NCT04784169

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

January 8, 2021

Last Update Submit

March 3, 2021

Conditions

CSF Leakage

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Cerebrospinal Fluid (CSF) Leak

    1month

Secondary Outcomes (1)

  • Number of Participants With Postoperative Complications

    1 year

Study Arms (2)

free middle turbinate flap group

EXPERIMENTAL

A free middle turbinate flap is used to repair the leakage

Device: free middle turbinate flap

vascularized nasoseptal flap

ACTIVE COMPARATOR

A vascularized nasoseptal flap is used to repair the leakage

Device: vascularized nasoseptal flap

Interventions

free middle turbinate flapDEVICE

Repairing low flow leak using free middle turbinate flap

free middle turbinate flap group
vascularized nasoseptal flapDEVICE

Repairing low flow leak using fascia lata

vascularized nasoseptal flap

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • High flow CSF leak

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GAO HUI

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Rhinorrhea

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid LeakNeurologic ManifestationsNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemSigns and SymptomsPathological Conditions, Signs and SymptomsRhinorrheaSigns and Symptoms, RespiratoryWounds and Injuries

Study Officials

  • GAO HUI

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

    STUDY CHAIR

Central Study Contacts

Qiangping Wang, MD

CONTACT

+8613476850638kouxiangtang7595@163.com

Qiangping Wang

CONTACT

kouxiangtang7595@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 8, 2021

First Posted

March 5, 2021

Study Start

April 1, 2021

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

CN(1)