Small Bowel Disease
Conditions
Keywords
capsule endoscopy, polyethylene glycol, bowel preparation solutions
Brief summary
The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in patients referred for CE examination.
Interventions
DRUGpolyethylene glycol
DEVICEcapsule endoscopy
Sponsors
Huashan Hospital
Shanghai East Hospital
Shanghai Tong Ren Hospital
Zhizheng Ge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 75 years and referred to capsule endoscopy because of suspected small-bowel disease are prospectively eligible for entry into the study.
Exclusion criteria
* Age \< 18 or \> 75 years * Known or suspected GI stricture or fistula * A history of GI tract resection * Swallowing disorders * Intensive therapy with fasting and parenteral nutrition;with a disease that may reduce movement of the GI tract, such as diabetes mellitus * Medications that could affect gastrointestinal movement within one week * Implanted with a medical electronic device * Active inflammatory bowel disease, toxic megacolon, toxic colitis * Severe pulmonary, cardiac, renal, or hepatic disease * Uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg); * Disturbance of electrolytes * Pregnancy or lactation * Patients inability to provide written voluntary informed consent * Participation in another clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the quality of visualization of the small bowel | one week after CE procedure | The image quality was evaluated only in cases in which the capsule reached the cecum within the examination period. All CE images will be assessed at low speed (10 frames/s) under the AutoView mode of the RAPID workstation (Given Imaging). The intestinal mucosa is defined as clean if, less than 25% of the mucosal surface was covered by dark liquid, bubbles or debris. Using a timer, the investigators record the exact time period during which the small intestinal mucosa was clean. The definition of excellent is at least 90% of the overall small bowel mucosa is clean (the sum of clean time /total small bowel transit time\>90%). And the definition of good is at least 80% of the overall small bowel mucosa is clean. We considered that excellent or good preparation is adequate to make an accurate diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient acceptability | day of CE procedure | A visual analogical scale (VAS) is used to evaluate the degree of patients' discomfort. The numerical scale between 0 and 10, with 0 being no burden at all and 10 indicating an intolerable procedure. The questionnaire provide information about whether they experienced nausea, bloating, or any discomfort during the bowel preparation, difficulty to complete the preparation, their willingness to repeat the same preparation in the future (yes or no)and did it affect their daily activity and nocturnal rest. |
| diagnostic rate | one year | — |
Countries
China
Outcome results
None listed