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

CSF Leakage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04784169
• Other study ID #: 20210086
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: January 2023

Study information

• Verified date: March 2021
• Source: Wuhan Union Hospital, China
• Contact: Qiangping Wang, MD
• Phone: +8613476850638
• Email: kouxiangtang7595[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak
• CSF Leakage

Intervention

Device:
• free middle turbinate flap
Repairing low flow leak using free middle turbinate flap
• vascularized nasoseptal flap
Repairing low flow leak using fascia lata

Locations

Country	Name	City	State
China	GAO HUI	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Cerebrospinal Fluid (CSF) Leak		1month
Secondary	Number of Participants With Postoperative Complications		1 year