Intraoperative indocyanine green angiography for evaluation of nasoseptal flap vascularization in endoscopic skull base surgery

Phase 4

Recruiting

• Conditions: Patients who underwent endoscopic skull base surgery and required a nasoseptal flap for skull base defect reconstruction.; nasoseptal flap; indocyanine green; endoscopic skull base surgery; cerebrospinal fluid leak; skull base reconstruction; flap necrosis

• Registration Number: TCTR20240706007
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-07-04
• Study Start: 2024-07-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Patients aged 18 years or older.
2.Patients who underwent endoscopic skull base surgery via the nasal cavity

Exclusion Criteria

1.Patients who have previously undergone endonasal surgery.
2.Patients with allergies to ICG, iodine-containing substances, or seafood.
3.Pregnant or breastfeeding patients.
4.Patients with chronic renal failure (GFR less than 45 ml/min/1.73 m2) or those requiring dialysis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Classification of blood vessel characteristics supplying the nasal septum visualized after ICG injection. after injection number

Secondary Outcome Measures

Name	Time	Method
Enhancement patterns of the nasal septum vasculature after its placement for skull base defect reconstruction at the time of flap placement number,Relationship between the characteristics of blood vessels supplying the nasal septum after ICG injection and the pattern of flap enhancement post-surgery. at the time of flap placement percent,Relationship between the rate of cerebral vascular leakage and the characteristics of the blood vessels supplying the nasal septum postoperative period percent,Flap necrosis postoperative period number,Relationship between the rate of flap necrosis and the characteristics of the blood vessels supplying the nasal septum postoperative period percent,Relationship between the enhancement pattern of the flap on CT scan and the characteristics of the blood vessels supplying the nasal septum postoperative period percent