CSF Leakage
Conditions
Brief summary
Limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat cerebrospinal fluid (CSF) leak, and the results were inconclusive. The overall purpose of this study was to assess the efficacy and safety of free middle turbinate flap in reparing CSF leak during an endoscopic approach.
Detailed description
Cerebrospinal fluid (CSF) rhinorrhea results from an abnormal communication between the sinonasal cavity and the subarachnoid space. It may occur spontaneously or secondary to accidental or iatrogenic trauma. CSF leak is a potentially devastating condition that can lead to ascending meningitis, pneumocephalus, and intracranial abscess. Surgical repair is recommended for most patients with CSF leaks to prevent the potential sequelae. Multiple graft materials have been employed in the approach, including temporalis fascia, middle turbinate flap, fascia lata, fat, free cartilage or bone, vascularized nasoseptal flap and acellular skin grafts. Among these options, vascular nasoseptal flaps are the most popular materials at present. Limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat CSF rhinorrhea, and the results were inconclusive. There were a large number of cases using free middle turbinate flap for CSF rhinorrhea repair in our institution. The purpose of this study was to determine the efficacy and safety of the free middle turbinate flap for repair of CSF rhinorrhea.
Interventions
DEVICEfree middle turbinate flap
Repairing low flow leak using free middle turbinate flap
DEVICEvascularized nasoseptal flap
Repairing low flow leak using fascia lata
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing repairing of CSF leak under transsphenoidal approach * Dural defect smaller than 1cm * No extensive arachnoid dissection * No dissection into a ventricle or cistern
Exclusion criteria
* High flow CSF leak
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Cerebrospinal Fluid (CSF) Leak | 1month |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Postoperative Complications | 1 year |
Countries
China
Contacts
Primary ContactQiangping Wang, MD
Backup ContactQiangping Wang
Outcome results
None listed