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Controlled-randomized trial evaluating single-use versus reusable gastroscopes in patients with upper gastrointestinal bleeding.
Acute upper gastrointestinal bleeding is a common medical emergency. According to guidelines, endoscopic evaluation should be performed within 24 hours. With an overall high incidence and an overall high number of diagnostic and therapeutic endoscopic procedures, the introduction of new endoscopic concepts may have a profound impact on outcomes as well as cost-effectiveness in upper gastrointestinal bleeding. For this purpose, the use of single-use gastroscopes represents an interesting possibility. Hygiene issues in the emergency situation are also relevant. The previous feasibility study One-Scope I demonstrated that the diagnosis as well as the therapy of upper gastrointestinal bleeding is possible with single-use gastroscopes. In this follow-up study, the investigators compare the use of single-use versus reusable gastroscopes in participants with suspected upper gastrointestinal bleeding in a randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-use gastroscope | Experimental | A disposable endoscope designed for a one-time use during a Gastroscopy, eliminating the need for reprocessing or sterilization. After a single procedure, the entire gastroscope is discarded, reducing the risk of cross-contamination and ensuring a fresh, sterile instrument for each patient intervention |
|
| reusable gastroscope | Active Comparator | A durable endoscope designed for multiple uses after thorough reprocessing and sterilization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic hemostasis using a Esophagogastroduodenoscopy | Device | performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites |
|
| Measure | Description | Time Frame |
|---|---|---|
| intraprocedural technical success | defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site | Up to 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| intraprocedural clinical success | defined as successful endoscopic hemostasis during the examination if required | Up to 45 Minutes |
| re-bleeding rate | need for further endoscopic, interventional-angiographic, or surgical intervention within 30 days due to upper GI-bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Römmele, MD | Contact | +498214002351 | christoph.roemmele@uk-augsburg.de | |
| Alanna Ebigbo, MD | Contact | alanna.ebigbo@uk-augsburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Christoph Römmele, MD | Unervsity Hospital Augsburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Augsburg | Recruiting | Augsburg | Bavaria | 86156 | Germany |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| Up to 30 days |
| blood transfusions | Need for blood transfusion due to a hemorrhage-related decrease in hemoglobin levels ≤ 70 g/L | Up to 30 days |
| Length of Stay | Duration of inpatient stay, measured from the day of admission to the day of discharge | Up to 30 days |
| Length of intervention | measured from initiation to achievement of hemostasis | Up to 60 minutes |
| cross over to reusable gastroscope | Switch to a reusable gastroscope in case of non-achieved technical or clinical success, such as unsuccessful hemostasis, insufficient assessment of the bleeding source, or inability to reach the descending duodenum | Up to 60 Minutes |
| Adverse events | Occurrence of adverse events, such as perforation, bleeding exacerbation, aspiration, and infection. | Up to 30 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |