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ID
Source
Brief title
Health condition
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
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
The main secondary objective is to evaluate the relation between quantitative FA-parameters to hemodynamic parameters, including vitals and inotropic or vasopressive drug use.
Other secondary objectives include measuring differences in quantitative FA-parameters with different distances to the anastomosis, and the comparison of quantitative FA-parameters between arterial and venous ischemia.
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Background summary
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.
Study objective
The hypothesis is that the slope of the curve will predict patient outcomes
Study design
One year
Inclusion criteria
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;
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8653 |
| Other | METC AMC : W20_229 |