Incidence of anastomotic leakage using powered circular staplers versus manual circular staplers for left colorectal anastomosis: a cost-effectiveness analysis.

BACKGROUND: Colorectal anastomotic leakage causes severe consequences for patients and healthcare system as it will lead to increased consumption of hospital resources and costs. Technological improvements in anastomotic devices could reduce the incidence of leakage and its economic impact. The aim of the present study was to assess if the use of a new powered circular stapler is cost-effective. METHOD: This observational study included patients undergoing left-sided circular stapled colorectal anastomosis between January 2018 and December 2021. Propensity score matching was carried out to create two comparable groups depending on whether the anastomosis was performed using a manual or powered circular device. The rate of anastomotic leakage, its severity, the consumption of hospital resources, and its cost were the main outcome measures. A cost-effectiveness analysis comparing the powered circular stapler versus manual circular staplers was performed. RESULTS: A total of 330 patients were included in the study, 165 in each group. Anastomotic leakage rates were significantly different (p = 0.012): 22 patients (13.3%) in the manual group versus 8 patients (4.8%) in the powered group. The effectiveness of the powered stapler and manual stapler was 98.27% and 93.69%, respectively. The average cost per patient in the powered group was €6238.38, compared with €9700.12 in the manual group. The incremental cost-effectiveness ratio was - €74,915.28 per patient without anastomotic complications. CONCLUSION: The incremental cost of powered circular stapler compared with manual devices was offset by the savings from lowered incidence and cost of management of anastomotic leaks.

Quantitative assessment of gastric ischemic preconditioning on conduit perfusion in esophagectomy: propensity score weighting study.

BACKGROUND: Gastric ischemic preconditioning prior to esophagectomy has been studied as a method to improve gastric conduit perfusion and reduce anastomotic complications, without conclusive results. The aim of this study is to evaluate the feasibility and safety of gastric ischemic preconditioning in terms of post-operative outcomes and quantitative gastric conduit perfusion. METHODS: Patients who underwent an esophagectomy with gastric conduit reconstruction between January 2015 and October 2022 at a single high-volume academic center were reviewed. Patient characteristics, surgical approach, post-operative outcomes, and indocyanine green fluorescence angiography data (ingress index for arterial inflow and ingress time for venous outflow, and the distance from the last gastroepiploic branch to the perfusion assessment point) were analyzed. Two propensity score weighting methods were used to investigate whether gastric ischemic preconditioning reduces anastomotic leaks. Multiple linear regression analysis was used to evaluate the conduit perfusion quantitatively. RESULTS: There were 594 esophagectomies with gastric conduit performed, with 41 having a gastric ischemic preconditioning. Among 544 with cervical anastomoses, leaks were seen in 2/30 (6.7%) in the ischemic preconditioning group and 114/514 (22.2%) in the control group (p = 0.041). Gastric ischemic preconditioning significantly reduced anastomotic leaks on both weighting methods (p = 0.037 and 0.047, respectively). Ingress index and time of the gastric conduit with ischemic preconditioning were significantly better than those without preconditioning (p = 0.013 and 0.025, respectively) after removing the effect of the distance from the last gastroepiploic branch to the perfusion assessment point. CONCLUSION: Gastric ischemic preconditioning results in a statistically significant improvement in conduit perfusion and reduction in post-operative anastomotic leaks.

Quantification of indocyanine green near-infrared fluorescence bowel perfusion assessment in colorectal surgery.

BACKGROUND: Indocyanine green near-infrared fluorescence bowel perfusion assessment has shown its potential benefit in preventing anastomotic leakage. However, the surgeon's subjective visual interpretation of the fluorescence signal limits the validity and reproducibility of the technique. Therefore, this study aimed to identify objective quantified bowel perfusion patterns in patients undergoing colorectal surgery using a standardized imaging protocol. METHOD: A standardized fluorescence video was recorded. Postoperatively, the fluorescence videos were quantified by drawing contiguous region of interests (ROIs) on the bowel. For each ROI, a time-intensity curve was plotted from which perfusion parameters (n = 10) were derived and analyzed. Furthermore, the inter-observer agreement of the surgeon's subjective interpretation of the fluorescence signal was assessed. RESULTS: Twenty patients who underwent colorectal surgery were included in the study. Based on the quantified time-intensity curves, three different perfusion patterns were identified. Similar for both the ileum and colon, perfusion pattern 1 had a steep inflow that reached its peak fluorescence intensity rapidly, followed by a steep outflow. Perfusion pattern 2 had a relatively flat outflow slope immediately followed by its plateau phase. Perfusion pattern 3 only reached its peak fluorescence intensity after 3 min with a slow inflow gradient preceding it. The inter-observer agreement was poor-moderate (Intraclass Correlation Coefficient (ICC): 0.378, 95% CI 0.210-0.579). CONCLUSION: This study showed that quantification of bowel perfusion is a feasible method to differentiate between different perfusion patterns. In addition, the poor-moderate inter-observer agreement of the subjective interpretation of the fluorescence signal between surgeons emphasizes the need for objective quantification.

