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

NCT03448614 | Unknown

• 1 other identifier: skull base reconstruction
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Skull Base Neoplasms

Keywords

skull base reconstrction

Outcome Measures

Primary Outcomes (4)

• Head CT scan

  bone window axial, coronal and sagittal cuts to measure preoperative skull base defect size

  within 1month preoperative

• brain MRI: with and without contrast

  Coronal, axial and sagittal MRI in T1 and T2 signals measures postoperative tumor, to assess the repaired defect after the surgery

  within1 week post operative

• brain MRI: with and without contrast

  Coronal, axial and sagittal MRI in T1 and T2 signals to assess the repaired defect after the surgery

  3 monthes post operative

• brain MRI: with and without contrast

  Coronal, axial and sagittal MRI in T1 and T2 signals to assess the repaired defect after the surgery, recurrence of tumor

  6monthes postoperative

Secondary Outcomes (6)

• estimation of incidence of sinonasal, orbital &/or intracranial complications

  within 90 days following surgery

• the incidence of CSF leakage

  within 90 days postoperative

• CSF leakage related surgical intervention

  within 90 days postoperative

• Endonasal endoscopic evaluation of the grafted defect

  within 1 month postoperative, 3monthes postoperative

• Brain MRI: with and without contrast

  within 1 month preoperative

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patient will undergo endonasal cranio-endoscopic resection

You may qualify if:

• All patients undergoing endonasal cranio-endoscopic resection

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (10)

• Kassam A, Snyderman CH, Mintz A, Gardner P, Carrau RL. Expanded endonasal approach: the rostrocaudal axis. Part I. Crista galli to the sella turcica. Neurosurg Focus. 2005 Jul 15;19(1):E3.

  PMID: 16078817 BACKGROUND

• Kassam A, Snyderman CH, Mintz A, Gardner P, Carrau RL. Expanded endonasal approach: the rostrocaudal axis. Part II. Posterior clinoids to the foramen magnum. Neurosurg Focus. 2005 Jul 15;19(1):E4.

  PMID: 16078818 BACKGROUND

• Kassam AB, Gardner P, Snyderman C, Mintz A, Carrau R. Expanded endonasal approach: fully endoscopic, completely transnasal approach to the middle third of the clivus, petrous bone, middle cranial fossa, and infratemporal fossa. Neurosurg Focus. 2005 Jul 15;19(1):E6.

  PMID: 16078820 BACKGROUND

• Kassam A, Carrau RL, Snyderman CH, Gardner P, Mintz A. Evolution of reconstructive techniques following endoscopic expanded endonasal approaches. Neurosurg Focus. 2005 Jul 15;19(1):E8.

  PMID: 16078822 BACKGROUND

• Snyderman CH, Kassam AB, Carrau R, Mintz A. Endoscopic Reconstruction of Cranial Base Defects following Endonasal Skull Base Surgery. Skull Base. 2007 Feb;17(1):73-8. doi: 10.1055/s-2006-959337.

  PMID: 17603646 BACKGROUND

• Sigler AC, D'Anza B, Lobo BC, Woodard TD, Recinos PF, Sindwani R. Endoscopic Skull Base Reconstruction: An Evolution of Materials and Methods. Otolaryngol Clin North Am. 2017 Jun;50(3):643-653. doi: 10.1016/j.otc.2017.01.015. Epub 2017 Mar 31.

  PMID: 28372814 BACKGROUND

• Villaret AB, Schreiber A, Battaglia P, Bignami M. Endoscopy-assisted iliotibial tract harvesting for skull base reconstruction: feasibility on a cadaveric model. Skull Base. 2011 May;21(3):185-8. doi: 10.1055/s-0031-1275260.

  PMID: 22451823 BACKGROUND

• Zanation AM, Thorp BD, Parmar P, Harvey RJ. Reconstructive options for endoscopic skull base surgery. Otolaryngol Clin North Am. 2011 Oct;44(5):1201-22. doi: 10.1016/j.otc.2011.06.016.

  PMID: 21978902 BACKGROUND

• Hadad G, Bassagasteguy L, Carrau RL, Mataza JC, Kassam A, Snyderman CH, Mintz A. A novel reconstructive technique after endoscopic expanded endonasal approaches: vascular pedicle nasoseptal flap. Laryngoscope. 2006 Oct;116(10):1882-6. doi: 10.1097/01.mlg.0000234933.37779.e4.

  PMID: 17003708 BACKGROUND

• El-Sayed IH, Roediger FC, Goldberg AN, Parsa AT, McDermott MW. Endoscopic reconstruction of skull base defects with the nasal septal flap. Skull Base. 2008 Nov;18(6):385-94. doi: 10.1055/s-0028-1096202.

  PMID: 19412408 BACKGROUND

MeSH Terms

Conditions

Skull Base Neoplasms

Condition Hierarchy (Ancestors)

Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• ahmed G sholkamy, Msc

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: February 28, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

EG (1)