A Randomized Trial of Hemostatic Forceps Versus Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• The patient with upper gastrointestinal hemorrhage age ≥ 18 years old
• The patient with gastroduodenal ulcer with indication for hemostatic intervention including 2.1 Forrest classification 1a (Active spurting) 2.2 Forrest classification 1b (Active oozing) 2.3 Forrest classification 2a (Non-bleeding visible vessel; NBVV) 2.4 Forrest classification 2b (Adherent clot) with lesion underneath clot which need hemostatic intervention including active spurting, active oozing or non-bleeding visible vessel
Locations
Other Locations
Thailand
Faculty of internal medicine siriraj hospital, Mahidol university
RECRUITING
Bangkok Noi
Contact Information
Primary
Uayporn Kaosombattwattana, MD
Koigi214@gmail.com
+66619245953
Time Frame
Start Date: 2024-03-26
Estimated Completion Date: 2026-04-26
Participants
Target number of participants: 150
Treatments
Experimental: Hemostatic forceps
Hemostatic forceps will be used for control bleeding with electrocautery unit setting: 80 W, effect 4, soft coagulation mode for 1-2 seconds.
Active_comparator: Bipolar electrocautery probes
Bipolar electrocautery probes will be used for control bleeding with electrocautery unit setting: effect 2, soft coagulation bipolar mode for 8-10 seconds.
Related Therapeutic Areas
Sponsors
Leads: Mahidol University