Comparing intraoperative indocyanine green fluorescence imaging with standard clinical assessment for flap perfusion in head and neck reconstruction: A randomised controlled Trial (VISION Trial)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524710-29-00

Enrollment

244

Registered

2026-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer

Brief summary

The primary endpoint is incidence of partial flap loss requiring surgical intervention within 1 month.

Detailed description

The secondary endpoints of this trial are total flap loss, flap related re-exploration rate in general anaesthesia and flap salvage rate within one month, and postoperative complications (graded according to the Clavien-Dindo classification) within three months.

Interventions

DRUGVerdye 5 mg/ml pulver till injektionsvätska

DRUGlösning

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is incidence of partial flap loss requiring surgical intervention within 1 month.	—

Secondary

Measure	Time frame
The secondary endpoints of this trial are total flap loss, flap related re-exploration rate in general anaesthesia and flap salvage rate within one month, and postoperative complications (graded according to the Clavien-Dindo classification) within three months.	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 23, 2026