Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak

Study Overview
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Brief Summary
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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
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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.

Official Title
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Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak

Conditions
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CSF Leakage

Intervention / Treatment
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* Device: free middle turbinate flap
* Device: vascularized nasoseptal flap


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: free middle turbinate flap group<br>A free middle turbinate flap is used to repair the leakage | Device: free middle turbinate flap<br>* Repairing low flow leak using free middle turbinate flap<br>|
| Active Comparator: vascularized nasoseptal flap<br>A vascularized nasoseptal flap is used to repair the leakage | Device: vascularized nasoseptal flap<br>* Repairing low flow leak using fascia lata<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Cerebrospinal Fluid (CSF) Leak |  | 1month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postoperative Complications |  | 1 year |