University Medical Center Freiburg, Department of Medicine II
Freiburg im Breisgau, 79106, Germany
Location status: Recruiting
NCT Number: NCT05949268
Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Freiburg im Breisgau, 79106, Germany
Location status: Recruiting
Small bowel capsule endoscopy is considered the diagnostic gold standard in the diagnosis of diseases of the small bowel. Most indications for capsule endoscopy are overt small bowel bleedings - defined as gastrointestinal bleeding after negative gastroscopy and colonoscopy - or occult iron deficiency anemia. Timing of small bowel capsule endoscopy seems to be decisive for the diagnosis of small bowel bleeding: corresponding to the actual guidelines the detection of small bowel bleeding can be up to > 70% if the intervention is performed within 2 days. Treatment of small bowel bleedings can be performed with small bowel enteroscopy such as balloon or motorized spiral enteroscopy. Against this background this study investigates the rate of small bowel bleeding diagnosed in capsule endoscopy. The aim of the study is to report tumorous, vascular and inflammatory findings as well as complications and cecal accessibility. One focus of the study is the time between small bowel bleeding and small bowel capsule endoscopy and small bowel enteroscopy, respectively. Endoscopic therapies and further bleeding episodes are recorded. In order to determine the improved clinical outcome after the introduction of the shortened timing for recommendation published in 2022, a retrospective cohort should be included in addition to a prospective cohort.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy.
Time frame: Through study completion, an average of 1 year
Detection of bleeding during small bowel capsule endoscopy
Time frame: Through study completion, an average of 1 year
Detection of vascular lesions angiodysplasia) as source of bleeding
Time frame: Through study completion, an average of 1 year
Detection of inflammatory lesions as source of bleeding
Time frame: Through study completion, an average of 1 year
Detection of tumor lesions as source of bleeding
Time frame: Through study completion, an average of 1 year
Complications of small bowel capsule endoscopy
Time frame: Through study completion, an average of 1 year
Technical success is defined as arrival of the capsule in the cecum
Time frame: From time to the end of capsule endoscopy until beginning of small bowel enteroscopy
Time between diagnostic mall bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding
Interested in participating?
Request InfoUniversity Hospital Freiburg
Other
Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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