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

NCT06227988 | Unknown

• 1 other identifier: Vocal penn score 01
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

CHRONIC LIVER DISEASE

Keywords

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

Outcome Measures

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.

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (2)

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

patients with liver disease who undergoing surgery PROCEDURE

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; patients with liver disease who undergoing surgery

patients with liver disease who do not undergoing surgery PROCEDURE

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; patients with liver disease who undergoing surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Dr Prachiti Gokhe

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Ascites; Gallstones; Muscular Atrophy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Signs and Symptoms

Study Officials

• PRACHITI Gokhe

  AIG HOSPITALS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PRACHITI Gokhe

CONTACT

8830117645; PRACHITI1331@GMAIL.COM

MAHESH SHETTY

CONTACT

9848225528; DRMAHESHGSHETTY@HOTMAIL.COM

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: June 20, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)