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

NCT ID: NCT04784169

Last Updated: 2021-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2023-01-31

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.

Conditions

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CSF Leakage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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free middle turbinate flap group

A free middle turbinate flap is used to repair the leakage

Group Type EXPERIMENTAL

free middle turbinate flap

Intervention Type DEVICE

Repairing low flow leak using free middle turbinate flap

vascularized nasoseptal flap

A vascularized nasoseptal flap is used to repair the leakage

Group Type ACTIVE_COMPARATOR

vascularized nasoseptal flap

Intervention Type DEVICE

Repairing low flow leak using fascia lata

Interventions

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free middle turbinate flap

Repairing low flow leak using free middle turbinate flap

Intervention Type DEVICE

vascularized nasoseptal flap

Repairing low flow leak using fascia lata

Intervention Type DEVICE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Qiangping Wang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GAO HUI

Role: STUDY_CHAIR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

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GAO HUI

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Qiangping Wang, MD

Role: CONTACT

+8613476850638

Qiangping Wang

Role: CONTACT

Facility Contacts

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GAO HUI

Role: primary

+8613476850638

Other Identifiers

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20210086

Identifier Type: -

Identifier Source: org_study_id

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