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临床试验/NCT04308525
NCT04308525Unknown不适用

Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers - Enhanced Recovery and Improved Clinical Pathway

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
Length of stay (LOS)

研究概览

简要总结

This study aims to improve the peri- and postoperative care regimen for patients undergoing microvascular reconstruction after head and neck cancer by introducing an enhanced recovery after surgery (ERAS) programme.

详细描述

Advanced stage head and neck cancers have a poor prognosis and a 5-year survival rate of as low as 35-37%. The treatment is complex and often requires a multidisciplinary approach including surgery. The goal besides removal of the cancer is to restore function and appearance. If possible, both resection as well as immediate reconstruction will be performed during the same surgical procedure. Due to the large bone- and soft tissue loss following the ablative procedure, local solutions are often inadequate for reconstruction. In addition, many patients require post-operative radiotherapy, which may result in tightness of scar tissue and impaired function. In these cases it is necessary to perform the reconstruction using a free flap.

Free flap reconstruction involves tissue taken from other parts of the body, that is transplanted along with the associated blood vessels to the reconstruction site. The vessels of the flap are usually anastomosed to the vessels of the neck (microvascular reconstruction) and the transplanted tissue thereby obtains a blood supply at its new location. Head and neck cancer patients are usually reconstructed using the free fibular flap, the latissimus dorsi flap, the radial forearm flap or the anterolateral thigh flap.

The combination of complicated surgery and often malnourished patients with a low body mass index (BMI), that typically suffer from tobacco and alcohol abuse, commonly lead to postoperative ICU treatment and complications. The most common are infections, re-operations, delayed wound healing and refeeding syndrome, which is reported in up to 35% of patients undergoing major surgery for head and neck cancer.

Even with successful reconstruction, many patients suffer from drooling, lack of adequate clenching, permanent gastric tube feeding, insufficient wound healing and a high recurrence rate. Enhanced recovery after surgery (ERAS) is a peri- and postoperative care concept designed to accelerate recovery and improve convalescence. It has previously been established as superior to conventional care for a wide variety of procedures. As one of the first departments in the world our department has successfully implemented an ERAS program for microsurgical patients that undergo breast reconstruction using autologous tissue. By utilizing our experience with ERAS and combining it with a review of our own patient data we have developed an ERAS protocol for microvascular reconstruction after ablative surgery for head and neck cancer.

研究设计

研究类型
Observational
观察模型
Cohort
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 eligible for ablative surgery for head and neck cancer with primary microvascular reconstruction.

排除标准

  • Patients with conditions leading to increased risk of thromboembolic events
  • Patients pre-operatively admitted to the ICU

结局指标

主要结局

Length of stay (LOS)

时间窗: 1 to 4 weeks

Time from surgery to discharge

次要结局

  • Time to ambulation(1-7 days)
  • Complication-rate(30 days)
  • ICU LOS(1-2 days)
  • Incidence of re-operations(30 days)
  • Incidence of infections(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jens Hjermind Højvig

M.D., Ph.D.-student

Rigshospitalet, Denmark

研究点 (1)

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