ASSESSMENT OF SURGICAL RISK IN PATIENTS WITH CHRONIC LIVER DISEASE USING VOCAL PENN SCORE
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score
Time Frame: 2 years
. For comparison between prediction scores receiver operative curves will be used.
Secondary Outcomes
- To assess potential differences in prediction accuracy between VOCAL-Penn and MELD for 30 and 90-day mortality(2 years)