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临床试验/NCT05202457
NCT05202457已完成不适用

Review of Outcomes in Patients With Cirrhosis Undergoing General Surgery

Danny Lascano1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2017年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Number of patients that die at 30, 90 and 365 days after index surgery

研究概览

简要总结

Surgery on cirrhotic patients represents a clinical challenge but intervening before these patients develop complications can prolong the likelihood of these patients making it to transplant for those transplant-eligible candidates. There is no literature on survival to transplant afforded by surgery nor 90 day and 1-year outcomes after any surgical procedures on this population. The investigator's aim is to study the principal investigator's single surgical center experience at a tertiary hospital with the largest referral center in the area for liver transplant candidates. The investigators hypothesize, that although the risk is high for patients undergoing surgery it is much lower than historically reported, may make more patients eligible for transplant and prevent complications that may lead to death for the transplant eligible, and may reveal associations that can lead to good outcomes in this high-risk population.

详细描述

Introduction

The incidence of cirrhosis is increasing as alcoholic liver disease overtakes hepatitis as the cause of cirrhosis although it will likely stabilize as Hepatitis C treatment makes its way through the population. However, liver disease continues to have a large impact on morbidity and mortality with a prevalence of approximately 4.5 million people diagnosed with liver disease with an incidence of 1.8% per year and 12.8 deaths per 100,000 people. The cost of treating cirrhosis ranges from $14 million to $2 billion dollars depending on the etiology of the disease. The large cost is driven by multiple hospitalizations, surgical procedures, rehabilitation/nursing home, and other factors.

For surgeons, cirrhotic patients represent an especially high-risk patient population. In the past, many surgeons were hesitant to offer definitive surgeries for symptomatic cholelithiasis, hernias, or cancer surgeries. Historically these patients had a high risk of mortality with competing causes of mortality driven by liver cirrhosis as well as other issues. Hence, it was thought that these patients should only be operated on in emergent cases unless it precluded them from being transplant eligible. For example, Garrison, et al. noted in 1984 that patients who underwent exploratory laparotomy with either a Child B and C had a 31% and 76% mortality, respectively. Furthermore, this was not unique to that group as another group in 1997 showed surgeries like hernia procedures, cholecystectomy, and other procedures had mortality rates of up to 82% for Child C cirrhotics. As general post-surgical care and critical care have improved, contemporary studies show that mortality although decreased still is significant. A prospective study looking at cirrhotic patients who underwent an umbilical hernia for 30 patients had a mortality of 6%. Moreover, a retrospective analysis of a prospectively maintained database from the American College of Surgeons National Surgical Quality Improvement Program revealed that in a series of 390 pts undergoing umbilical hernia repair there was a 5.1% mortality and 13.1% morbidity in comparison to 0.1 and 3.9% on non-cirrhotic patients, respectively.

There are few papers that look at the drivers of morbidity, mortality, and complications among this population and none looking at more than 30 days post-operative re-admissions, morbidity, or mortality. Furthermore, there is no literature on how elective or emergent surgery may facilitate a longer survival so that patients may still be alive and eligible to receive their liver, the ultimate treatment for liver cirrhosis. Hence, the investigator's tertiary center experience was evaluated focusing on pre-operative, intraoperative, and postoperative factors that may explain the drivers of morbidity and mortality in cirrhotics undergoing elective and emergent surgery. The investigators will also study at how many patients after their index procedure survived to receive their liver transplant. Hence, the investigator's surgical, single-center experience at a tertiary hospital with the largest referral center in the area for liver transplant candidates for any cirrhotics requiring surgery either emergent (<24 hours since admission), urgent (same admission but > 24 hrs), or elective (patient coming from outpatient setting for planned surgery). The investigators hypothesize, that although the risk is high for patients undergoing surgery, it currently is much lower than historically reported, which may make more patients eligible for transplant and prevent complications that may lead to death for the transplant eligible patients, and may reveal associations that can lead to good outcomes in this high-risk population.

Materials and Methods

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • All non-transplant surgical procedures by the principal investigator over a 5-year period (2013-2018)
  • Patients with a known, symptomatic and documented pre-operative history of cirrhosis

排除标准

  • Asymptomatic or incidentally discovered cirrhosis

结局指标

主要结局

Number of patients that die at 30, 90 and 365 days after index surgery

时间窗: 1 year

Death within 30, 90 and 365 days after surgery

次要结局

  • Number of patients that have a complication at 30, 90 and 365 days after index surgery(1 year)
  • Number of patients that receive a liver transplant after their index surgery(1 year)

研究者

发起方
Danny Lascano
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Danny Lascano

Research Resident

Westchester Medical Center

研究点 (1)

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