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

Launched by KLINIČKI BOLNIČKI CENTAR ZAGREB · Jun 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for repairing a part of the skull called the sellar region after surgery. Researchers want to find out which method is better: using a patch from the thigh (called fascia lata) or from the side of the head (called temporal muscle fascia). The main goal is to see how much pain patients feel at the site where the patch was taken from and to check for complications after surgery, such as infections or leaks of cerebrospinal fluid, which is the fluid that surrounds the brain and spinal cord.

If you are an adult 18 years or older and are having surgery for tumors in the sellar region, you might be eligible to participate in this study. To join, you'll need to agree to be part of the trial and not have any issues at the site where the patch will be taken from. Participants will undergo one of the two surgical methods and will be monitored for pain and any problems over the weeks following the surgery. This study aims to help doctors choose the safest and most effective way to repair this part of the skull, which could lead to quicker recovery and better quality of life for patients.

Gender

ALL

Eligibility 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.