The hypothesis is that the slope of the curve will predict patient outcomes
ID
Bron
Verkorte titel
Aandoening
Patients that undergo FA-guided (1) esophagectomy (2) ileal pouch-anal anastomosis (IPAA), or (3) a partial or total mesorectal excision for colorectal cancer with restoration of bowel continuity will be included
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main objective of this study is to evaluate quantitative FA-parameters before and after anastomotic reconstruction, during (1) esophagectomy (2) IPAA and (3) a partial or total mesorectal excision with restoration of bowel continuity and to relate these parameters to patient outcomes, including anastomotic leakage.
Achtergrond van het onderzoek
Fluorescence angiography (FA) using indocyanine green (ICG) is a helpful intraoperative technique to assess perfusion of the anastomosis during gastrointestinal surgery. Management according to FA seems to lower anastomotic leakage rates. However, no threshold is known for adequate perfusion. To evaluate ICG fluorescence objectively, we aim to quantify the fluorescent signal of FA.
The main objective of this study is to evaluate quantitative FA-parameters before and after anastomotic reconstruction and relate the parameters to patient outcomes in terms of anastomotic leakage.
Doel van het onderzoek
The hypothesis is that the slope of the curve will predict patient outcomes
Onderzoeksopzet
One year
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible for inclusion in this study, a patient must meet all of the following criteria:
- Age of 18 years and older;
- Informed consent
- Scheduled for one of the following options:
1. an esophagectomy for esophageal cancer with gastric conduit reconstruction;
2. proctocolectomy or completion proctectomy with IPAA for inflammatory bowel disease (IBD) or inherited colorectal cancer disorders;
3. a partial or total mesorectal excision for colorectal cancer with restoration of bowel continuity;
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded:
- Allergy to ICG, iodide or sodium iodide;
- Hyperthyroidism or benign thyroid tumour;
- Thyroid examination using radioactive iodide <1 week;
- Breast-feeding or pregnancy;
- No informed consent.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8653 |
| Ander register | METC AMC : W20_229 |