Colorectal Polyps Clinical Trial
Official title:
Free-residue Nutrients for the Bowel Preparation of Colon Capsule Endoscopy
Verified date | February 2017 |
Source | Xijing Hospital of Digestive Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Colon capsule endoscopy(CCE) is a new diagnostic method of colonic lesions.It has advantages of no requirement for sedation and air insufflation.The bowel preparation has a closely relationship with yield of diagnosing diseases.Bowel preparation of CCE is not only to clean the colon but also to promote capsule propulsion.Now there is not an optimal method for CCE.
Status | Active, not recruiting |
Enrollment | 62 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 18-80 years of age. - underwent a diagnostic OC that demonstrated colorectal polyps that required endoscopic treatment. Exclusion Criteria: 1. dysphagia/swallowing disorder 2. prior major abdominal surgery of the gastrointestinal tract, known or suspected bowel obstruction 3. cardiac pacemaker/implanted electromedical device 4. pregnant or nursing women 5. any allergy or contraindication to the drugs used in the study. 6. refused to sign a informed consent. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Kaichun Wu |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bowel Cleansing Level of Two Different Bowel Preparation Methods | The first 32 patients adopted a low fiber diet two days before the CCE procedure. Bowel preparation included the ingestion of 2L polyethyleneglycol in the evening before test day and 2L PEG in the morning on the test day. The subsequent 30 patients were received free-residue Nutrients?Then they ingested 2L PEG between 5:00 and 7.00 am of the examination day. The capsule was scheduled at 8:30 am. When the capsule reached the small bowel, 0.75L PEG was used as first booster. If the capsule had not been excreted 3 hours later, the patients was received 0.5L PEG. | an expected average of 1 months from study procedure | |
Secondary | Accuracy parameters:assessment the yield of detection of polyps =6mm and =10mm; | an expected average of 1 months from study procedure | ||
Secondary | The gastrointestinal tract transit times and the colonic transit times between two different bowel preparation methods for CCE; | The gastrointestinal tract transit time was defined as the time from initial ingestion to capsule excretion. The colon transit time defined as first capsule image of the cecum to capsule excretion. | an expected average of 1 months from study procedure | |
Secondary | Colon capsule excretion rate between two different bowel preparation methods; | an expected average of 1 months from study procedure | ||
Secondary | Adverse events between two different bowel preparation methods. | the PillCam procedure day |
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