Capsule Endoscopy Clinical Trial
— PREP-CEOfficial title:
SMALL BOWEL CLEANSING FOR CAPSULE ENDOSCOPY IN PEDIATRIC PATIENTS: A PROSPECTIVE RANDOMIZED SINGLE-BLINDED STUDY
Verified date | November 2005 |
Source | Azienda Policlinico Umberto I |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 18 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)
Country | Name | City | State |
---|---|---|---|
Italy | Departments of Pediatrics, Sapienza - University of Rome | Rome |
Lead Sponsor | Collaborator |
---|---|
Azienda Policlinico Umberto I |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
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