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

CHRONIC LIVER DISEASE Clinical Trial

— vocal penn 01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06227988
• Other study ID #: Vocal penn score 01
• Status: Recruiting
• Start date: June 20, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: January 2024
• Source: Asian Institute of Gastroenterology, India
• Contact: PRACHITI Gokhe
• Phone: 8830117645
• Email: PRACHITI1331[@]GMAIL.COM
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• CHRONIC LIVER DISEASE
• Liver Diseases

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
India	Dr Prachiti Gokhe	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	2 years