NCT06147115

Brief Summary

Objective This study aims to evaluate the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients. Design/Method A cross-sectional hospital-based study involved 150 adult Sudanese patients presenting with upper gastrointestinal bleeding (UGIB) of variceal origin. Patients with UGIB resulting from causes other than varices and those who declined participation were excluded. Data were collected through a structured questionnaire complemented by upper gastrointestinal tract endoscopy findings, and patients were followed up until discharge. Results The study encompassed 150 patients, predominantly male (117, 78%), aged between 18 and 60 years (n=119, 79%), residing mainly in central regions (134, 89%). The leading presenting complaints included hematemesis (70, 46.7%) and melena (22, 14.6%). Notably, peri-portal fibrosis (101, 67.3%) and cirrhosis (24, 16%) were the primary etiological factors, with a significant prevalence of alcohol consumption (87, 58%). Concerning the grade of esophageal varices, grades III and IV were most prevalent (67, 44.7% and 47, 31.3%, respectively), and fundal varices were identified in 13 patients (8.7%). The mean Rockall score was 3.83 ± 1.99, indicating moderate severity. Additionally, the Rockall score showed significant associations with the number of sessions, complications, bleeding recurrence, duration of hospital stay, and mortality (p \< 0.05). Conclusion Understanding the significance of the Rockall scoring system and its applicability to Sudanese patients with variceal bleeding has the potential to guide more effective strategies in the management of upper gastrointestinal tract bleeding, ultimately improving patient outcomes and reducing morbidity and mortality.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2012

Completed
11.2 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 20, 2023

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients

    The primary outcome measure in this study appears to be the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients presenting to the Mohammed Salih Idris Bleeding Center (MSIBC). The study aims to assess the effectiveness of the Rockall scoring system in predicting mortality, bleeding recurrence, and other clinical outcomes in Sudanese patients with variceal bleeding. The Rockall scoring system incorporates various factors, including age, evidence of shock, coexisting medical conditions, and the presence of visible signs of hemorrhage. The study investigates the association between Rockall scores and clinical outcomes such as mortality, bleeding recurrence, complications, duration of hospital stay, and interventions conducted. The validation of the Rockall scoring system in the context of variceal bleeding in Sudan is crucial for risk stratification and guiding the management of patients with variceal bleeding.

    June 2012 - Sep 2012

Interventions

The Rockall score is a validated mortality risk assessment for patients admitted with upper GI bleeding.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 150 patients were enrolled in the study between June and September 2012. The study comprised patients aged 18 years and older, presenting with upper gastrointestinal (GI) bleeding of variceal origin, who visited the outpatient and referral clinic at the center and reported primary complaints of upper GI bleeding (UGIB), including hematemesis and/or melena. Patients with upper GI bleeding resulting from causes other than varices, as well as those who declined to participate in the study, were excluded

You may qualify if:

  • aged 18 years and older
  • primary complaints of upper GI bleeding

You may not qualify if:

  • Patients with upper GI bleeding resulting from causes other than varices
  • who declined to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 27, 2023

Study Start

June 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 10, 2012

Last Updated

November 27, 2023

Record last verified: 2023-11