Perfusion assessment by fluorescence time curves in esophagectomy with gastric conduit reconstruction: a prospective clinical study.

BACKGROUND: Intraoperative perfusion assessment with indocyanine green fluorescence angiography (ICG-FA) may reduce postoperative anastomotic leakage rates after esophagectomy with gastric conduit reconstruction. This study evaluated quantitative parameters derived from fluorescence time curves to determine a threshold for adequate perfusion and predict postoperative anastomotic complications. METHODS: This prospective cohort study included consecutive patients who underwent FA-guided esophagectomy with gastric conduit reconstruction between August 2020 and February 2022. After intravenous bolus injection of 0.05-mg/kg ICG, fluorescence intensity was registered over time by PINPOINT camera (Stryker, USA). Fluorescent angiograms were quantitatively analyzed at a region of interest of 1 cm diameter at the anastomotic site on the conduit using tailor-made software. Extracted fluorescence parameters were both inflow (T0, Tmax, Fmax, slope, Time-to-peak) as outflow parameters (T90% and T80%). Anastomotic complications including anastomotic leakage (AL) and strictures were documented. Fluorescence parameters in patients with AL were compared to those without AL. RESULTS: One hundred and three patients (81 male, 65.7 ± 9.9 years) were included, the majority of whom (88%) underwent an Ivor Lewis procedure. AL occurred in 19% of patients (n = 20/103). Both time to peak as Tmax were significantly longer for the AL group in comparison to the non-AL group (39 s vs. 26 s, p = 0.04 and 65 vs. 51 s, p = 0.03, respectively). Slope was 1.0 (IQR 0.3-2.5) and 1.7 (IQR 1.0-3.0) for the AL and non-AL group (p = 0.11). Outflow was longer in the AL group, although not significantly, T90% 30 versus 15 s, respectively, p = 0.20). Univariate analysis indicated that Tmax might be predictive for AL, although not reaching significance (p = 0.10, area under the curve 0.71) and a cut-off value of 97 s was derived, with a specificity of 92%. CONCLUSION: This study demonstrated quantitative parameters and identified a fluorescent threshold which could be used for intraoperative decision-making and to identify high-risk patients for anastomotic leakage during esophagectomy with gastric conduit reconstruction. A significant predictive value remains to be determined in future studies.

Intraoperative bowel perfusion assessment methods and their effects on anastomotic leak rates: meta-analysis.

BACKGROUND: Anastomotic leak is one of the most feared complications of colorectal surgery, and probably linked to poor blood supply to the anastomotic site. Several technologies have been described for intraoperative assessment of bowel perfusion. This systematic review and meta-analysis aimed to evaluate the most frequently used bowel perfusion assessment modalities in elective colorectal procedures, and to assess their associated risk of anastomotic leak. Technologies included indocyanine green fluorescence angiography, diffuse reflectance spectroscopy, laser speckle contrast imaging, and hyperspectral imaging. METHODS: The review was preregistered with PROSPERO (CRD42021297299). A comprehensive literature search was performed using Embase, MEDLINE, Cochrane Library, Scopus, and Web of Science. The final search was undertaken on 29 July 2022. Data were extracted by two reviewers and the MINORS criteria were applied to assess the risk of bias. RESULTS: Some 66 eligible studies involving 11 560 participants were included. Indocyanine green fluorescence angiography was most used with 10 789 participants, followed by diffuse reflectance spectroscopy with 321, hyperspectral imaging with 265, and laser speckle contrast imaging with 185. In the meta-analysis, the total pooled effect of an intervention on anastomotic leak was 0.05 (95 per cent c.i. 0.04 to 0.07) in comparison with 0.10 (0.08 to 0.12) without. Use of indocyanine green fluorescence angiography, hyperspectral imaging, or laser speckle contrast imaging was associated with a significant reduction in anastomotic leak. CONCLUSION: Bowel perfusion assessment reduced the incidence of anastomotic leak, with intraoperative indocyanine green fluorescence angiography, hyperspectral imaging, and laser speckle contrast imaging all demonstrating comparable results.

