Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06227988
Acronym
vocal penn 01
Enrollment
53
Registered
2024-01-29
Start date
2023-06-20
Completion date
2025-07-30
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHRONIC LIVER DISEASE

Keywords

Fluid buildup in the belly (ascites), Gallstones., Muscle loss.

Brief 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

Detailed 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.

Interventions

PROCEDUREpatients with liver disease who undergoing surgery

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.

PROCEDUREpatients with liver disease who do not undergoing surgery

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.

Sponsors

Asian Institute of Gastroenterology, India
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score2 years. For comparison between prediction scores receiver operative curves will be used.

Secondary

MeasureTime frameDescription
To assess potential differences in prediction accuracy between VOCAL-Penn and MELD for 30 and 90-day mortality2 yearsFor subgroup analysis comparison between groups independent sample T test will be used. used.

Countries

India

Contacts

Primary ContactPRACHITI Gokhe
PRACHITI1331@GMAIL.COM8830117645
Backup ContactMAHESH SHETTY
DRMAHESHGSHETTY@HOTMAIL.COM9848225528

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026