Comparing two types of fascia for skull base reconstruction after surgery
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
This study is testing whether using fascia from the thigh or from the temple is better for repairing the skull base after surgery for certain tumors, to see which one leads to less pain and fewer complications for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Klinički Bolnički Centar Zagreb Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT06493812 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of using fascia lata versus temporal muscle fascia for reconstructing the skull base in patients who have undergone endoscopic endonasal surgery for sellar region tumors. The study aims to assess donor site pain levels using Visual Analogue Scales (VAS) and to identify which graft material leads to fewer complications and better patient outcomes. A total of 68 adult patients will be enrolled and randomly assigned to receive one of the two types of fascia for reconstruction. The goal is to enhance surgical recovery and quality of life by minimizing complications such as cerebrospinal fluid leaks.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older who are undergoing endoscopic endonasal surgery for sellar region tumors requiring reconstruction.
Not a fit: Patients without an intraoperative cerebrospinal fluid leak or those with prior radiation therapy to the operative site may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing skull base reconstruction.
How similar studies have performed: While there have been studies on graft materials for skull reconstruction, this specific comparison of fascia lata and temporal fascia is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Zagreb
- KBC Zagreb — Zagreb, Croatia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.