Status:
RECRUITING
Comparison of Clinical Value in the Use of the Fascia Lata and Temporal Muscle Fascia in the Reconstruction of the Dura in the Sellar Region
Lead Sponsor:
Klinički Bolnički Centar Zagreb
Conditions:
Skull Defect
Transplant Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study Title: Assessing the Clinical Significance of Using Fascia Lata versus Temporalis Muscle Fascia for Skull Base Reconstruction in Sellar Region Objective: The primary objective of this study is ...
Detailed Description
Study Title: Assessing the Clinical Significance of Using Fascia Lata versus Temporalis Muscle Fascia for Skull Base Reconstruction in Sellar Region Study Objective: The primary objective of this pro...
Eligibility Criteria
Inclusion
- \*\*Age\*\*: Adult patients (18 years and older).
- \*\*Surgical Requirement\*\*: Patients undergoing endoscopic endonasal surgery for sellar region tumors requiring reconstruction of the sellar floor to prevent postoperative cerebrospinal fluid (CSF) leaks.
- \*\*Consent\*\*: Patients who provide informed consent to participate in the study.
Exclusion
- 1\. \*\*Donor Site Pathology\*\*: Presence of pathology at the donor site, including trauma or previous surgical interventions.
- 2\. \*\*Absence of Intraoperative CSF Leak\*\*: Patients without an intraoperative CSF leak requiring reconstruction.
- 3\. \*\*Alternative Reconstruction Methods\*\*: Use of reconstruction materials other than fascia lata or temporal fascia.
- 4\. \*\*Prior Radiation Therapy\*\*: Patients who have received prior radiation therapy to the operative or donor site.
- 5\. \*\*Medical Contraindications\*\*: Patients with medical conditions that contraindicate the surgical procedure or participation in the study.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2033
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06493812
Start Date
June 1 2023
End Date
December 1 2033
Last Update
July 11 2024
Active Locations (1)
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1
KBC Zagreb
Zagreb, Croatia, 10000