跳至主要内容
临床试验/NCT02612883
NCT02612883已完成不适用

Flux Measurement and Outcome in Major Abdominal Surgery

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2015年11月18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
137
试验地点
1
主要终点
Perioperative morbidity

研究概览

简要总结

Tissue perfusion is a critical factor for tissue regeneration and healing of anastomoses. Compromised microperfusion in the area where the anastomosis is sited likely contributes to leaks, but until now there has not been an easy and reliable technique to intraoperatively evaluate microperfusion.

Objectives: To assess the association of intraoperative flux measurement with postoperative outcome of patients undergoing major abdominal surgery.

Trial design: Prospective observational study. Flux measurement will be carried out using the moorVMS-LDF DUAL CHANNEL Laser Doppler Blood Flow system. The flux probe will be applied on the respective organs (i.e. esophagus, stomach, liver, pancreas, colon, rectum) and measurements will be documented after a stable signal has been obtained.

详细描述

Surgical resection is the primary therapy for a variety of benign and malignant diseases of the gastrointestinal tract. Advances in the perioperative care surgical technique and imaging modalities have significantly improved the outcome of patients with major abdominal resections within the past three decades. However, the incidence of postoperative complications after major abdominal resections remains high with morbidity rates of 30-60% despite a gradual decrease in perioperative mortality over time. Persistently high morbidity rates may in part be explained by broadened indications with surgery in patients having relevant comorbidities and/or advanced disease requiring extended resections. The reduction of perioperative morbidity is of high relevance for the patients, as complications are associated with poor oncological and functional long-term outcome and delay of further therapy. In addition, complications present a major cause of costs for the health care system.

Tissue perfusion is a critical factor for tissue regeneration and healing of anastomoses. Compromised microperfusion in the area where the anastomosis is sited likely contributes to leaks, but until now there has not been an easy and reliable technique to intraoperatively evaluate microperfusion.

During the post-operative period, inadequate wound perfusion and impairment of systemic or local oxygenation represent the main predisposing factors for anastomotic leakage. This is the case for the gastric conduit as well as for colonic/rectal anstomoses.

For example, the performance of gastroplasty has been shown to be associated with impairment in the microcirculatory blood flow in the proximal end of the gastric tube, despite the absence of significant impairment in systemic haemodynamic status.

These microcirculatory impairments promote the occurrence of oesophageal anastomotic leakage, which represents a potentially life-threatening complication related to the disastrous consequences of the leakage of gastrointestinal contents, with mediastinitis, septic shock, acute respiratory distress syndrome and death.

研究设计

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

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 scheduled for elective major abdominal surgery including
  • Liver resection
  • Esophageal resection
  • Gastric resection
  • Colon/rectal resection
  • Pancreatic resection

排除标准

  • Expected lack of compliance
  • Impaired mental state or language problems

结局指标

主要结局

Perioperative morbidity

时间窗: 90 days after resection

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)

Loading locations...

相似试验