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临床试验/NCT03195101
NCT03195101Unknown不适用

Evaluation of Transconjunctival Approach in Management of Orbital Tumors

Assiut University0 个研究点目标入组 30 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
successfulness of the surgical procedure

研究概览

简要总结

Many surgical approaches for excision of orbital tumors have been described. These approaches do not allow access to all orbital quadrants. Furthermore, some of these approaches are technically difficult, associated with long morbidity and post operative pain, having high rate of complications or having unacceptable cosmetic appearance. the investigators present the transconjunctival approach as an alternative procedure that allows access to orbital tumors in different locations as well as less morbidity and better cosmetic results

详细描述

Orbital tumors are divided anatomically into intraconal and extraconal depending on their relationship with the muscle cone which is further classified into anterior and posterior orbital tumors. Excision of orbital tumors is considered a challenge for the surgeon. This is due to the complex structure of the orbit. The orbital cavity is narrow that does not allow adequate exposure. Furthermore, the orbit is full of vital structures which require careful manipulation. Many surgical approaches for excision of these tumors have been described. These approaches do not allow access to all orbital quadrants. Furthermore, some of these approaches are technically difficult, associated with long morbidity and post operative pain due to the osteotomy, having high rate of complications or having unacceptable cosmetic appearance. Few studies with limited number of patients have used transconjunctival approach in management of orbital tumors All patients with orbital tumor will be managed by the transconjunctival incisional or excisional biopsy according to the suggested nature of the tumor being benign or malignant as well as the site of the tumor using the clinicoradiological finding. In case of intraconal tumors, the mass will be approached via the transconjunctival approach but if the mass is out of reach via this approach, lateral orbitotomy approach will be used as an alternative procedure to perform the predetermined decision. This allows detection of the intraconal tumor criteria that could be excised safely via this approach

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with orbital tumor either benign or malignant.

排除标准

  • Patients with apical tumors not accessible with transconjunctival approach.
  • Patients with too anterior tumors (superficial dermoid and lacrimal gland swelling).
  • Patients with non-neoplastic orbital lesions.
  • Patients with follow up period of less than 3 months

结局指标

主要结局

successfulness of the surgical procedure

时间窗: every patient will be assessed 3 days postoperative

The procedure will be considered successful if the predetermined decision is achieved without sight threatening complications. The procedure will be considered a failure if the decision could not be achieved or if a sight threatening complication occurs.

次要结局

  • Early and late complications of the approach and their long term effects(3 days postoperative, 1 week, 1 month and 3 months postoperative.)

研究者

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

Ahmad Abdelnasser Awad

Principal Investigator

Assiut University

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