Blood Perfusion Assessment by Indocyanine Green Fluorescence Imaging for Minimally Invasive Rectal Cancer Surgery (EssentiAL trial): A Randomized Clinical Trial.

OBJECTIVE: The aim of the present randomized controlled trial was to evaluate the superiority of indocyanine green fluorescence imaging (ICG-FI) in reducing the rate of anastomotic leakage in minimally invasive rectal cancer surgery. BACKGROUND: The role of ICG-FI in anastomotic leakage in minimally invasive rectal cancer surgery is controversial according to the published literature. METHODS: This randomized, open-label, phase 3, trial was performed at 41 hospitals in Japan. Patients with clinically stage 0-III rectal carcinoma less than 12 cm from the anal verge, scheduled for minimally invasive sphincter-preserving surgery were preoperatively randomly assigned to receive a blood flow evaluation by ICG-FI (ICG+ group) or no blood flow evaluation by ICG-FI (ICG- group). The primary endpoint was the anastomotic leakage rate (grade A+B+C, expected reduction rate of 6%) analyzed in the modified intention-to-treat population. RESULTS: Between December 2018 and February 2021, a total of 850 patients were enrolled and randomized. After the exclusion of 11 patients, 839 were subject to the modified intention-to-treat population (422 in the ICG+ group and 417 in the ICG- group). The rate of anastomotic leakage (grade A+B+C) was significantly lower in the ICG+ group (7.6%) than in the ICG- group (11.8%) (relative risk, 0.645; 95% confidence interval 0.422-0.987; P =0.041). The rate of anastomotic leakage (grade B+C) was 4.7% in the ICG+ group and 8.2% in the ICG- group ( P =0.044), and the respective reoperation rates were 0.5% and 2.4% ( P =0.021). CONCLUSIONS: Although the actual reduction rate of anastomotic leakage in the ICG+ group was lower than the expected reduction rate and ICG-FI was not superior to white light, ICG-FI significantly reduced the anastomotic leakage rate by 4.2%.

Anastomotic perfusion assessment with indocyanine green in robot-assisted low-anterior resection, a multicenter study of interobserver variation.

BACKGROUND: Securing sufficient blood perfusion to the anastomotic area after low-anterior resection is a crucial factor in preventing anastomotic leakage (AL). Intra-operative indocyanine green fluorescent imaging (ICG-FI) has been suggested as a tool to assess perfusion. However, knowledge of inter-observer variation among surgeons in the interpretation of ICG-FI is sparse. Our primary objective was to evaluate inter-observer variation among surgeons in the interpretation of bowel blood-perfusion assessed visually by ICG-FI. Our secondary objective was to compare the results both from the visual assessment of ICG and from computer-based quantitative analyses of ICG-FI between patients with and without the development of AL. METHOD: A multicenter study, including patients undergoing robot-assisted low anterior resection with stapled anastomosis. ICG-FI was evaluated visually by the surgeon intra-operatively. Postoperatively, recorded videos were anonymized and exchanged between centers for inter-observer evaluation. Time to visibility (TTV), time to maximum visibility (TMV), and time to wash-out (TWO) were visually assessed. In addition, the ICG-FI video-recordings were analyzed using validated pixel analysis software to quantify blood perfusion. RESULTS: Fifty-five patients were included, and five developed clinical AL. Bland-Altman plots (BA plots) demonstrated wide inter-observer variation for visually assessed fluorescence on all parameters (TTV, TMV, and TWO). Comparing leak-group with no-leak group, we found no significant differences for TTV: Hazard Ratio; HR = 0.82 (CI 0.32; 2.08), TMV: HR = 0.62 (CI 0.24; 1.59), or TWO: HR = 1.11 (CI 0.40; 3.11). In the quantitative pixel analysis, a lower slope of the fluorescence time-curve was found in patients with a subsequent leak: median 0.08 (0.07;0.10) compared with non-leak patients: median 0.13 (0.10;0.17) (p = 0.04). CONCLUSION: The surgeon's visual assessment of the ICG-FI demonstrated wide inter-observer variation, there were no differences between patients with and without AL. However, quantitative pixel analysis showed a significant difference between groups. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04766060.

