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

NCT ID: NCT01269814

Last Updated: 2012-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastrointestinal Hemorrhage

Keywords

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Gastrointestinal bleeding Emergency endoscopy Rockall Risk Scoring System

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Gastroscopy

Intervention Type PROCEDURE

Gastroscopy

Interventions

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Gastroscopy

Gastroscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Murat Gonenc

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Halil Alis, MD

Role: STUDY_DIRECTOR

Dr. Sadi Konuk Training and Research Hospital

Locations

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Dr. Sadi Konuk Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Osman Kones, MD

Role: CONTACT

Phone: 090-542-36968282

Email: [email protected]

Facility Contacts

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Halil Alis, MD

Role: primary

Other Identifiers

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Rockall-GIH

Identifier Type: -

Identifier Source: org_study_id