Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
Primary Purpose
CSF Leakage
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
free middle turbinate flap
vascularized nasoseptal flap
Sponsored by
About this trial
This is an interventional treatment trial for CSF Leakage
Eligibility Criteria
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
Sites / Locations
- GAO HUI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
free middle turbinate flap group
vascularized nasoseptal flap
Arm Description
A free middle turbinate flap is used to repair the leakage
A vascularized nasoseptal flap is used to repair the leakage
Outcomes
Primary Outcome Measures
Number of Participants With Cerebrospinal Fluid (CSF) Leak
Secondary Outcome Measures
Number of Participants With Postoperative Complications
Full Information
NCT ID
NCT04784169
First Posted
January 8, 2021
Last Updated
March 3, 2021
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT04784169
Brief Title
Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
Official Title
Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CSF Leakage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
free middle turbinate flap group
Arm Type
Experimental
Arm Description
A free middle turbinate flap is used to repair the leakage
Arm Title
vascularized nasoseptal flap
Arm Type
Active Comparator
Arm Description
A vascularized nasoseptal flap is used to repair the leakage
Intervention Type
Device
Intervention Name(s)
free middle turbinate flap
Intervention Description
Repairing low flow leak using free middle turbinate flap
Intervention Type
Device
Intervention Name(s)
vascularized nasoseptal flap
Intervention Description
Repairing low flow leak using fascia lata
Primary Outcome Measure Information:
Title
Number of Participants With Cerebrospinal Fluid (CSF) Leak
Time Frame
1month
Secondary Outcome Measure Information:
Title
Number of Participants With Postoperative Complications
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiangping Wang, MD
Phone
+8613476850638
Email
kouxiangtang7595@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiangping Wang
Email
kouxiangtang7595@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GAO HUI
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Chair
Facility Information:
Facility Name
GAO HUI
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GAO HUI
Phone
+8613476850638
12. IPD Sharing Statement
Learn more about this trial
Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
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