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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Azienda Policlinico Umberto I.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Giovanni Di Nardo, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:
NCT01783782
First received: February 1, 2013
Last updated: February 4, 2013
Last verified: November 2005
  Purpose

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.


Condition Intervention Phase
Capsule Endoscopy
Behavioral: DIET
Drug: polyethylene glycol 4000 solution with simethicon
Drug: simethicon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: SMALL BOWEL CLEANSING FOR CAPSULE ENDOSCOPY IN PEDIATRIC PATIENTS: A PROSPECTIVE RANDOMIZED SINGLE-BLINDED STUDY

Resource links provided by NLM:


Further study details as provided by Azienda Policlinico Umberto I:

Primary Outcome Measures:
  • Efficacy [ Time Frame: During the performance of capsule endoscopy ] [ Designated as safety issue: No ]

    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%.



Secondary Outcome Measures:
  • Efficacy [ Time Frame: during the reading capsule endoscopy ] [ Designated as safety issue: No ]

    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).


  • Safety [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    Adverse events were assessed on the day of capsule endoscopy by direct questioning and by telephone interview 48-96 hours after capsule endoscopy.

  • clinical tolerabiity [ Time Frame: On the morning of colonoscopy, immediately before the procedure ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 200
Study Start Date: November 2005
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Panamir V

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

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783782

Locations
Italy
Departments of Pediatrics, Sapienza - University of Rome Recruiting
Rome, Italy, 00161
Contact: Giovanni Di Nardo, MD    +390649979326    giovanni.dinardo@uniroma1.it   
Principal Investigator: Giovanni Di Nardo, MD         
Sponsors and Collaborators
Azienda Policlinico Umberto I
  More Information

No publications provided

Responsible Party: Giovanni Di Nardo, MD, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT01783782     History of Changes
Other Study ID Numbers: CLEANSING FOR PED-CE
Study First Received: February 1, 2013
Last Updated: February 4, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Policlinico Umberto I:
Capsule Endoscopy
colon cleansing
children
age 2 -18 years

Additional relevant MeSH terms:
Simethicone
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014