Intraluminal Anastomotic Assessment Using Indocyanine Green Near-Infrared Imaging for Left-Sided Colonic and Rectal Resections: a Systematic Review.

BACKGROUND: Indocyanine green fluorescence angiography (ICG-FA) has been used in colorectal surgery to assess anastomotic perfusion and reduce the risks of anastomotic leaks. The main objective of this paper is to review the data on the transanal application of ICG-FA for the intraluminal assessment of colorectal anastomosis. METHODS: A literature search was conducted for articles published between 2011 and 2021 using PubMed and Cochrane databases, related to the application of ICG for the intraluminal assessment of colorectal anastomosis. Original scientific manuscripts, review articles, meta-analyses, and case reports were considered eligible. RESULTS: A total of 305 studies have been identified. After abstract screening for duplicates, 285 articles remained. Of those, 271 were not related to the topic of interest, 4 were written in a language other than English, and 4 had incomplete data. Six articles remained for the final analysis. The intraluminal assessment of colorectal anastomosis with ICG-FA is feasible, safe, and may reduce the incidence of leaks. CONCLUSION: The intraluminal assessment of anastomotic perfusion via ICG-FA may be a promising novel application of ICG technology. More data is needed to support this application further to reduce leak rates after colorectal surgery, and future randomized clinical trials are awaited.

Novel Modality of Endoluminal Anastomotic Integrity Assessment with Fluoroangiography After Left-sided Colorectal Resections.

BACKGROUND: Several methods have been described for the intraoperative evaluation of colorectal anastomotic integrity. Technological evolution has allowed to progress from basic mechanical methods to the use of more sophisticated techniques. This study describes a novel endoluminal modality of colorectal anastomotic assessment through the use of a Disposable Rigid Scope Introducer (DRSI) also allowing for intraoperative endoluminal perfusion evaluation by indocyanine green (ICG) fluoroangiography in patients undergoing left-sided colorectal resection. METHODS: The DRSI consists of an endoluminal introducer device made up of an insertion tube and port connected to an insufflation bulb to manually insufflate the sigmoid and rectum and is compatible with any laparoscopic camera, also allowing for ICG fluoroangiography for perfusion purposes. RESULTS: The DRSI was successfully used to assess anastomotic integrity after left-sided colorectal resections performed in 16 consecutive patients. The DRSI allowed to visualize by fluoroangiography the quality of tissue perfusion at the anastomotic site in all cases, contributing to the decision of avoiding loop ileostomies in low rectal resections. In 2 cases, the DRSI showed the presence of significant anastomotic bleeding which was successfully controlled by laparoscopic suture placement. No adverse event resulted from the use of this device. CONCLUSIONS: The DRSI combines direct endoluminal visualization of the anastomosis together with real-time evaluation of its blood flow. This device holds great potential for prompt intraoperative detection of anastomotic alterations, possibly reducing the risk of postoperative anastomotic bleeding or leaks related to mechanical construction/perfusion issues. Potential advantages of this device warrant larger cohort studies and prospective randomized trials.

Cost-effectiveness comparison of delayed versus immediate coloanal anastomosis following ultralow anterior resection for rectal cancer.

