Internal nasal splint–supported free graft versus nasoseptal flap for repairing bilateral CSF leaks
Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
NA · Kafrelsheikh University · NCT07368348
This trial will test whether using an internal nasal splint to support a free graft repairs bilateral CSF leaks better than the standard nasoseptal flap in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University (other) |
| Locations | 1 site (Kafr Elsheikh, Kafrelsheikh) |
| Trial ID | NCT07368348 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with confirmed bilateral CSF leaks, including those with septal spurs, large perforations, prior submucosal septal resection, or septal granuloma, are the intended candidates.
Not a fit: Patients with active nasal or sinus infection, contraindications to endoscopic surgery, or prior nasal/skull base operations that affect the repair site are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the splint-supported graft approach could reduce leak recurrence and the need for repeat surgery in patients with bilateral CSF leaks.
How similar studies have performed: Nasoseptal flaps are an established and successful method for endoscopic skull base repair, while internal splint-supported free grafts represent a newer approach with limited published evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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. \-
Where this trial is running
Kafr Elsheikh, Kafrelsheikh
- Kafrelsheikh Faculty of Medicine — Kafr Elsheikh, Kafrelsheikh, Egypt (RECRUITING)
Study contacts
- Study coordinator: Amr Maher Shady, resident
- Email: amrshady00@gmail.com
- Phone: 0473109517
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.
Conditions: CSF Leak, CSF, Stent