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

Huazhong University of Science and Technology

Status: Unknown

Conditions: CSF Leakage

Treatments: Device: free middle turbinate flap; Device: vascularized nasoseptal flap

Study type: Interventional

Funder types: Other

Identifiers

NCT04784169

20210086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

free middle turbinate flap group

Experimental group

Description:

A free middle turbinate flap is used to repair the leakage

Treatment:

Device: free middle turbinate flap

vascularized nasoseptal flap

Active Comparator group

Description:

A vascularized nasoseptal flap is used to repair the leakage

Treatment:

Device: vascularized nasoseptal flap