Comparing two types of fascia for skull base reconstruction after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• KBC Zagreb
  Zagreb, Croatia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.