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Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage

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ClinicalTrials.gov Identifier: NCT02405286
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University

Brief Summary:
This study aimed to Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

Condition or disease Intervention/treatment
Gastrointestinal Bleeding Other: Upper gastrointestinal endoscopy

Detailed Description:

This present study aimed to evaluate:

Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

1- Technical Design: The technical design included research design, setting, subject and tools for data collection.

Research design:

A descriptive exploratory design was followed to achieve the aim of the study. Study setting: This study was conducted between Tropical department in AinShams university and Gastroenterology and Hepatology department in TheodorBilharz Research Institute.

Sample size: EPI - INFO program version 6 was used for sample size calculation guided by power of the test = 80% - confidence level =95% and accepted margin of error = 5% and risk ratio = 5.5 - total sample minimum accepted = 50 This study included 50 recipients and done Tropical department in Ain Shams university and Gastroenterology and Hepatology department in .

Theodore Bilharz Research Institute


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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Upeer gastrointestinal bleeding
  • Adult Egyptian patients.
  • Patients with acute upper G.I hemorrhage.
  • Informed consent.
Other: Upper gastrointestinal endoscopy
Upper gastrointestinal endoscopy, if stigmata of recent hemorrhage are seen, varices are either injected with ethanolamine or banded, depending on the clinical setting and availability .




Primary Outcome Measures :
  1. Clinical condition of the patients with accute upper gastrointstinal bleeding after 48 hours from endoscopy [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. number of participants with variceal bleeding and other causes of upper gastrointestinal bleeding regarding the clinical condition after 48 hours [ Time Frame: 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Egyptian patients with acute upper gastrointestinal bleeding
Criteria

Inclusion Criteria:

  • Adult Egyptian patients.
  • Patients with acute upper G.I hemorrhage.
  • Informed consent.

Exclusion Criteria:

  • Refuse to participate in this study.

Information from the National Library of Medicine

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): NCT02405286


Locations
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Egypt
Egypt Ain Shams center University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Iman Fawzy Montasser, Lecturer of tropical medicine , Ain Shams university, Ain Shams University
ClinicalTrials.gov Identifier: NCT02405286     History of Changes
Other Study ID Numbers: Rockall score
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases