跳至主要内容
临床试验/NCT06140160
NCT06140160招募中不适用

Anterior Thoracic Perforating Artery (PATA); Systematization and Applications in Reconstructive Surgery of the Head and Neck

Ramsay Générale de Santé2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
2
主要终点
Existence of the anterior thoracic perforating artery

研究概览

简要总结

The use of cutaneous or fasciocutaneous flaps is daily in reconstructive surgery ENT in patients with cancers of the upper aero-digestive tract (AVDS). Cancers of the oral cavity require reconstructions with thin flaps in order to best preserve the functions of swallowing and phonation via patients' joints. Indeed, the flaps are inert tissues, which can only be mobilized by the residual muscles of the patients' tongue: their lightness and finesse facilitates this mobilization. The use of free flaps is regular but requires micro-surgical skill of the operator as well as a preserved general condition of the patients and appropriate post-operative care. Alternatively, there are some pedicled flaps with the appropriate thickness to reconstruct extensive loss of substances from the oral cavity in a suitable manner: the supraclavicular flap, the suprahyoid flap, the submental flap and the myo-mucosal flap pedicled on the facial artery being more limited in size. The creation of an anterior thoracic fasciocutaneous flap, pedicled on the anterior thoracic perforating artery (PATA) seems to be another suitable therapeutic option. Only one preliminary Chinese study describes it, on only eleven patients. According to the authors, it would offer a wide skin palette (up to 15x10cm). Its long pedicle (on average 9.2cm) would allow a significant axis of rotation so that the flap easily reaches the oral cavity. The authors underline the variability of the origin of this perforator, arising depending on the case from the transverse cervical trunk (9 cases) or from the supraclavicular artery (2 cases), branches of division of the thyro-cervical trunk.

However, when the PATA arises from the supraclavicular artery, its interest could be limited because the creation of a PATA perforator flap could compromise the creation of a secondary supraclavicular flap.

Thus, this study aims to clarify the feasibility of harvesting the PATA flap in the greatest number of patients. The objective is to study the variations of the anterior thoracic perforating artery necessary for the creation of this flap, by specifying its vascularization territory and its characteristics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

  • Patient, man or woman over 18 years old,
  • Patient admitted for an indication for Doppler ultrasound of the supra-aortic trunks (previously prescribed for any medical reason),
  • Patient having received written information and collection of the non-opposition of the patient to participate in the study,
  • Patient affiliated or beneficiary of a security regime social.

排除标准

  • Minor patient,
  • History of cervical surgery,
  • Patients who have an inaccessible morphology to an exploration of the lower lateral cervical region, high, below and above the right and left clavicle such as the small necks, and/or with dermato-sclerosis,
  • Patients who do not have the intellectual or physical allowing them to give their consent,
  • Patient in period of exclusion due to another research still in progress at the time of inclusion,
  • Refusal to participate in the patient's study,
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative,
  • Pregnant, breastfeeding or parturient woman,
  • Patient hospitalized without consent.

结局指标

主要结局

Existence of the anterior thoracic perforating artery

时间窗: 1 hour

existence of the anterior thoracic perforating artery (PATA) : yes/no

Presence of the anterior thoracic perforating artery

时间窗: 1 hour

the presence of the anterior thoracic perforating artery on the left and right,

Origin of anterior thoracic perforating artery

时间窗: 1 hour

Origin of anterior thoracic perforating artery : transverse cervical trunk/ supraclavicular artery

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 (2)

Loading locations...

相似试验

Anterior Thoracic Perforating Artery (PATA);... | 临床试验