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ASSESSMENT OF SURGICAL RISK IN PATIENTS WITH CHRONIC LIVER DISEASE USING VOCAL PENN SCORE (vocal penn 01)

A

Asian Institute of Gastroenterology, India

Status

Enrolling

Conditions

CHRONIC LIVER DISEASE

Treatments

Procedure: patients with liver disease who do not undergoing surgery
Procedure: patients with liver disease who undergoing surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06227988
Vocal penn score 01

Details and patient eligibility

About

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

Full 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.

Enrollment

53 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Patients with insufficient pre-operative data to compute the VOCAL-Penn score, Mayo risk score, or MELD-Na score will be excluded.

Patients undergoing liver surgeries Patients who received multiple surgeries Those who didn't give consent

Trial design

53 participants in 2 patient groups

patients with liver disease who undergoing surgery
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.
Treatment:
Procedure: patients with liver disease who undergoing surgery
Procedure: patients with liver disease who do not undergoing surgery
patients with liver disease who do not undergoing surgery
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.
Treatment:
Procedure: patients with liver disease who undergoing surgery
Procedure: patients with liver disease who do not undergoing surgery

Trial contacts and locations

1

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Central trial contact

MAHESH SHETTY; PRACHITI Gokhe

Data sourced from clinicaltrials.gov

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