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

Not Applicable

• Conditions: CSF Leakage
• Interventions: Device: vascularized nasoseptal flap; Device: free middle turbinate flap

• Registration Number: NCT04784169
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Study First Submitted: 2021-01-08
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-03
• Last Update Submitted: 2021-03-03
• Study First Posted: 2021-03-05
• Last Update Posted: 2021-03-05
• Study Start: 2021-04
• Primary Completion: 2022-12
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vascularized nasoseptal flap	vascularized nasoseptal flap	A vascularized nasoseptal flap is used to repair the leakage
free middle turbinate flap group	free middle turbinate flap	A free middle turbinate flap is used to repair the leakage

Primary Outcome Measures

Name	Time	Method
Number of Participants With Cerebrospinal Fluid (CSF) Leak	1month

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Complications	1 year

Trial Locations

Locations (1)

GAO HUI; 🇨🇳 Wuhan, Hubei, China