A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer
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|ClinicalTrials.gov Identifier: NCT00164931|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Peptic Ulcer Hemorrhage||Drug: Intravenous omeprazole infusion Procedure: Scheduled second endoscopy||Phase 3|
We have previously performed a prospective randomized controlled trial on the effect of scheduled second endoscopy upon peptic ulcer rebleeding. We found that the rate of recurrent bleeding was significantly reduced from 13.8% to 5% with a scheduled second endoscopy and appropriate therapy performed within 24 hours after initial hemostasis.
When we look at the studies in the literature employing proton pump inhibitors (PPI) infusion after primary endoscopic therapy, we found that there was also a significant reduction in the rate of rebleeding, the number of operation performed and the transfusion requirement.
Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis. A recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding.
We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endoscopy|
|Study Start Date :||October 2003|
- Recurrent bleeding within 30 days after initial endoscopy defined as -
- Clinical criteria (anyone of the below)
- 1. Haemetmesis or fresh blood from Ryles tube
- 2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl
- 3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy
- 4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs
- AND Endoscopic criteria of Forrest I a, b or II a, b
- 1. The rate of surgery
- 2. Mortality
- 3. Length of Hospital stay
- 4. Transfusion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164931
|Department of Surgery, United Christian Hospital|
|Hong Kong, China|
|Principal Investigator:||Philip WY Chiu, MBChB, FRCSEd||Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong|
|Principal Investigator:||Henry KM Joeng, MBBS||Department of Surgery, United Christian Hospital, Hong Kong|