ERAS protocol and Indocyanine Green Fluorescence Angiography (ICG FA) represent the new surgical revolution minimizing complications and shortening recovery time in colorectal surgery. As of today no studies have been published in the literature evaluating the impact of the ICG FA in the ERAS protocol for the patients suitable for colorectal surgery. The aim of our study was to assess whether the systematic evaluation of intestinal perfusion by ICG FA could improve patients outcomes when managed with ERAS perioperative protocol thus reducing surgical complication rate. METHODS: This is a retrospective case-control study. From March 2014 to April 2017, 182 patients underwent laparoscopic colorectal surgery for benign and malignant diseases. All the patients were enrolled in ERAS protocol. Two groups were created: Group A comprehended 107 patients managed within the ERAS pathway only and Group B comprehended 75 patients managed as well as with ERAS pathway plus the intraoperative assessment of intestinal perfusion with ICG FA. All procedures were performed by two boarded-certified laparoscopic colorectal surgeons. RESULTS: Six (5,6%) clinically relevant Anastomotic Leakages (AL) occurred in Group A while there was none in Group B, demonstrating that ICG FA integrated in the ERAS protocol can lead to a statistically significant reduction of the AL. Mean operative time between the two groups was not statistically significant. In 5 cases (6,6%) the demarcation line set by the fluorescence made the surgeon change the resection line previously marked. The prevalence of all other complications did not differ statistically between the two groups. CONCLUSION: Our study confirms that combination between ICG and ERAS protocol is feasible and safe and reduces the anastomotic leakage, possibly leading to consider ICG FA as a new ERAS item.
ERAS Protocol and ICG FA represent the two surgical revolutions of this last decade. Despite the improvements of surgical technics, colorectal surgery still suffers of a high level of complication rate, which represents a continuous challenge for surgeons. At the moment, no studies have been published in the literature evaluating whether ICG FA could impact in the ERAS Protocol. In fact, adequate perfusion remains one of the principal factors affecting complete anastomotic healing and consequently AL occurrence. Moreover, anatomic variations and aberrations are very common in colonic vascular anatomy and high ligation of Inferior Mesenteric Artery is a well-recognized practice for the best oncological results, but it has been identified as a risk factor for anastomotic leakage. On the other hand, chemioradiation, aged population, vascular diseases and previous vascular surgery are thought to determine inadequate blood supply to the anastomosis.12,17,38,39
A Systematic review of clinical trials by Degett et al. on ¿Indocyanine Green fluorescence angiography for intraoperative assessment of gastrointestinal anastomotic perfusion¿31 reported that in colorectal cancer the leakage rate was 3,83% in all patients undergoing ICG-FA assessment, regardless of intraoperative changes in surgical procedure. Intraoperative ICG-FA assessment was associated with a significantly lower leakage rate compared with controls without ICG-FA assessment whereof 7.58% had an anastomotic leakage.
Boni et al.32 performed intraoperative FA with ICG in 42 patients undergoing laparoscopic Low Anterior Resection with TME for rectal cancer and reported a drop in AL rate from 5% to 0%.
Jafari et al.30 reported a series of 147 patients in which FA changed surgical plan in 11 pts. (8%). The overall anastomotic Leakage rate was 1.4 %( n=2) and there were no AL in the 11 patients who had a change in surgical plan based on ICG FA.
In our study six AL occurred (5,6% - P= 0.03), all in Group A and none in Group B, demonstrating a statistically significant reduction of the AL in this last group treated with ERAS protocol + ICG FA.
This paper underline the feasibility of the combination between the innovative clinical perioperative practice in colorectal surgery and ICG FA technology.
Benefits derived from ERAS protocol are now worldwide accepted and demonstrated33,34 and FA with Indocyanine Green is considered a promising safe and effective technique able to provide valuable information about the vascular perfusion guiding the surgeons to change the resection site and/or anastomosis, leading to a reduction in the anastomotic leakage rate.21,30-32
Despite these benefits, Indocyanine Green FA still suffers from some drawback: the ideal dose and timing of injection before assessment are still to be identified and the measurement of the signal depends on subjective evaluation of the surgeon.
We propose with this paper a valid method pf timing and dosage injection of Indocyanine Green, before colonic resection and after anastomosis exacution.