Prospective-randomized trial. Patients with recurrent bleeding from gastroduodenal ulcers are randomized into either endoscopic treatment with the OTSC \[Over The Scope Clip\] or endoscopic standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Hemostasis with Standard Therapy (standard clip or thermal therapy + injection of adrenaline solution) or by application of the Over The Scope Clip and injection of adrenaline solution
Klinikum Ludwigsburg
Ludwigsburg, Germany
RECRUITINGPersistent bleeding or Rebleeding with 7 days
Time frame: 7 days
blood units transfused
Time frame: 30 days
duration of hospital stay
Time frame: 30 days
duration of intensive care unit stay
Time frame: 30 days
30 d Mortality
Time frame: 30 days
Amount of endoscopic reinterventions
Time frame: 7 d
Necessity of surgical or angiographic therapy
Time frame: 7 d
Complications during or after OTSC (Over The Scope Clip) placement
Time frame: 7 d
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