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

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

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.

Study Overview

• Status: Unknown
• Conditions: Capsule Endoscopy
• Intervention / Treatment: Behavioral: DIET; Drug: polyethylene glycol 4000 solution with simethicon; Drug: simethicon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00161
    • Recruiting
    • Departments of Pediatrics, Sapienza - University of Rome
    • Contact: Giovanni Di Nardo, MD; Phone Number: +390649979326; Email: giovanni.dinardo@uniroma1.it
    • Principal Investigator: Giovanni Di Nardo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: DIET; clear liquid diet for 12 hours on the day before CE, followed by an overnight fast
Experimental: 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.	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; Other Names: selg-esse
Experimental: 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.	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; Other Names: selg-esse
Experimental: 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.	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; Other Names: Panamir V
Experimental: 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.	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; Other Names: selg-esse; 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; Other Names: Panamir V

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Preparation efficacy was evaluated by the blinded endoscopist according to a visibility score. There is no standardized or validated scoring system for the quality of small-bowel cleanliness. The visibility of the mucosal surface was assessed as the percentage of visualized bowel surface area as follows: 1: < 25%; 2: 25%-49%; 3: 50%-74%; 4: 75%-89%; 5: > 90%.	During the performance of capsule endoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	the number of positive findings and the overall diagnostic yield. A positive finding was defined as the presence of a visible finding, whether incidental or clinically relevant. A positive yield at CE was assumed if the visible finding was considered relevant to the indication for CE. Where appropriate, this was confirmed by further evaluation (repeated upper-GI or lower-GI endoscopy, single-balloon enteroscopy (SBE), laparotomy, or cross-sectional imaging).	during the reading capsule endoscopy
Safety	Adverse events were assessed on the day of capsule endoscopy by direct questioning and by telephone interview 48-96 hours after capsule endoscopy.	4 days
clinical tolerabiity	Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort. All patients were tested with a questionnaire, based on a numerical scale between 0 and 10 (with 10 being no burden at all and 0 indicating an intolerable procedure), about the impact of the bowel preparation (Van Tuyl Endoscopy 2007) and their level of satisfaction.	On the morning of colonoscopy, immediately before the procedure

Collaborators and Investigators

• Sponsor: Azienda Policlinico Umberto I

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: February 4, 2013
• First Posted (Estimate): February 5, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Keywords: children; Capsule Endoscopy; colon cleansing; age 2 -18 years
• Other Study ID Numbers: CLEANSING FOR PED-CE