The Impact of Rockall Risk Scoring System on Management of Upper Gastrointestinal System Bleeding

This study is currently recruiting participants.
Verified October 2012 by Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor:
Information provided by (Responsible Party):
Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT01269814
First received: December 30, 2010
Last updated: October 16, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:

Primary Outcome Measures:
  • The necessity of emergency endoscopy. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

All patients older than 18 years with upper gastrointestinal hemorrhage.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269814

Contacts
Contact: Osman Kones, MD 090-542-36968282 osman.kones@beah.gov.tr

Locations
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         
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Investigators
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 April 14, 2014