NCT05503836

Brief Summary

  • Determine the ability of Child Pugh, MELD, and ALBI scores to predict mortality and morbidity in cirrhotic patients undergoing abdominal surgeries.
  • Evaluate the prognostic efficacy of ALBI score versus CTP and MELD scores to predict mortality and morbidity in cirrhotic patients undergoing abdominal surgeries

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

August 6, 2022

Last Update Submit

August 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • frequency of deaths and number of cases with hepatic decompensation and compliication

    As we will follow up the patient for 30 days after surgery

    Between August 2022 and August 2024

Interventions

abdominal surgeries

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All confirmed cases of cirrhosis aged ≥ 18 years of either sex, admitted to the Assiut university hospitals for abdominal surgeries (elective or emergency) .

You may qualify if:

  • o All confirmed cases of cirrhosis aged ≥ 18 years of either sex, admitted to the Assiut university hospitals for abdominal surgeries (elective or emergency) were enrolled in the study.
  • Cirrhosis is confirmed by the following diagnostic criteria :
  • Clinical history and examination with special stress on symptoms and signs of chronic liver disease with or without evidence of hepatic decompensation e.g. the presence of ascites and with or without evidence of complications e.g. jaundice, bleeding varices, ascites, and lower limb edema.
  • Laboratory findings in the form of raised bilirubin, impaired coagulation profile, and/or low serum albumin.
  • Abdominal ultrasonography revealing liver cirrhosis (coarse echo pattern, attenuated hepatic veins, irregular outlines, hypertrophy of caudate lobe and/or shrunken liver, and presence of splenomegaly, ascites )

You may not qualify if:

  • o Cirrhotic patients undergoing extra abdominal surgeries.
  • Patients admitted for liver transplantation.
  • Patients less than 18 years of age.
  • Patients refused to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Naqvi IH, Talib A, Mahmood K, Abidi R, Rizvi SNZ. The ability of the new ALBI scoring in predicting mortality, complications and prognostic comparison among cirrhotics. Prz Gastroenterol. 2019;14(4):250-257. doi: 10.5114/pg.2019.83872. Epub 2019 Mar 25.

    PMID: 31988671BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • .Mohamed Omar, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Tasneem Khaled, Ass. lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 6, 2022

First Posted

August 17, 2022

Study Start

August 15, 2022

Primary Completion

August 30, 2024

Study Completion

September 1, 2024

Last Updated

August 17, 2022

Record last verified: 2022-08