Clinical trial NCT02887573: Free-residue Nutrients for the Bowel Preparation of Colon Capsule Endoscopy
Official title: Free-residue Nutrients for the Bowel Preparation of Colon Capsule Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colorectal Polyps
Keywords: Bowel preparation
Colorectal polyps
Colon capsule endoscopy
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Objective: In this study, a new bowel preparation regime of the colon capsule is used.This regime combines free-residue nutrients and polyethylene glycol (PEG) to achieve a better preparation quality.

Methods: Participants who underwent a diagnostic colonoscopy examination that demonstrated a colorectal polyps that required endoscopic treatment will be recruited to patients in the study. The first 32 participants receive a traditional low fiber diet two days before the test.Then the patients will take 2L polyethylene glycol (PEG) at 21:00-23:00 before the test day and 2L PEG at 05:00-07:00 on the test day for bowel preparation. The subsequent 30 participants receive two-days free-residue nutrients without other diet before the test.Then the patients will take 2L PEG at 05:00-07:00 on the examination day for bowel preparation. Then they will take 5mg mosapride citrate at 8:00 and ingest the colon capsule at 8:30.0.75L and 0.50L PEG are administered as boosters.And the therapeutic endoscopy will be given on the following day.Before the therapeutic colonoscopy, the participants will take 2L PEG. The colon capsule results will be reviewed by two experienced endoscopists who are blinded to first endoscopy results.

Eligibility criteria: 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.

Primary outcomes:
measure: Bowel Cleansing Level of Two Different Bowel Preparation Methods
timeFrame: an expected average of 1 months from study procedure
Secondary outcomes:
measure: Accuracy parameters:assessment the yield of detection of polyps ≥6mm and ≥10mm;
timeFrame: an expected average of 1 months from study procedure
measure: The gastrointestinal tract transit times and the colonic transit times between two different bowel preparation methods for CCE;
timeFrame: an expected average of 1 months from study procedure
measure: Colon capsule excretion rate between two different bowel preparation methods;
timeFrame: an expected average of 1 months from study procedure
measure: Adverse events between two different bowel preparation methods.
timeFrame: the PillCam procedure day
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital of Digestive Diseases
name: Wu Kaichun, phD
role: STUDY_DIRECTOR
References: