The Impact of Rockall Risk Scoring System on Management of Upper Gastrointestinal System Bleeding
Recruitment status was Recruiting
The patients who admit to emergency department with upper gastrointestinal system bleeding will undergo a clinical evaluation with Rockall Risk Scoring System. The patients with Rockall score of 1 or less will be discharged with medical treatment, and will have an elective upper gastrointestinal endoscopy in the end of the 30th day. The impact of Rockall Risk Scoring System on assessing the necessity of emergency endoscopy, length of hospital stay, morbidity, and mortality in low-risk patients will be evaluated.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||The Impact of Rockall Risk Scoring System on Timing of Endoscopy, Length of Hospital Stay, Morbidity and Mortality in Patients With Upper Gastrointestinal System Bleeding|
- The necessity of emergency endoscopy. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Morbidity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
The patients with a Rockall score of 0 or 1 will be prescribed medical therapy, and will be scheduled for elective gastroscopy.
The patients who admit to emergency department with symptoms of upper gastrointestinal system bleeding will undergo a clinical evaluation. First, diagnosis of upper gastrointestinal system bleeding will be established by combined physical examination and nasogastric tube application. After a certain diagnosis, all of the patients will be scored according to Rockall Risk Scoring System. The patients with a 1 or less Rockall score will have conservative treatment including mucosal protective agent (sucralfat), proton pump inhibitors (omeprazole, lansoprazole, pantoprazole), and hemodynamic monitorization. Should Rockall score and hemodynamic parameters remain unchanged or get improved in the end of 6 hours after admission, oral feeding will be started and the patient will be discharged with anti-ulcer medication (mucosal protective agent and proton pump inhibitor, PO). These patients will be scheduled for upper gastrointestinal endoscopy at 30th day. The patients who have: an initial Rockall score of 2 or greater, an increase in Rockall score or deterioration in hemodynamic parameters during observation, will have emergency endoscopy and will be excluded from the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269814
|Contact: Osman Kones, MDfirstname.lastname@example.org|
|Dr. Sadi Konuk Training and Research Hospital||Recruiting|
|Istanbul, Turkey, 34147|
|Contact: Halil Alis, MD 090-505-2327425 email@example.com|
|Principal Investigator: Osman Kones, MD|
|Study Director:||Halil Alis, MD||Dr. Sadi Konuk Training and Research Hospital|