Quantitative fluorescence-guided perfusion assessment of the anastomosis during gastrointestinal surgery

Conditions: 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

Registration Number: NL-OMON26683

Lead Sponsor: prof. dr. M.I. van Berge Henegouwen, prof dr. P.J. Tanis, dr. R.Hompes

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 199

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
The main secondary objective is to evaluate the relation between quantitative FA-parameters to hemodynamic parameters, including vitals and inotropic or vasopressive drug use. <br>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. <br>.