Transpterygoid Approaches

January 15, 2018 updated by: Ahmed El-Rahman Mohamed Azzam, Assiut University

Endoscopic Endonasal Transpterygoid Approaches

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.

Study Overview

Status

Unknown

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  1. Medically unfit patients for surgery
  2. In case of distant metastasis in tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patients
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
All patients will be operated by transpterygoid approaches which is classified into 5 major types.Type A involves thinning of the pterygoid process to access to Pterygopalatine fossa. Type B involves the removal of the medial and anterior aspect of the base of the pterygoid process to access the lateral recess of sphenoid sinus. Type C involves removing the base of the pterygoid plates to reach the petrous apex, Meckel's cave, or cavernous sinus. Type D requires removal of the pterygoid plates to access the infratemporal fossa. Type E requires the removal of the medial pterygoid plate or the entire pterygoid process, and the medial third of the Eustachian tube to acessof the lateral nasopharynx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of the pathology
Time Frame: 1 week
Identification of the type lesion will be made.
1 week
Frequency of residual mass
Time Frame: 1 week
Early MRI will be obtained after a week to asses the extent of resection and search if there is residual mass.
1 week
Frequency of recurrence
Time Frame: 6 months
Imaging will be done in six months period to search for any recurrence.
6 months
Frequency of complication
Time Frame: 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.
1 month
Operation time
Time Frame: intraoperative
The time of the operation will be calculated in this endoscopic approach comparing to traditional open technique.
intraoperative
Intraoperative bleeding
Time Frame: Intraoperative
The amount of intraoperative bleeding and the ability to control it.
Intraoperative
Surgical field exposure
Time Frame: 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.
Intraoperative
Post-operative stay
Time Frame: 2 weeks
post-operative stay of the patient in hospital.
2 weeks
mortality rate
Time Frame: 1 year
any deaths
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mohammed Shaker Abd-Elaal, MD, Assiut University
  • Principal Investigator: Hossam El-din Mahmoud El-Bosraty, MD, Cairo University
  • Study Director: Mohamed Modather Abd El-Naam, MD, PHD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

January 15, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 15, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • transpterygoid approaches

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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