BACKGROUND: Following ultralow anterior resection for distal rectal cancers, a coloanal anastomosis is usually created along with a defunctioning ileostomy (DI). Recent evidence suggests that abdominoperineal pull-through with delayed coloanal anastomosis (DCAA) is a viable alternative to immediate coloanal anastomosis (ICAA), minimizing the risk of anastomotic leakage and avoiding the need for stoma creation with the risk of stoma-associated morbidity. However, DCAA requires a longer initial hospitalization. We aimed to perform a cost-effectiveness analysis to compare DCAA versus ICAA for elective rectal cancer surgery. METHODS: A decision tree model was used to compare the cost-effectiveness of the two strategies. Cost data were obtained from the 2019 to 2020 United Kingdom National Health Service reference costs. Model probabilities were derived from published studies. Univariate and probabilistic sensitivity analyses were used to evaluate the robustness of the results. RESULTS: DCAA was the overall cheaper strategy at £13 541 compared with £14 856 for ICAA in the base case analysis. This was explained by the decreased overall costs of hospitalization/surgery, reduction in costs associated with anastomotic or stoma-related complications, specifically dehydration-induced hospital readmissions and avoidance of stoma maintenance costs. Sensitivity analysis demonstrated that DCAA remained consistently more inexpensive except when the duration of total parenteral nutrition exceeded 14 days. CONCLUSION: Despite a longer index hospitalization with higher initial costs, this economic analysis demonstrates that DCAA without stoma is overall more cost-effective compared with ICAA with DI following ultralow anterior resection. Cost savings should be considered an additional benefit when selecting the DCAA approach for rectal cancer surgery.

[Intraoperative fluorescence-guided perfusion assessment using indocyanine green-Increased safety in gastrointestinal anastomoses?] / Intraoperative fluoreszenzgestützte Perfusionsmessung mit Indocyaningrün ­ erhöhte Sicherheit bei gastrointestinalen Anastomosen?

Insufficiency of gastrointestinal anastomoses represents a relevant risk of morbidity and mortality for affected patients. The perfusion quality of the ends of the intestine is the decisive parameter for ensuring sufficient healing of an anastomosis. Intraoperative fluorescence-guided perfusion assessment with indocyanine green is increasingly being used in modern visceral surgery to evaluate tissue perfusion prior to the fashioning of gastrointestinal anastomoses. This technique provides the possibility to distinguish between adequately and inadequately perfused tissue in order to place the anastomosis in the region with the best possible perfusion. Thus, surgeons have a measuring instrument that enables an objective assessment of the perfusion quality of the tissue to be undertaken in addition to a purely subjective macroscopic visual assessment, in order to achieve a better functional result for the patients. Currently, however, the value of this technique has not yet been conclusively clarified. The aim of this review article is to characterize the benefits of intraoperative fluorescence-guided perfusion assessment and to classify it with respect to its significance for routine clinical practice.

Risk factors and economic burden of postoperative anastomotic leakage related events in patients who underwent surgeries for colorectal cancer.

BACKGROUND: Nationwide research about the clinical and economic burden caused by anastomotic leakage (AL) has not been published yet in Korea. This study assessed the AL rate and quantified the economic burden using the nationwide database. METHODS: This real world evidence study used health claims data provided by the Korean Health Insurance Review and Assessment Service (HIRA, which showed that 156,545 patients underwent anterior resection (AR), low anterior resection (LAR), or ultra-low anterior resection (uLAR) for colorectal cancer (CRC) between January 1, 2007 and January 31, 2020. The incidence of AL was identified using a composite operational definition, a composite of imaging study, antibacterial drug use, reoperation, or image-guided percutaneous drainage. Total hospital costs and length of stay (LOS) were evaluated in patients with AL versus those without AL during index hospitalization and within 30 days after the surgery. RESULTS: Among 120,245 patients who met the eligibility criteria, 7,194 (5.98%) patients had AL within 30 days after surgery. Male gender, comorbidities (diabetes, metastatic disease, ischemic heart disease, ischemic stroke), protective ostomy, and multiple linear stapler use, blood transfusion, and urinary tract injury were associated with the higher odds of AL. Older age, rectosigmoid junction cancer, AR, LAR, and laparoscopic approach were related with the reduced odds of AL. Patients with AL incurred higher costs for index hospitalization compared to those without AL (8,991 vs. 7,153 USD; p<0.0001). Patients with AL also required longer LOS (16.78 vs. 14.22 days; p<0.0001) and readmissions (20.83 vs. 13.93 days; p<0.0001). CONCLUSION: Among patients requiring resection for CRC, the occurrence of AL was associated with significantly increased costs and LOS. Preventing AL could not only produce superior clinical outcomes, but also reduce the economic burden for patients and payers.

Selective decontamination of the digestive tract in colorectal surgery reduces anastomotic leakage and costs: a propensity score analysis.

