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

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01269814
Collaborator
(none)
100
1
27
3.7

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
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
Study Start Date :
Dec 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2012
Anticipated Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. The necessity of emergency endoscopy. [1 month]

Secondary Outcome Measures

  1. Morbidity [1 month]

  2. Mortality [1 month]

  3. Length of hospital stay [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Dr. Sadi Konuk Training and Research Hospital Istanbul Turkey 34147

Sponsors and Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Study Director: Halil Alis, MD, Dr. Sadi Konuk Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Murat Gonenc, Medical Doctor, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT01269814
Other Study ID Numbers:
  • Rockall-GIH
First Posted:
Jan 4, 2011
Last Update Posted:
Oct 17, 2012
Last Verified:
Oct 1, 2012
Keywords provided by Murat Gonenc, Medical Doctor, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2012