跳至主要内容
临床试验/NCT07059195
NCT07059195招募中不适用

Non-Invasive Techniques to Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection

Sohag University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
cervical spine flexion

研究概览

简要总结

Tracheal surgery represents a relatively recent advancement in the field of thoracic surgery. The trachea has unique anatomical and physiological challenges that historically rendered surgical manipulation both risky and limited. Early interventions involving the trachea were primarily restricted to emergency tracheostomy procedures, typically performed as life-saving measures during acute airway obstruction (1). Attempts at tracheal reconstruction were largely unsuccessful due to the absence of suitable anesthesia, inadequate surgical tools, and the prevailing belief that tracheal cartilage lacked sufficient regenerative. As a result, tracheal resection and reconstruction were long considered unfeasible (2).

The modern era of tracheal surgery began to take shape in the mid-20th century. While early attempts at tracheal resection were performed with limited success, it was the pioneering work of Dr. Hermes C. Grillo in the 1960s that truly transformed the field. Through systematic study of tracheal anatomy, vascular supply, and biomechanics, Dr. Grillo developed standardized and safe techniques for segmental tracheal resection followed by primary end-to-end anastomosis. His work demonstrated that segmental resection of the trachea followed by primary end-to-end anastomosis was feasible and safe (3)(4).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All pediatric and adult patients undergoing tracheal and cricotracheal resection for benign air way stenosis
  • •All pediatric and adult patients undergoing tracheal and cricotracheal resection for malignant pathologies

排除标准

  • •patients with previous cervical spine surgery.
  • •Congenital or acquired spinal deformities.

研究组 & 干预措施

• Group A (Non-invasive group)

Active Comparator

Patients in this group will have postoperative cervical spine flexion maintained using non-invasive techniques, such as a cervical collar or cervical-thoracic orthosis.

干预措施: cervical collar or cervical-thoracic orthosis. (Procedure)

• Group B (Conventional group)

Active Comparator

Patients in this group will have cervical spine flexion maintained using traditional chin-to-chest (Grillo) suturing

干预措施: chin-to-chest (Grillo) suturing (Device)

结局指标

主要结局

cervical spine flexion

时间窗: 2 years

Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection

次要结局

未报告次要终点

研究者

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

Abdelrahman Talal Mahomud

Assisstent lecturer at cardiothorathic department

Sohag University

研究点 (1)

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