跳至主要内容
临床试验/NCT06227988
NCT06227988招募中不适用

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

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
53
试验地点
1
主要终点
To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

结局指标

主要结局

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

时间窗: 2 years

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

次要结局

  • To assess potential differences in prediction accuracy between VOCAL-Penn and MELD for 30 and 90-day mortality(2 years)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Sponsor

研究点 (1)

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