PURPOSE: Anastomotic leakage (AL) and surgical site infection (SSI) account for most postoperative complications in colorectal surgery. The aim of this retrospective trial was to investigate whether perioperative selective decontamination of the digestive tract (SDD) reduces these complications and to provide a cost-effectiveness model for elective colorectal surgery. METHODS: All patients operated between November 2016 and March 2020 were included in our analysis. Patients in the primary cohort (PC) received SDD and those in the historical control cohort (CC) did not receive SDD. In the case of rectal/sigmoid resection, SDD was also applied via a transanally placed Foley catheter (TAFC) for 48 h postoperatively. A propensity score-matched analysis was performed to identify risk factors for AL and SSI. Costs were calculated based on German diagnosis-related group (DRG) fees per case. RESULTS: A total of 308 patients (154 per cohort) with a median age of 62.6 years (IQR 52.5-70.8) were analyzed. AL was observed in ten patients (6.5%) in the PC and 23 patients (14.9%) in the CC (OR 0.380, 95% CI 0.174-0.833; P = 0.016). SSI occurred in 14 patients (9.1%) in the PC and 30 patients in the CC (19.5%), representing a significant reduction in our SSI rate (P = 0.009). The cost-effectiveness analysis showed that SDD is highly effective in saving costs with a number needed to treat of 12 for AL and 10 for SSI. CONCLUSION: SDD significantly reduces the incidence of AL and SSI and saves costs for the general healthcare system.

Role of fluorescence imaging for intraoperative intestinal assessment in gynecological surgery: a systematic review.

BACKGROUND: Our aim was to review the current knowledge of the role of fluorescence imaging for intraoperative intestinal assessment in gynecological surgery. MATERIAL AND METHODS: A computer-based systematic review was performed from 2000 to 2020. All articles describing the use of indocyanine green (ICG) applied to bowel assessments in gynecology or endometriosis surgery were considered for review. RESULTS: ICG is an effective tool for assessing bowel vascularization, potentially preventing anastomotic leakage and recto-vaginal fistula and can therefore be useful for endometriosis surgery or bowel assessment in gynecological oncology procedures. Real-time characterization of the hypovascular pattern of endometriotic nodules has been associated with a larger nodule size and lower microvessel density, helping surgeons choose the best transecting line and the most appropriate technique. ICG angiography allows for a laparoscopic and intrarectal bowel assessment, which can act as a double check of bowel perfusion, enabling the assessment of mucosa vascularization. ICG fluorescence can guide intraoperative decision-making after intestinal anastomosis, discoid resection, and rectal shaving, preventing anastomotic leakage and postoperative recto-vaginal fistula in low anterior resections. CONCLUSIONS: ICG angiography provides a better intestinal assessment. Larger, prospective, randomized controlled studies are needed to validate the technique and confirm these encouraging results.

Cost analysis of indocyanine green fluorescence angiography for prevention of anastomotic leakage in colorectal surgery.

BACKGROUND: Indocyanine green, near infrared, fluorescence angiography (ICG-FA) is increasingly adopted in colorectal surgery for intraoperative tissue perfusion assessment to reduce anastomotic leakage rates. However, the economic impact of this intervention has not been investigated. This study is a cost analysis of the routine use of ICG-FA in colorectal surgery from the hospital payer perspective. METHODS: A decision analysis model was developed for colorectal resections considering two scenarios: resection without using ICG-FA and resection with intraoperative ICG-FA for anastomotic perfusion assessment. Incorporated into the model were the costs of ICG agent, fluorescence angiography equipment, surgery, anastomotic leak, and the leak rates with and without ICG-FA. All input data were derived from recent publications. RESULTS: The routine use of ICG-FA for colorectal anastomosis is cost saving when cost analysis is performed using the following base case assumptions: 8.6% leak rate without ICG-FA, odds ratio of 0.46 for reduction of leakage with ICG-FA (4.8% leak rate relative to 8.6% base case), cost of ICG-FA of $250, and incremental cost of leak, not requiring reoperation, of $9,934.50. In one-way sensitivity analyses, routine use of ICG-FA was cost saving if the cost of an anastomotic leak is more than $5616.29, the cost of ICG-FA is less than $634.44, the leak rate (without ICG-FA) is higher than 4.9%, or the odds ratio for reduction of leak with ICG-FA is less than 0.69. There is a per-case saving of $192.22 with the use of ICG-FA. CONCLUSION: Using the best available evidence and most conservative base case values, routine use of ICG-FA in colorectal surgery was found to be cost saving. Since the evidence suggests there is a reduction in leak rate, the routine use of ICG-FA is a dominating strategy. However, the overall quality of evidence is low and there is a clear need for prospective, randomized controlled trials.

