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临床试验/NCT03406442
NCT03406442Unknown不适用

Endoscopic Endonasal Transpterygoid Approaches

Assiut University0 个研究点目标入组 25 人开始时间: 2018年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
25
主要终点
Type of the pathology

研究概览

简要总结

To identify:

  1. The most frequent pathologies affecting pterygopalatine fossa, lateral recess of the sphenoid sinus, petrous apex, Meckel's cave, cavernous sinus, infratemporal fossa and lateral nasopharynx that can be treated by endonasal endoscopic transptergoid approaches, the most common presenting manifestations and indication of surgery.
  2. The different techniques and feasibility of different endonasal endoscopic transpterygoid approaches and the frequency of utilization of approach.
  3. Try to establish a protocol for post-operative care and management of complications.
  4. Obtain sufficient surgical experience in endonasal endoscopic transpterygoid surgery to establish endonasal endoscopic skull-base surgery in Assiut University Hospital.

详细描述

Skull base surgery has undergone dramatic advances. During early stages, the endoscopic approaches were limited by the resultant skull base defects .

Access to the pterygopalatine fossa (PPF) is a surgical challenge due to its deep location in the mid-third of the face and its complex array of vascular and neural structures. An important aspect of the PPF is its topographical relation to the orbit and cranial cavity.

The philosophy behind the transpterygoid approach centers on the maxillary sinus as the primary corridor, displaces the contents of the PPF and removes the pterygoid process partially or completely to reach to the lateral extent of the endonasal technique.

The endoscopic endonasal transpterygoid approaches classified into five types. Type A involves thinning of the pterygoid process to gain access to PPF. Type B involves removal of the medial and anterior aspect of the base of the pterygoid process to access the lateral recess of the sphenoid sinus. Type C involves dissecting the vidian nerve to identify the petrous ICA and removing the base of the pterygoid plates to reach the petrous apex, Meckel's cave, or cavernous sinus. Type D requires a variable removal of the pterygoid plates to access the infratemporal fossa. Type E requires removal of part or even the entire pterygoid process, and the medial third of the Eustachian tube to provide exposure of the lateral nasopharynx.

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

  • Any patient with lesions affecting pterygopalatine fossa, lateral recess of the sphenoid sinus, petrous apex, Meckel's cave, cavernous sinus, infratemporal fossa and lateral nasopharynx that can be treated by endonasal endoscopic transptergoid approaches.

排除标准

  • Medically unfit patients for surgery
  • In case of distant metastasis in tumors

研究组 & 干预措施

patients

Other

The patient who have lesions affecting pterygopalatine fossa, lateral recess of the sphenoid sinus, petrous apex, Meckel's cave, cavernous sinus, infratemporal fossa and lateral nasopharynx and can be treated by endonasal endoscopic transptergoid approaches

干预措施: Transpterygoid approaches (Procedure)

结局指标

主要结局

Type of the pathology

时间窗: 1 week

Identification of the type lesion will be made.

Frequency of residual mass

时间窗: 1 week

Early MRI will be obtained after a week to asses the extent of resection and search if there is residual mass.

Frequency of recurrence

时间窗: 6 months

Imaging will be done in six months period to search for any recurrence.

Frequency of complication

时间窗: 1 month

Post-operative follow up of the patients will be done to identify the frequency of complication either rhinogenic as bleeding , synechiae, csf leakage or orbital complication as proptosis, visual affection or intracranial complication as meningitis.

Operation time

时间窗: intraoperative

The time of the operation will be calculated in this endoscopic approach comparing to traditional open technique.

Intraoperative bleeding

时间窗: Intraoperative

The amount of intraoperative bleeding and the ability to control it.

Surgical field exposure

时间窗: Intraoperative

The possibility of the approach to reach lesions affecting deep area in the skull as pterygopalatine fossa, lateral recess of the sphenoid sinus, petrous apex, Meckel's cave, cavernous sinus, infratemporal fossa and lateral nasopharynx.

Post-operative stay

时间窗: 2 weeks

post-operative stay of the patient in hospital.

mortality rate

时间窗: 1 year

any deaths

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

Ahmed El-Rahman Mohamed Azzam

Dr.Ahmed EL-rahman Mohamed Azzam, Assistant lecture of otorhinolaryngology department

Assiut University

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