The Impact of Rockall Risk Scoring System on Management of Upper Gastrointestinal System Bleeding
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Hemorrhage |
Procedure: Gastroscopy |
Phase 4 |
| Study Type: | Observational |
| 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 ]
| Estimated Enrollment: | 100 |
| 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) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Go-home group
The patients with a Rockall score of 0 or 1 will be prescribed medical therapy, and will be scheduled for elective gastroscopy.
|
Procedure: Gastroscopy
Gastroscopy
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All patients older than 18 years with upper gastrointestinal hemorrhage.
Inclusion Criteria:
- Clinical diagnosis of upper gastrointestinal system bleeding
- Rockall score of 1 or less
- Volunteers
- Agreement with the terms of informed consent
Exclusion Criteria:
- Uncertain clinical diagnosis of upper gastrointestinal system bleeding
- Rockall score of 2 or greater
- Deterioration in hemodynamic parameters during follow-up
- Unwilling patients to join the study
- Disagreement with the terms of informed consent
Contacts and Locations| Contact: Osman Kones, MD | 090-542-36968282 | osman.kones@beah.gov.tr |
| Turkey | |
| Dr. Sadi Konuk Training and Research Hospital | Recruiting |
| Istanbul, Turkey, 34147 | |
| Contact: Halil Alis, MD 090-505-2327425 halilalis@yahoo.com | |
| Principal Investigator: Osman Kones, MD | |
| Study Director: | Halil Alis, MD | Dr. Sadi Konuk Training and Research Hospital |
More Information
No publications provided
| Responsible Party: | Murat Gonenc, Medical Doctor, Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
| ClinicalTrials.gov Identifier: | NCT01269814 History of Changes |
| Other Study ID Numbers: | Rockall-GIH |
| Study First Received: | December 30, 2010 |
| Last Updated: | October 16, 2012 |
| Health Authority: | United States: Food and Drug Administration Turkey: Ethics Committee |
Keywords provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
|
Gastrointestinal bleeding Emergency endoscopy Rockall Risk Scoring System |
Additional relevant MeSH terms:
|
Gastrointestinal Hemorrhage Hemorrhage Gastrointestinal Diseases Digestive System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013