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临床试验/NCT03440151
NCT03440151Unknown不适用

Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma (Randomize Noninferiority Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年2月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
64
试验地点
1
主要终点
local recurrence

研究概览

简要总结

The purpose of this study is to compare the oncological and functional results of the contralateral submental flap with primary closure for reconstruction of tongue squamous cell carcinoma.

详细描述

Resection of tongue malignancies remains one of most surgical challenges because of its adverse effects on speech articulation, swallowing, and eventual quality of life.

A variety of local flaps such as infrahyoid flap and the Platysma flap, and free flaps like the radial forearm and anterolateral thigh (ALT) flap have been available for reconstruction of tongue. However, all these options have their shortcomings.

When reconstructing particular oral cavity defect the tissue used should be reliable; functional and cosmetically acceptable with minimum donor site morbidity and match the recipient site in terms of color, texture and thickness. The submental island flap (SMI-flap) which has been first introduced by Martin et al in 1990, meets all these requirements and due to its optimal location, ease of harvest, and favorable arc of rotation, the SMI-flap has gained acceptance as a simple, reliable and convenient to repair defects of tongue and oral cavity cancer.

The oncological safety of submental flap in oral cancer patient still debate, this is due to its proximity to the main nodal basins of levels 1A and 1B and the possibility of transfer of occult metastatic lymph node to the recipient site during reconstruction.

in addition some authors has not been recommended submental flap for cases with clinically or radiologically established nodal disease as it might compromise the oncological resection and continuity of neck dissection and so alternative options should be considered. The contralateral submental island flap (CSMI-flap) is believed to offer such alternate option for patient with contralateral negative node.

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

盲法说明

Because the two interventions used in this trial are clearly different and easly recognized by the participants and investigators, neither investigators nor Participants can be blinded.

The statistician will be blinded.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient with T1&T2 tongue squamous cell carcinoma.

排除标准

  • Patients with contralateral N positive.
  • Patients with previous neck surgery that interrupt contralateral facial artery or vein.
  • Patients with prior radiotherapy to the neck.
  • Patients with lesions crossing the midline, or those reaching the base of tongue requiring total glossectomy.
  • Patients second primary tumors at the time of diagnosis.
  • Patient with recurrent tongue squamous cell carcinoma.

结局指标

主要结局

local recurrence

时间窗: at least one year post operative

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

Omer mohammed jamali

principal investigator

Cairo University

研究点 (1)

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