Multisensor perfusion assessment cohort study: Preliminary evidence toward a standardized assessment of indocyanine green fluorescence in colorectal surgery.

BACKGROUND: Traditional methods of assessing colonic perfusion are based on the surgeon's visual inspection of tissue. Fluorescence angiography provides qualitative information, but there remains disagreement on how the observed signal should be interpreted. It is unclear whether fluorescence correlates with physiological properties of the tissue, such as tissue oxygen saturation. The aim of this study was to correlate fluorescence intensity and colonic tissue oxygen saturation. METHODS: Prospective cohort study performed in a single academic tertiary referral center. Patients undergoing colorectal surgery who required an anastomosis underwent dual-modality perfusion assessment of a segment of bowel before transection and creation of the anastomosis, using near-infrared and multispectral imaging. Perfusion was assessed using maximal fluorescence intensity measurement during fluorescence angiography, and its correlation with tissue oxygen saturation was calculated. RESULTS: In total, 18 patients were included. Maximal fluorescence intensity occurred at a mean of 101 seconds after indocyanine green injection. The correlation coefficient was 0.73 (95% confidence interval of 0.65-0.79) with P < .0001, showing a statistically significant strong positive correlation between normalized fluorescence intensity and tissue oxygen saturation. The use of time averaging improved the correlation coefficient to 0.78. CONCLUSION: Fluorescence intensity is a potential surrogate for tissue oxygenation. This is expected to lead to improved decision making when transecting the bowel and, consequently, a reduction in anastomotic leak rates. A larger, phase II study is needed to confirm this result and form the basis of computational algorithms to infer biological or physiological information from the fluorescence imaging data.

Clinical utility of near-infrared perfusion assessment of the gastric tube during Ivor Lewis esophagectomy.

BACKGROUND: Anastomotic leakage (AL) after Ivor Lewis esophagectomy with intrathoracic anastomosis carries a significant morbidity. Adequate perfusion of the gastric tube (GT) is an important predictor of anastomotic integrity. Recently, near infrared fluorescent (NIRF) imaging using indocyanine green (ICG) was introduced in clinical practice to evaluate tissue perfusion. We evaluated the feasibility and efficacy of GT indocyanine green angiography (ICGA) after Ivor Lewis esophagectomy. METHODS: This retrospective analysis used data from a prospectively kept database of consecutive patients who underwent Ivor Lewis (IL) esophagectomy with GT construction for cancer between January 2016 and December 2020. Relevant outcomes were feasibility, ICGA complications and the impact of ICGA on AL. RESULTS: 266 consecutive IL patients were identified who matched the inclusion criteria. The 115 patients operated with perioperative ICGA were compared to a control group in whom surgery was performed according to the standard of care. ICGA perfusion assessment was feasible and safe in all 115 procedures and suggested a poorly perfused tip in 56/115 (48.7%) cases, for which additional resection was performed. The overall AL rate was 16% (43/266), with 12% (33/266) needing an endoscopic our surgical intervention and 6% (17/266) needing ICU support. In univariable and multivariable analyses, ICGA was not correlated with the risk of AL (ICGA:14.8% vs non-ICGA:17.2%, p = 0.62). However, poor ICGA perfusion of the GT predicted a higher AL rate, despite additional resection of the tip (ICGA poorly perfused: 19.6% vs ICG well perfused: 10.2%, p = 0.19). CONCLUSIONS: ICGA is safe and feasible, but did not result in a reduction of AL. The interpretation and necessary action in case of perioperative presence of ischemia on ICGA have yet to be determined. Prospective randomized trials are warranted to analyze its benefit on AL in esophageal surgery. Trial registration Ethical approval for a prospective esophageal surgery database was granted by the Ethical committee of the Ghent University Hospital. Belgian registration number: B670201111232. Ethical approval for this retrospective data analysis was granted by our institutional EC. REGISTRATION NUMBER: BC-09216.