跳至主要内容
临床试验/NCT05579912
NCT05579912已完成不适用

The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery: Is it Safe to Feed the Patient?

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 592 人开始时间: 2019年11月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
592
试验地点
1
主要终点
Anastomotic leak

研究概览

简要总结

To study the diagnostic specificity and sensitivity of various modalities used for the assessment of anastomotic leak in esophagogastric surgery and to identify the most sensitive technique. Secondarily, to propose a clinical algorithm to guide clinicians in the diagnosis of anastomotic leaks esophagogastric surgeries.

详细描述

Anastomotic leak in esophagogastric surgery remains a diagnostic challenge despite advances in imaging techniques. All available modalities appear to have limited sensitivities and have significant false negatives. A high index of clinical suspicion continues to be the key element in the early diagnosis of esophagogastric anastomotic leaks. The incidence of anastomotic leak in esophagogastric surgeries is reported to range from 7-20% in various studies, and it is a major complication that increases hospital stay and mortality. It is important to identify these complications early to optimize the outcomes of these patients. There has been no study till date that examines the incidence of false negative results for anastomotic leak in esophagogastric surgeries. False negative findings may give surgeons a false sense of assurance in the patient's postoperative recovery, and escalation of oral intake may result in catastrophic complications and outcomes in these patients. This study seeks to identify the most sensitive modality in the diagnosis of esophagogastric anastomotic leaks in a retrospective series of patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Patients undergoing any of the following surgeries at National University Hospital, Singapore between January 2001 and March 2019:
  • Distal gastrectomies
  • Total gastrectomies
  • Bariatric gastric bypasses
  • Subtotal esophagectomies
  • Proximal gastrectomies
  • Palliative bypasses
  • Total esophagectomies

排除标准

  • Under 21 years of age

结局指标

主要结局

Anastomotic leak

时间窗: Surgery day

To identify key clinical parameters that are predictive of anastomotic leak and to evaluate the effectiveness of various investigations for diagnosing anastomotic leak following upper gastrointestinal surgeries involving anastomosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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