A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.
This is a prospective randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patients with high-risk bleeding gastroduodenal ulcers. The primary outcome is comparing the hemostatic rates of the devices. Secondary outcomes are rebleeding rate at 7 and 30 days after index intervention, survival rate after intervention, procedure time for achieving hemostasis, number of units of infused blood, duration of hospitalization, and complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.
The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.
Faculty of internal medicine siriraj hospital, Mahidol university
Bangkok Noi, Bangkok, Thailand
RECRUITINGComparing hemostatic rate between hemostatic forceps and bipolar electrocautery probes
When the bleeding stopped for at least 2 minutes, it is defined as successful hemostasis.
Time frame: During esophagogastroduodenoscopy
Rebleeding rate at 7 days and 30 days after index intervention
After primary hemostasis, patients will be follow up at 7 and 30 days for evidence of rebleeding.
Time frame: 30 days
Survival rate after intervention
Patients who live longer than 30 days after hemostasis will be counted for survival rate.
Time frame: 30 days
Procedure time for achieving hemostasis
Procedure time will be counted from the time of device insertion to the time of achieving hemostasis.
Time frame: During esophagogastroduodenoscopy
Number of units of infused blood
Number of red cell units which are transfused to the patients.
Time frame: 30 days
Duration of hospitalization
The length of hospital stay.
Time frame: 30 days
Complications of hemostatic interventions
Complications related to intervention include perforation, infection, and organ failure
Time frame: 30 days
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