跳至主要内容
临床试验/CTRI/2019/07/020084
CTRI/2019/07/020084尚未招募3 期

Intraoperative nerve monitoring of marginal mandibular nerve during neck dissection

NA1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年7月15日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
PRESENCE OF MARGINAL MANDIBULAR NERVE PARESIS

研究概览

简要总结

Marginal mandibular nerve injury is a complication that causes anaesthetic deficit that has a great impact on the patient’s perception ofappearance, inevitably influencing quality of life.1,2The reason forthis deficit is loss of innervation of depressor angulioris, depressor labii inferioris,mentalis, and orbicularis oris muscles, causing inability to move the lower lipdownward or laterally.3 The consequent cosmetic deficit, manifestinglower lip asymmetry and imbalance, is especially noticeable when opening themouth and is most obvious when the patient cries.2,4Because thecondition of the neck lymph nodes is the single most important prognosticfactor in carcinoma of the upper digestive airways, neck dissection has becomeordinary clinical practice in head and neck oncologic surgery.5

The main cause of nerve injury is that the marginal mandibular nerve hasa highly variable anatomy that cannot ensure reliable anatomic landmarks.

Nerve integrity monitoring (NIM) is a technique that monitors muscleactivity as a reflection of nerve function during surgery. The benefits ofelectromyographic monitoring for nerve preservation have been well establishedin many ear, nose, and throat (ENT) surgeries; however, its use is stilldebated in other procedures. The purpose of this study will be to assess theusefulness of NIM as an aid to reduce the incidence of marginal mandibularnerve paralysis after neck dissection, also to consider its possible impact oncosts and surgical time.

In our institution , among 74 patients with stage T1/T2 per primumcarcinoma tongue operated for per-oral wide local excision of tongue withunilateral neck dissection within January 2017 to June 2018, there is anincidence of around 58 % patients having temporary marginal paresis in the postoperative period and on follow up of minimum 3 months and more, around 32 % arestill having marginal nerve paresis i.e permanent nerve paresis

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
15.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •stage T1/T2/T3 per primum tongue carcinoma patients 2) primary defect can be closed with primary closure.

排除标准

  • •patients received prior chemotherapy or radiotherapy 2)prior neck surgeries 3)requiring bilateral neck dissection 4)pre-operative facial weakness 5)patients requiring lower cheek flap/angle split incision 6)requiring mandibular resection or mandibulotomy for approach 7)patients requiring free flap/pedicled flap reconstruction 8)requiring nerve sacrifice for oncological margins.

结局指标

主要结局

PRESENCE OF MARGINAL MANDIBULAR NERVE PARESIS

时间窗: post operative day 1/2

次要结局

  • OVERALL SURGICAL COST(IMMEDIATE POST SURGERY)
  • OVERALL SURGICAL TIME(IMMEDIATE POST NECK DISSECTION)
  • PRESENCE OF MARGINAL MANDIBULAR NERVE PARESIS(AT 3 MONTHS, 6 MONTHS AND A YEAR OF FOLLOW-UP)

研究者

发起方
NA
申办方类型
Other [na]

研究点 (1)

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