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RecruitingNCT06227988vocal penn 01Updated Jan 29, 2024

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

An observational study in CHRONIC LIVER DISEASE, sponsored by Asian Institute of Gastroenterology, India. Recruiting at 1 site in India. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.

Sponsored by Asian Institute of Gastroenterology, India · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
53
Ages
18 Years to 65 Years
Sex
All
01

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

Read the 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.

02

Conditions studied

  • CHRONIC LIVER DISEASE

Browse trials for

Keywords

  • Fluid buildup in the belly (ascites)
  • Gallstones.
  • Muscle loss.
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 53 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Asian Institute of Gastroenterology, India is the lead sponsor of 132 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

  1. STUDY POPULATION Data of 53 patients with liver disease who undergoing surgery of interest will be included
  2. DESIGN AND DURATION OF THE STUDY

Prospective observational study Duration 2 years

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

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

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
53 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients 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.

    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

    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.

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

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.

06

What researchers measure

Primary outcomes

  1. To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score

    . For comparison between prediction scores receiver operative curves will be used.

    Time frame: 2 years

Secondary outcomes

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

    For subgroup analysis comparison between groups independent sample T test will be used. used.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06227988
Lead sponsor
Asian Institute of Gastroenterology, India
Responsible party
Sponsor
First posted
Jan 29, 2024
Start date
Jun 20, 2023
Primary completion
Jul 30, 2025 (estimated)
Completion
Jul 30, 2025 (estimated)
Last update
Jan 29, 2024

Study contacts

PRACHITI Gokhe
Contact
PRACHITI1331@GMAIL.COM
8830117645
MAHESH SHETTY
Contact
DRMAHESHGSHETTY@HOTMAIL.COM
9848225528
PRACHITI Gokhe
principal investigator · AIG HOSPITALS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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