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Skull Base Reconstruction After Endonasal Cranio-endoscopic Resection Using Autologus Grafts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03448614
Recruitment Status : Unknown
Verified February 2018 by Ahmed Gamal Sholkamy, Assiut University.
Recruitment status was:  Active, not recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Gamal Sholkamy, Assiut University

Brief Summary:
Endonasal endoscopic approach to the skull base has been expanded in the last several years owing to advances in the radiological aspect that provided a better evaluation of the lesions and the surrounding structures, technological advances that include angled endoscope, development of high-resolution cameras, high definition monitors and navigation systems and better anatomical experience. The endoscopic endonasal approach now provides access to frontal sinus to the second cervical vertebra in the sagittal plane and from the sella to the jugular foramen in the coronal plane. Endoscopic resection of large skull base tumors results in large defect for which repair is a challenge. Several factors besides the size of the defect should be considered during skull base repair as CSF leak, CSF pressure, history or need for future radiotherapy, lack of support and local tissue vascularity. The aim of this study is to Provide an algorithmic approach for skull base reconstruction after endonasal cranio-endoscopic resection using autologous grafts according to the extent of resection, skull base defect size, the presence of CSF leak, CSF pressure and local tissue vascular

Condition or disease
Skull Base Neoplasms

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Skull Base Reconstruction After Endonasal Cranio-endoscopic Resection Using Autologus Grafts
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Head CT scan [ Time Frame: within 1month preoperative ]
    bone window axial, coronal and sagittal cuts to measure preoperative skull base defect size

  2. brain MRI: with and without contrast [ Time Frame: within1 week post operative ]
    Coronal, axial and sagittal MRI in T1 and T2 signals measures postoperative tumor, to assess the repaired defect after the surgery

  3. brain MRI: with and without contrast [ Time Frame: 3 monthes post operative ]
    Coronal, axial and sagittal MRI in T1 and T2 signals to assess the repaired defect after the surgery

  4. brain MRI: with and without contrast [ Time Frame: 6monthes postoperative ]
    Coronal, axial and sagittal MRI in T1 and T2 signals to assess the repaired defect after the surgery, recurrence of tumor


Secondary Outcome Measures :
  1. estimation of incidence of sinonasal, orbital &/or intracranial complications [ Time Frame: within 90 days following surgery ]
    identification of possible complication that will occur during resection of skull base and removal of tumors

  2. the incidence of CSF leakage [ Time Frame: within 90 days postoperative ]
    history of CSF leakage confirmed by endoscopic examination

  3. CSF leakage related surgical intervention [ Time Frame: within 90 days postoperative ]
    second surgical intervention to explore the grafted defect

  4. Endonasal endoscopic evaluation of the grafted defect [ Time Frame: within 1 month postoperative, 3monthes postoperative ]
    using 4 mm 0-degree endoscope to measure graft condition and visualize any CSF fistula

  5. Brain MRI: with and without contrast [ Time Frame: within 1 month preoperative ]
    Coronal, axial and sagittal MRI in T1 and T2 signals measures preoperative tumor size

  6. type of pathology [ Time Frame: within 1 week post operative ]
    identification of the type of the pathology



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all patient will undergo endonasal cranio-endoscopic resection
Criteria

Inclusion Criteria:

  • All patients undergoing endonasal cranio-endoscopic resection

Exclusion Criteria:

  • Unfit patient for surgery.
  • Patient refusal to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448614


Locations
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Egypt
Assiut University
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: ahmed G sholkamy, Msc Assiut University
Publications:

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Responsible Party: Ahmed Gamal Sholkamy, dr, Assiut University
ClinicalTrials.gov Identifier: NCT03448614    
Other Study ID Numbers: skull base reconstruction
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Gamal Sholkamy, Assiut University:
skull base reconstrction
Additional relevant MeSH terms:
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Skull Base Neoplasms
Skull Neoplasms
Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases