Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial) (VISION)
Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The VISION Trial is a prospective, multicentre, open-label, parallel-group randomised controlled trial comparing intraoperative indocyanine green (ICG) fluorescence angiography with standard clinical assessment for flap perfusion in head and neck free flap reconstruction.
Free flap reconstruction is an essential component of complex head and neck reconstruction, but flap survival depends on adequate microvascular perfusion. Conventional intraoperative assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination, provide indirect assessment of perfusion and may be unreliable in some situations.
ICG fluorescence angiography enables real-time visualisation of arterial inflow and venous outflow using near-infrared fluorescence imaging. Retrospective studies have suggested that ICG angiography may reduce rates of partial flap loss and flap-related re-exploration, but high-quality prospective randomised evidence remains limited.
A total of 244 adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects at participating Swedish centres will be included. Participants will be randomised to either standard clinical assessment alone or standard clinical assessment supplemented with intraoperative ICG fluorescence angiography.
In the intervention group, ICG angiography will be performed intraoperatively using near-infrared fluorescence imaging systems after administration of intravenous indocyanine green (Verdye®). Quantitative perfusion analysis will also be performed using SPY-Q software.
The primary endpoint is partial flap loss requiring intervention within 30 days after surgery. Secondary endpoints include total flap loss, flap-related re-exploration under general anaesthesia, flap salvage, postoperative complications graded according to Clavien-Dindo classification, and the association between intraoperative SPY-Q perfusion values and flap outcomes.
No additional trial-specific postoperative visits are required. Outcomes will be assessed through structured chart review at 30 and 90 days postoperatively.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 4
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Pooya Rajabaleyan, MD, PhD
- Numer telefonu: +4640331000
- E-mail: Pooya.r@hotmail.com
Lokalizacje studiów
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Malmö, Szwecja
- Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.
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Kontakt:
- Pooya Rajabaleyan, MD, PhD
- Numer telefonu: +4640331000
- E-mail: Pooya.r@hotmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Age ≥18 years at the time of inclusion
- Scheduled to undergo microvascular free flap reconstruction as part of oncologic, trauma, or benign surgery in the head and neck area
- Ability to understand study information and provide written informed consent
Exclusion Criteria:
- Known allergy to indocyanine green or iodine
- Severe hepatic or renal impairment
- Confirmed or suspected pregnancy
- Breastfeeding
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Standard clinical assessment
Participants undergo intraoperative assessment of free flap perfusion using standard clinical assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated.
Surgical revision is performed according to standard clinical practice if inadequate perfusion is suspected.
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Standard intraoperative clinical assessment of free flap perfusion including evaluation of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated during head and neck free flap reconstruction.
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Eksperymentalny: Indocyanine Green Fluorescence Angiography
Participants undergo intraoperative assessment of free flap perfusion using indocyanine green (ICG) fluorescence angiography in addition to standard clinical assessment.
ICG is administered intravenously and perfusion is evaluated using near-infrared fluorescence imaging and SPY-Q quantitative perfusion analysis during head and neck free flap reconstruction.
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Standard intraoperative clinical assessment of free flap perfusion including evaluation of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated during head and neck free flap reconstruction.
Indocyanine green (ICG) is administered intravenously during surgery for intraoperative fluorescence angiography assessment of free flap perfusion in head and neck reconstruction.
A 25 mg vial of ICG (Verdye®) is reconstituted with sterile water, and approximately 7.5 mg is administered intravenously followed by saline flush.
Perfusion is assessed using near-infrared fluorescence imaging systems and SPY-Q quantitative perfusion analysis.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Partial flap loss requiring intervention
Ramy czasowe: From index surgery to 30 days postoperatively
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Partial flap loss is defined as clinically evident flap necrosis requiring active therapeutic intervention, including operative debridement/revision in the operating room or bedside debridement/trimming performed by a surgeon beyond routine wound care.
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From index surgery to 30 days postoperatively
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Total flap loss
Ramy czasowe: From index surgery to 30 days postoperatively
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Complete flap failure requiring flap removal, replacement, or abandonment with documentation of flap non-viability.
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From index surgery to 30 days postoperatively
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Flap-related re-exploration under general anaesthesia
Ramy czasowe: From index surgery to 30 days postoperatively
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Return to the operating room under general anaesthesia due to suspected or confirmed flap vascular compromise or flap viability concern, excluding planned second-look procedures without concern.
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From index surgery to 30 days postoperatively
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Flap salvage
Ramy czasowe: From index surgery to 30 days postoperatively
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Successful retention of the index flap following flap-related re-exploration for vascular compromise.
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From index surgery to 30 days postoperatively
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Postoperative complications
Ramy czasowe: From index surgery to 90 days postoperatively
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Incidence of postoperative complications occurring 90 days after index operation.
Predefined surgical complications will be captured systematically and include surgical takeback, partial flap loss, total flap loss, infection, hematoma or bleeding requiring intervention, fistula formation, wound dehiscence, seroma, abnormal wound healing, and other surgical complications.
The severity of complications will be classified according to the Clavien-Dindo Classification of Surgical Complications (Grade I-V, where Grade I represents the least severe complication and Grade V represents death).
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From index surgery to 90 days postoperatively
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Correlation between intraoperative SPY-Q Relative Perfusion Value (%) and partial flap loss
Ramy czasowe: From index surgery to 30 days postoperatively
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Correlation between intraoperative tissue perfusion measured using SPY-Q quantitative analysis software following indocyanine green fluorescence angiography and postoperative partial flap loss within 30 days after surgery.
SPY-Q Relative Perfusion Value is reported as a percentage ranging from 0% to 100%, where higher values indicate greater tissue perfusion.
Partial flap loss is assessed clinically and recorded as a binary outcome (present or absent).
The outcome measure is the correlation coefficient between SPY-Q Relative Perfusion Value and partial flap loss.
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From index surgery to 30 days postoperatively
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Pooya Rajabaleyan, MD, PhD, Region Skåne, Skånes universitetssjukhus, Sektion Plastikkirurgi, Malmö, Sverige
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-524710-29-00 (Ctis)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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