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临床试验/NCT04985981
NCT04985981暂停不适用

The Prediction of Anastomotic Insufficiency Risk After Colorectal Surgery (PANIC) Study: Development and External Validation of an International, Multicenter Machine Learning Algorithm for Prediction of Anastomotic Insufficiency After Colonic or Colorectal Anastomosis

Michel Adamina, MD2 个研究点 分布在 1 个国家目标入组 11,000 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
11,000
试验地点
2
主要终点
Occurrence of Anastomotic leak

研究概览

简要总结

The Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study aims to establish a machine-learning-based application that allows for accurate preoperative prediction of patients at risk for anastomotic insufficiency after colon and colorectal surgery.

详细描述

Anastomotic insufficiency leads to clinical strains for patients, and significantly increases morbidity and mortality. On average, hospital stay is extended by 12 days while healthcare-related expenses are increased by 30,000 USD when patients suffer from an anastomotic leak. In experienced centers, the approximated incidence of anastomotic insufficiency is 3,3% for colon and 8.6% for colorectal procedures. Multiple subgroups of patients with increased risk for anastomotic leaks have been described in previous publications. Meticulous preoperative recognition of patients with increased risk for anastomotic insufficiency is clinically beneficial, as it would permit improved ressource preparation, enhanced patient education and superior surgical decision-making. However, it is often difficult for clinicians to balance the plethora of crucial risk factors for anastomotic leaks for a single patient. Machine learning methods have been exceptionally effective at incorporating various clinical variables into one unified risk prediction model. To the authors' best knowledge, there does not yet exist a credible prediction model or a conclusive prediction score for anastomotic insufficiency after colon and colorectal anastomosis. The aim of the Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study is to establish and externally validate an efficient machine-learning-based prediction tool based on multicenter data from a range of international centers.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Patients who underwent colon or colorectal anastomosis for neoplasia, diverticulitis, mesenterial ischemia, iatrogenic or traumatic perforation, or inflammatory bowel disease

排除标准

  • age < 18
  • recurrent colorectal cancer
  • peritoneal carcinomatosis or unresectable metastatic disease at time of bowel resection
  • informed consent not obtainable
  • follow-up < 6 weeks after surgery
  • no reversal of and ostomy

结局指标

主要结局

Occurrence of Anastomotic leak

时间窗: 5 years

Occurrence of anastomotic insufficiency/leak is defined as any clinical signs of leakage, confirmed by radiological examination, endoscopy, clinical examination of the anastomosis, or upon reoperation.

次要结局

  • Occurrence of Death(90 days)
  • Time to diagnosis of anastomotic leak(90 days)

研究者

发起方
Michel Adamina, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michel Adamina, MD

Chefarzt

Kantonsspital Winterthur KSW

研究点 (2)

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