An observational study in Skull Base Neoplasms, sponsored by Assiut University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Assiut University · Observational
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
Type of the study:
A prospective clinical study will be conducted in the period between January 2018 and January 2020.
Study Setting:
Otolaryngology Department, Alexandria University Hospital. Otolaryngology Department, Assiut University Hospital.
Study tools :
Preoperative evaluation:
Radiological assessment:
Assessment of the general condition of the patient:
Operative techniques:
After cranio-endoscopic resection and complete removal of the lesion skull base defect will be repaired according to the following scheme (modified from Sigler et al) No leak →No repair or single layer Low-flow leak → Multilayer repair Autograft (fascia Lata, fat, bone, mucosa) High-flow leak →Multilayer repair Autograft (fascia Lata, fat, bone, mucosa)+ Intranasal vascularized flap.
Modifying factors (factors that indicate the need for a vascularized flap regardless of leak type): Cushing disease, morbid obesity, craniopharyngioma, meningioma, extended skull base approach, large defect, revision surgery, history of or future need for radiation treatment.
So repair technique after extensive dural and bony resection or high flow leak will include multiple layers of fascia lata with pieces of fatty tissue in between. After that, a nasoseptal flap (or other vascularized flap, e.g., posterior pedicled inferior turbinate, posterior pedicled middle turbinate, bipedicled anterior septal, anterior inferior turbinate) will be harvested and applied according to local vascularity.
Then a separator will be applied; to prevent future accidental dislodgement of grafts during Merocel® removal, followed by placement of a moderately inflated Foley balloon catheter; to support the reconstruction.
At the end of the procedure, when hemostasis will be achieved, irrigation will be performed to remove any bone residuals or blood clots from the choanae and the nasopharynx. Then, the middle turbinates will be gently repositioned medially. At last, nasal Merocel® (polyvinyl alcohol) sponges will be placed in the nasal cavity on either side and hydrated with saline to expand.
Repair of low flow leak will be the same as the previous technique with the replacement of the vascularized flap with free mucosal graft and no need for Foley catheter.
Early postoperative management:
For the next twenty-four hours, the patient will be monitored in the intensive care unit, particularly for diabetes insipidus (after pituitary surgery), visual deterioration, any CSF leak, manifestations of meningitis or any hemorrhage.
Inspection for CSF leak will be a part of the routine evaluation of every patient, both in the recovery room and in the days after surgery. If persistent CSF leak became evident, a lumbar drainage was tried before re-exploration under general anesthesia. Analgesics will be routinely prescribed. Prophylaxis against postoperative nausea and vomiting will be achieved by an intraoperative intravenous administration of a single dose of an antiemetic, ondansetron 4 mg, as well as a throat pack to prevent intraoperative bleeding from draining into the stomach.
An intravenous third-generation cephalosporin will be started with anesthesia induction and continued until removal of the nasal packing. Then, patients will be kept on a five days course of an oral antibiotic; for safety.
Nasal packs will be removed on the third or fifth postoperative day. Then, the patient will be examined under endoscopic guidance.
Follow up:
I. Otorhinolaryngologic assessment: The first office visit will be scheduled after a week following the surgery. After application of topical anesthesia (lidocaine 10%), any blood clots will be endoscopically removed and any synechiae will be released. The examination will be for any bleeding or CSF leakage. The patient will be seen on a weekly basis for the first three weeks and then every three weeks for the next two appointments. Healing usually occurs three to six weeks. Further appointments will be scheduled as necessary II. Neuro-radiological assessment: Early MRI will be obtained on the first or second postoperative day to assess the extent of resection, the location of the fat graft if one is present, and the presence of any hematoma. Serial imaging was done after six months and then annually.
III. Endocrinal assessment: in case of hypophysectomy. IV. Ophthalmological assessment: serial visual field, visual acuity, and fundus examinations will be done for every patient, especially those with a pre-operative visual loss.
20 studies on the registry are indexed under Skull Base Neoplasms; 7 are open to participants now.
Browse Skull Base Neoplasms studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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all patient will undergo endonasal cranio-endoscopic resection
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Head CT scan
bone window axial, coronal and sagittal cuts to measure preoperative skull base defect size
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6monthes postoperative
estimation of incidence of sinonasal, orbital &/or intracranial complications
identification of possible complication that will occur during resection of skull base and removal of tumors
Time frame: within 90 days following surgery
the incidence of CSF leakage
history of CSF leakage confirmed by endoscopic examination
Time frame: within 90 days postoperative
CSF leakage related surgical intervention
second surgical intervention to explore the grafted defect
Time frame: within 90 days postoperative
Endonasal endoscopic evaluation of the grafted defect
using 4 mm 0-degree endoscope to measure graft condition and visualize any CSF fistula
Time frame: within 1 month postoperative, 3monthes postoperative
Brain MRI: with and without contrast
Coronal, axial and sagittal MRI in T1 and T2 signals measures preoperative tumor size
Time frame: within 1 month preoperative
type of pathology
identification of the type of the pathology
Time frame: within 1 week post operative
Started Jan 2018 (actual). Primary completion is estimated for Jan 2019, 12 months after the start.
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