Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT05140057
Brief Summary:
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:
NCT05140057
Study Brief:
Protocol Section:
NCT05140057