Obscure Gastrointestinal Bleeding
Conditions
Keywords
Small bowel capsule endoscopy, Obscure gastrointestinal bleeding, Bowel preparation
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)
Interventions
COMBINATION_PRODUCTMoviprep
Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings
Sponsors
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be 18 years old or older * Present OGIB (either occult or overt) * Agree with study's procedures and have signed the informed consent for the study and SBCE, prior to SBCE procedure
Exclusion criteria
* Patients performing capsule endoscopy in urgent setting for overt obscure GI bleeding * Inpatients or bedridden * History of surgery of the esophagus, stomach, small bowel, or colon * History of abdominal or pelvic radiation therapy * Suspected or confirmed stenosis or occlusion * Suspected or confirmed bowel perforation * Severe comorbidities, as defined by grade 3 severe decompensation in the Adult Comorbidity Evaluation-27 index (ACE-27) * Pregnant women * Patients using narcotics or prokinetics in the week before the SBCE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | During the procedure | 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 |
| Adequate cleansing rate | During the procedure | A cutoff value of quantitative index ≥ 8 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield per tertile | During the procedure | Positive findings in each tertile |
| Transit times | During the procedure | Time of entry in the stomach, duodenum and cecum |
| Proportion of SBCE with vascular lesions | During the procedure | Vascular lesions identified in each tertile |
| Overall patients' satisfaction with the cleansing regimen | During the procedure | rated on a 5-point scale: 1 - very easy, 2 - easy, 3 - intermediate, 4 - difficult, 5 - very difficult |
| Small bowel cleansing | During the procedure | Mean quantitative index of the distal third of small bowel |
| Symptoms experienced during SBCE procedure | During the procedure | Nausea, vomit, bloating, abdominal pain |
| Proportion of SBCE with active bleeding | During the procedure | Active bleeding in each tertile |
Countries
Portugal
Outcome results
None listed