We hypothesize that NIRF angiography has added value for peri-operative evulation of flap design and free flap perfusion and subsequently we hypothesize that hyperspectral imaging and thermal imaging have added value for monitoring free flap…
ID
Bron
Verkorte titel
Aandoening
Defects caused by oncological resection or trauma.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study parameter will be the ICG-derived fluorescence intensities during pre-, per- and post-operatively NIRF angiography. In addition, the other main study parameters are the HSI oxygenation values and thermal imaging skin temperature values observed during postoperative evaluation of the flap.
Achtergrond van het onderzoek
Adequate flap perfusion is crucial for reconstructive surgery success rates in order to restore function and normal appearance. Peri-operative feedback on flap design and postoperative monitoring of flap viability is known to be challenging, with limited accurate diagnostic imaging modalities available. Near-infrared fluorescence (NIRF) angiography with indocyanine green as dye that can visualize the cutaneous blood flow of the flap. In addition, post-operative flap viability can be determined with tissue perfusion measurement with techniques such as hyperspectral imaging and thermal imaging. In this study we want to determine the added value of NIRF angiography for peri-operative evaluation of flap design and free flap perfusion and subsequently the added value of hyperspectral imaging and thermal imaging for monitoring of free flap perfusion after reconstructive surgery.
Doel van het onderzoek
We hypothesize that NIRF angiography has added value for peri-operative evulation of flap design and free flap perfusion and subsequently we hypothesize that hyperspectral imaging and thermal imaging have added value for monitoring free flap perfusion after reconstructive surgery
Onderzoeksopzet
Pre operatively , several times intraoperatively and twice daily post operatively untill discharge and once during post-op follow-up appointment.
Onderzoeksproduct en/of interventie
There will be no interventions in this study, it is an observational study
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients ≥ 18 years old that are fit for surgery and scheduled to undergo free flap surgery for reconstruction of a defect caused by oncological resection or trauma will be included.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Pregnancy or lactation; Participation in another fluorescence imaging study investigating ICG or a targeted optical imaging agent in the near-infrared fluorescence imaging wavelength (>650 nm) within one month prior to enrollment; A known severe hepatic or renal insufficiency; A history of hyperthyroidism; An autonomous thyroid adenoma; A history of allergic reactions to ICG or Iodine
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8380 |
| Ander register | METC UMCG : METC2019457 |