Small bowel capsule endoscopy (SBCE) has become an important tool in clinical practice since its introduction in 2000. This non-invasive method allows the visualization of small bowel mucosa, being essential in the management of many conditions, such as suspected small bowel bleeding, inflammatory bowel diseases and intestinal polyposis syndromes. Despite recommendations concerning SBCE in different pathologies, there are still some technical concerns to be addressed. The optimal preparation for SBCE has been one of these controversial issues. Currently, the European Society of Gastrointestinal Endoscopy (ESGE) recommends that patients ingest a purgative agent (2L of polyethylene glycol, PEG) and antifoaming agents for SBCE, because it was associated with a better visualization. However, it remains unclear which is the optimal timing for purgative use. Furthermore, the use of a booster agent after capsule ingestion is already performed in colon capsule endoscopy, but less is known about its application in SBCE. Also, it remains to be clarified whether a better visualization results in higher diagnostic yield and impacts patients' outcomes. Therefore, the global aim of this prospective, randomized, multi-centric study is to determine the optimal timing and preparation for small-bowel capsule endoscopy (regardless of the equipment used), comparing four groups of different preparation protocols: * Protocol 1) 1L of Moviprep® solution the night before the procedure * Protocol 2) 1L of Moviprep® solution up to 2h before the procedure * Protocol 3) 0.5L of Moviprep® solution up to 2h before the procedure plus 0.5L of Moviprep® solution after the capsule had reached the duodenum (assessed with real-time viewer) * Protocol 4) 1L of Moviprep® solution after the capsule had reached the duodenum (assessed using real-time viewer)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
210
Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings
Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Portugal
RECRUITINGDiagnostic yield
Proportion of SBCE with positive findings. findings will be classified based on the Saurin classification; the investigators will consider a positive SBCE when lesions classified as P2 or active bleeding are detected (Saurin classification, Table 2), the remaining will be classified as negative
Time frame: During the procedure
Adequate cleansing rate
A cutoff value of quantitative index ≥ 8 points
Time frame: During the procedure
Proportion of SBCE with vascular lesions
Vascular lesions identified in each tertile
Time frame: During the procedure
Proportion of SBCE with active bleeding
Active bleeding in each tertile
Time frame: During the procedure
Diagnostic yield per tertile
Positive findings in each tertile
Time frame: During the procedure
Transit times
Time of entry in the stomach, duodenum and cecum
Time frame: During the procedure
Symptoms experienced during SBCE procedure
Nausea, vomit, bloating, abdominal pain
Time frame: During the procedure
Overall patients' satisfaction with the cleansing regimen
rated on a 5-point scale: 1 - very easy, 2 - easy, 3 - intermediate, 4 - difficult, 5 - very difficult
Time frame: During the procedure
Small bowel cleansing
Mean quantitative index of the distal third of small bowel
Time frame: During the procedure
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