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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

RecruitingNAAges 18 Years - anyAllKlinički Bolnički Centar Zagreb
NCT06493812 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 to investigate and compare the effectiveness and safety of using fascia lata and temporal muscle fascia in the reconstruction of the skull base in the sellar region. Specifically, the study aims to determine and compare the level of donor site pain between the two groups using Visual Analogue Scales (VAS). The study also aims to identify the optimal method and materials for skull base reconstruction that result in the lowest frequency of complications, thereby reducing perioperative morbidity and enabling earlier rehabilitation of patients. Subjects and Methods: Study Design: Prospective randomized controlled trial. Population: The study will enroll 68 patients who have undergone endoscopi

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. \*\*Age\*\*: Adult patients (18 years and older). 2. \*\*Surgical Requirement\*\*: Patients undergoing endoscopic endonasal surgery for sellar region tumors requiring reconstruction of the sellar floor to prevent postoperative cerebrospinal fluid (CSF) leaks. 3. \*\*Consent\*\*: Patients who provide informed consent to participate in the study. Exclusion Criteria: * 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.
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What it tests

  • Fascia lata
  • Temporal fascia
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Where

1 site
KBC Zagreb
Zagreb, Croatia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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