (up to 2 Lt/die) of PEG solution the evening before the examination, followed always by an overnight fast
DRUG	simethicon	Patients received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion

Timeline

• Start date: 2005-11-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2013-02-05
• Last updated: 2013-02-05

Locations

1 site across 1 country: Italy