Clinical trial NCT01783782: Small Bowel Cleansing for Capsule Endoscopy in Pediatric Patients
Official title: SMALL BOWEL CLEANSING FOR CAPSULE ENDOSCOPY IN PEDIATRIC PATIENTS: A PROSPECTIVE RANDOMIZED SINGLE-BLINDED STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Capsule Endoscopy
Keywords: Capsule Endoscopy
colon cleansing
children
age 2 -18 years
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy
timeFrame: During the performance of capsule endoscopy
Secondary outcomes:
measure: Efficacy
timeFrame: during the reading capsule endoscopy
measure: Safety
timeFrame: 4 days
measure: clinical tolerabiity
timeFrame: On the morning of colonoscopy, immediately before the procedure
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Departments of Pediatrics, Sapienza - University of Rome
Study officials:
References: