Internal nasal splint–supported free graft versus nasoseptal flap for repairing bilateral CSF leaks

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 interventional study compares two endoscopic skull base repair techniques for adults with confirmed bilateral CSF leaks: an internal nasal splint-supported free graft and a nasoseptal flap alone. Eligible participants will undergo endoscopic repair using one of the techniques and be followed with clinical exams, imaging, and biochemical testing to monitor leak closure and healing. The protocol emphasizes feasibility and outcomes in patients with septal abnormalities or prior septal surgery that may complicate flap harvest. Key outcomes include rate of CSF leak closure, need for revision surgery or CSF diversion, and procedure-related complications.

Why it matters

Who can join: the full rules

Inclusion Criteria: 1- Adults (≥18 years). 2- Patients with bilateral CSF leaks confirmed by imaging and biochemical testing (e.g., beta-2 transferrin).

3- Patients with bilateral CSF leak and sever septal spur. 4- Patients with bilateral CSF leak and history of submucosal resection of nasal septum.

5- Patients with bilateral CSF leak and large septal perforation. 6- Patients with bilateral CSF Leak and septal granuloma.

Exclusion Criteria: 1- Patients with contraindications to endoscopic surgery. 2- Active sinus or nasal infections. 3- Previous nasal or skull base surgery affecting the repair site.

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Where it's running

• Kafrelsheikh Faculty of Medicine
  Kafr Elsheikh, Kafrelsheikh, Egypt Recruiting

Study contacts

• Study coordinator: Amr Maher Shady, resident
• Email: amrshady00@gmail.com
• Phone: 0473109517

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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.