CSF LeakageNCT04784169
Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
A study testing free middle turbinate flap and vascularized nasoseptal flap in people with CSF Leakage, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CSF Leakage
- What is being tested?
- free middle turbinate flap and vascularized nasoseptal flap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- High flow CSF leak
Trial locations and contacts
1 site in 1 country.
Qiangping Wang contact
About this study
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.
Read the 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.
- Conditions
- CSF Leakage
- Being tested
- free middle turbinate flap, vascularized nasoseptal flap
- Medical subject headings
- Cerebrospinal Fluid Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free middle turbinate flapDevice
Repairing low flow leak using free middle turbinate flap
vascularized nasoseptal flapDevice
Repairing low flow leak using fascia lata
| Study group | Role | What they receive |
|---|---|---|
| free middle turbinate flap group | Experimental | A free middle turbinate flap is used to repair the leakage Receives: Device: free middle turbinate flap |
| vascularized nasoseptal flap | Active comparator | A vascularized nasoseptal flap is used to repair the leakage Receives: Device: vascularized nasoseptal flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Cerebrospinal Fluid (CSF) Leak
Measured: 1month
Secondary outcomes (1)
Number of Participants With Postoperative Complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CSF LeakageStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiangping Wang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- GAO HUI, Study chair, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784169
- Sponsor's protocol ID
- 20210086
- Status last verified
- Mar 2021
- First submitted
- 8 Jan 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
- ClinicalTrials.gov ID
- NCT04784169
- Acronym / sponsor ID
- 20210086
- Conditions
- CSF Leakage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| free middle turbinate flap group | Experimental | Device: free middle turbinate flapA free middle turbinate flap is used to repair the leakage |
| vascularized nasoseptal flap | Active comparator | Device: vascularized nasoseptal flapA vascularized nasoseptal flap is used to repair the leakage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- High flow CSF leak
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| free middle turbinate flapRepairing low flow leak using free middle turbinate flap | Device | free middle turbinate flap group |
| vascularized nasoseptal flapRepairing low flow leak using fascia lata | Device | vascularized nasoseptal flap |
Primary outcome
Number of Participants With Cerebrospinal Fluid (CSF) Leak
Time frame: 1month
1 secondary outcome
Number of Participants With Postoperative Complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiangping Wang contact
GAO HUI study chair
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing free middle turbinate flap and vascularized nasoseptal flap in people with CSF Leakage, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiangping Wang, MD (+8613476850638, kouxiangtang7595@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Cerebrospinal Fluid (CSF) Leak (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.