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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy | Gastrointestinal bleeding in the small bowel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Small bowel capsule endoscopy | Device | Patients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of small bowel bleeding detected during small bowel capsule endoscopy | Detection of bleeding during small bowel capsule endoscopy | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of vascular lesions as source of bleeding | Detection of vascular lesions angiodysplasia) as source of bleeding | Through study completion, an average of 1 year |
| Prevalence of inflammatory lesions as source of bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who present with gastrointestinal bleeding undetected in gastroscopy or colonoscopy will be included in this cohort study. In these patients bleeding in the small bowel is suspected and they are allocated to a diagnostic assessment with small bowel capsule endoscopy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Schultheiss, MD | Contact | +49761/270-34010 | michael.schultheiss@uniklinik-freiburg.de | |
| Dominik Bettinger, MD | Contact | +49761/270-36870 | dominik.bettinger@uniklinik-freiburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Michael Schultheiss, MD | University Medical Center Freiburg, Department of Medicine II, Freiburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Freiburg, Department of Medicine II | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29539652 | Background | Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/a-0576-0566. Epub 2018 Mar 14. |
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IPD are shared on reasonable request to the Principal Investigator.
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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Detection of inflammatory lesions as source of bleeding
| Through study completion, an average of 1 year |
| Prevalence of tumor lesions as source of bleeding | Detection of tumor lesions as source of bleeding | Through study completion, an average of 1 year |
| Complications of small bowel capsule endoscopy | Complications of small bowel capsule endoscopy | Through study completion, an average of 1 year |
| Technical success of small bowel capsule endoscopy | Technical success is defined as arrival of the capsule in the cecum | Through study completion, an average of 1 year |
| Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding | Time between diagnostic mall bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding | From time to the end of capsule endoscopy until beginning of small bowel enteroscopy |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |