ASSESSMENT OF SURGICAL RISK IN PATIENTS WITH CHRONIC LIVER DISEASE USING VOCAL PENN SCORE

Last updated: January 19, 2024
Sponsor: Asian Institute of Gastroenterology, India
Overall Status: Active - Recruiting

Phase

N/A

Condition

Primary Biliary Cholangitis

Hepatitis C; Chronic

Hepatic Fibrosis

Treatment

patients with liver disease who undergoing surgery

patients with liver disease who do not undergoing surgery

Clinical Study ID

NCT06227988
Vocal penn score 01
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

4a. Primary To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score

4b. Secondary To assess potential differences in prediction accuracy between VOCAL-Penn and MELD for 30 and 90-day mortality

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with established cirrhosis Patients who had not received livertransplantation and who underwent surgery of interest were included These surgerycategories will be the same as those used in the original VOCAL-Penn derivation studyand will include the open abdominal, laparoscopic abdominal, and abdominal wall.

Exclusion

Exclusion Criteria:

  • Patients with insufficient pre-operative data to compute the VOCAL-Penn score, Mayorisk score, or MELD-Na score will be excluded. Patients undergoing liver surgeries Patients who received multiple surgeries Those whodidn't give consent

Study Design

Total Participants: 53
Treatment Group(s): 2
Primary Treatment: patients with liver disease who undergoing surgery
Phase:
Study Start date:
June 20, 2023
Estimated Completion Date:
July 30, 2025

Study Description

For each patient and surgery,we will be collecting detailed pre-operative data regarding demographics (age, sex, body mass index, surgery category, comorbidities (diabetes mellitus, hypertension), and pertinent laboratory values (sodium, creatinine, total bilirubin, the international normalized ratio [INR], albumin, platelet count.) The etiology of liver disease will be classified.

To ensure that laboratory data accurately reflected the pre-operative state, only those from within 30 days prior to surgery will be considered For each patient VOCAL PENN score, MELD score, and Mayo score will be calculated using an online calculator.

Connect with a study center

  • Dr Prachiti Gokhe

    Hyderabad, Telangana 500082
    India

    Active - Recruiting

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