Bowel Preparation
Conditions
Brief summary
To compare the small bowel cleanliness for wireless capsule endoscopy using two different Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion versus in a split-dose fashion).
Detailed description
The image quality obtained from the wireless capsule endoscopy improves its diagnostic yield. The amount of visualized mucosa is in direct correlation with the diagnostic yield. Nonetheless, frequently, the quality of the image obtained is hampered by the presence of bubbles, debris, bile and enteric fluid. Therefore many efforts have been putted in order to eliminate this factor such as the use of prokinetics, simethicone and bowel purgatives. The latter (namely the polyethylene glycol - PEG - solution) has accumulated evidence and is, therefore, recommended by the last European guidelines. Usually, the cleansing starts and finish in the day before the capsule endoscopy ingestion. We hypothesized that, similarly to what had become evidence to large bowel cleansing, a shorter gap between the polyethylene glycol intake and the exam could provide a better capsule endoscopy image quality and therefore gauging our diagnostic yield.
Interventions
DEVICECapsule endoscopy
Endoscopic device
DRUGPolyethylene Glycol
Bowel purgative
Sponsors
Centro Hospitalar Lisboa Ocidental
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All adult patients referred to our institution for CE during the study period
Exclusion criteria
* inpatients, bedridden, patients with clinical evidence of active bleeding, past history of abdominal surgery, abdominal or pelvic radiation therapy, occlusion, bowel perforation (suspected or confirmed), use of oral iron replacement therapy, severe cardiopulmonary, renal or hepatic disease, pregnancy, hypersensitivity to any components of the preparation, patients that didn't complete the preparation protocol, patients with incomplete enteroscopies (a complete enteroscopy is defined by the visualization of the mucosa from the duodenal bulb to the cecum), patients enrolled in other clinical studies and patients who didn't signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Small-bowel cleanliness | at the end of capsule endoscopy exploration | The cleansing quality of the small-bowel will be evaluated according to the system validated by Brotz et al., using the quantitative index (QI), because this score is less susceptible to the subjective element. The used cut-off value accepted for an adequate small-bowel cleansing was ≥ 8 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of all the observed lesions | at the end of capsule endoscopy exploration | Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential. |
| The clinical tolerance questionnaire | at the end of capsule endoscopy exploration | Evaluate the clinical tolerance and the acceptability of the bowel preparation with the oral polyethylene glycol solution. |
| The transit time | at the end of capsule endoscopy exploration | Compare gastric transit time and the small bowel transit time. |
Countries
Portugal
Contacts
Primary ContactPedro Magalhães-Costa, MD
Outcome results
None listed