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

NCT01269814 | Unknown DMC

• 1 other identifier: Rockall-GIH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Hemorrhage

Keywords

Gastrointestinal bleeding; Emergency endoscopy; Rockall Risk Scoring System

Outcome Measures

Primary Outcomes (1)

• The necessity of emergency endoscopy.

  1 month

Secondary Outcomes (3)

• Morbidity

  1 month

• Mortality

  1 month

• Length of hospital stay

  1 month

Study Arms (1)

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

Interventions

Gastroscopy PROCEDURE

Gastroscopy

Go-home group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients older than 18 years with upper gastrointestinal hemorrhage.

You may qualify if:

• Clinical diagnosis of upper gastrointestinal system bleeding
• Rockall score of 1 or less
• Volunteers
• Agreement with the terms of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Halil Alis, MD

  Dr. Sadi Konuk Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Osman Kones, MD

CONTACT

090-542-36968282; osman.kones@beah.gov.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: January 4, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 17, 2012

Record last verified: 2012-10

Locations

TU (1)