Small Bowel Cleansing for Capsule Endoscopy in Pediatric Patients

NCT ID: NCT01783782

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2013-09-30

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.

Conditions

Capsule Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

DIET

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.

Group Type: EXPERIMENTAL

DIET

Intervention Type: BEHAVIORAL

clear liquid diet for 12 hours on the day before CE, followed by an overnight fast

HIGH PEG

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.

Group Type: EXPERIMENTAL

polyethylene glycol 4000 solution with simethicon

Intervention Type: DRUG

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

LOW PEG

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.

Group Type: EXPERIMENTAL

polyethylene glycol 4000 solution with simethicon

Intervention Type: DRUG

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

SIMETHICONE

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.

Group Type: EXPERIMENTAL

simethicon

Intervention Type: DRUG

Patients received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion

SIMETH+PEG

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.

Group Type: EXPERIMENTAL

polyethylene glycol 4000 solution with simethicon

Intervention Type: DRUG

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

simethicon

Intervention Type: DRUG

Patients received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion

Interventions

DIET

clear liquid diet for 12 hours on the day before CE, followed by an overnight fast

Intervention Type: BEHAVIORAL

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

selg-esse; Panamir V

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Policlinico Umberto I

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Di Nardo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Departments of Pediatrics, Sapienza - University of Rome

Rome, Rome, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giovanni Di Nardo, MD

Role: primary

giovanni.dinardo@uniroma1.it

+390649979326

Other Identifiers

CLEANSING FOR PED-CE

Identifier Type: -

Identifier Source: org_study_id