Indocyanine green (ICG) is a relatively non‑toxic fluorescent dye with a history of safe use, which has fueled the development of new applications for ICG. Research on the use of ICG near‑infrared light (NIRL) fluorescence imaging during oncologic surgery has increased, revealing its role in tumor identification and localization, lymph node navigational resection and blood perfusion assessment. The purpose of the present review was to provide a comprehensive overview of advances in the clinical application of ICG NIRL fluorescence imaging during gastrointestinal tumor surgery. The present review discusses the techniques, outcomes, limitations and key considerations necessary for clinical practice, aiming to provide a valuable resource for professionals in the field.

Fluorescence imaging is critical for intraoperative intestinal perfusion assessment in colorectal surgery, yet its clinical adoption remains limited by subjective interpretation and lack of quantitative standards. This study introduces an integrated approach combining fluorescence curve analysis, biophysical modeling, and machine learning to improve intraoperative perfusion assessment.

Laparoscopic fluorescence videos from 68 low rectal cancer patients were analyzed, with 1,263 measurement points (15-20 per case) selected along colonic bands. Fluorescence intensity dynamics were extracted via color space transformation, video stabilization and image registration, then modeled using the Random Sample Consensus (RANSAC) algorithm and nonlinear least squares fitting to derive biophysical parameters. Three clinicians independently scored perfusion quality (0-100 scale) using morphological features and biophysical metrics. An XGBoost model was trained on these parameters to automate scoring.

The model achieved superior test performance, with a root mean square error (RMSE) of 2.47, a mean absolute error (MAE) of 1.99, and an R2 of 97.2%, outperforming conventional time-factor analyses. It demonstrated robust generalizability, showing no statistically significant prediction differences across age, diabetes, or smoking subgroups (P > 0.05). Clinically, low perfusion scores in distal anastomotic regions were significantly associated with postoperative complications (P < 0.001), validating the scoring system's clinical relevance and discriminative capacity. The automated software we developed completed analyses within 2 min, enabling rapid intraoperative assessment.

This framework synergistically enhances surgical evaluation through three innovations: (1) Biophysical modeling quantifies perfusion dynamics beyond time-based parameters; (2) Machine learning integrates multimodal data for surgeon-level accuracy; (3) Automated workflow enables practical clinical translation. By addressing limitations of visual assessment through quantitative, rapid, and generalizable analysis, this method advances intraoperative perfusion monitoring and decision-making in colorectal surgery.

Performing a bowel anastomosis is a critical step in colorectal resection. Assessing the risk of anastomotic leakage remains challenging, even for experienced surgeons.

To evaluate the use of indocyanine green (ICG) fluorescence imaging in assessing perfusion at the anastomotic site before and after anastomosis and determine whether it helps reduce anastomotic leakages.

ICG-COLORAL is a prospective, randomized, multicenter study conducted from September 1, 2018, to December 31, 2023. Participants were recruited during preoperative outpatient clinic visits by clinicians not involved in the study, as well as by researchers. Participants were elective patients scheduled for laparoscopic resections, excluding low anterior resections, with planned primary anastomosis in 5 Finnish public hospitals experienced in laparoscopic colorectal surgery.

The intervention group received 5 mg of ICG intravenously before and after anastomosis formation. The fluorescence signal was assessed with a near-infrared-capable camera. The control group did not receive ICG fluorescence imaging.

The primary outcome measure was the anastomotic leak rate as detected by computed tomography.

Among 1136 patients in the intention-to-treat population, 526 (46.3%) were female and 610 (53.7%) male; they had a mean (SD) age of 70 (11) years, body mass index of 28 (5), and age-adjusted Charlson Comorbidity Index of 5 (3). Overall, the anastomotic leak rate was 5.8% (33/567) in the ICG fluorescence imaging group vs 7.9% (45/569) in the control group (odds ratio [OR], 0.73; 95% CI, 0.48-1.13; P = .16). For right-sided operations, the anastomotic leak rate with ICG fluorescence imaging was 5.9% (16/273) vs 6.7% (20/298) in the control group (OR, 0.87; 95% CI, 0.46-1.65). For left-sided operations, the anastomotic leak rate was 5.2% (14/267) with ICG fluorescence imaging vs 9.5% (23/243) without (OR, 0.55; 95% CI, 0.29-1.05). No patients reported adverse events related to ICG.

This study found that routine use of ICG fluorescence imaging does not significantly reduce the overall anastomotic leak rate in laparoscopic colorectal surgery if low anterior resections are excluded but may be beneficial in left-sided operations.

ClinicalTrials.gov Identifier: NCT03602677.

This study aimed to identify patient-specific risk factors and intraoperative findings obtained from indocyanine green fluorescence angiography (ICG-FA) and intraoperative colonoscopy (IOC), using a structured endoscopic grading scale, to guide surgical decisions and minimize the risk of anastomotic leakage in colorectal surgery. One hundred-eleven patients undergoing elective left-sided colorectal resections were evaluated intraoperatively using both ICG-FA and IOC, with anastomoses classified by a new endoscopic grading scale (Grades 1-5). Anastomoses classified as suboptimal (grade > 3) were taken down and reconstructed or repaired. The primary aim of the study was to determine the rate of anastomotic leakage (AL) using this integrated strategy and subsequently to identify patient-specific risk factors associated with AL. Among 111 patients, 102 patients (91.8%) at the IOC were classified as Grade 1, 4 patients (3.6%) as Grade 2, 4 patients (3.6%) as Grade 3, and 1 patient (0.9%) as Grade 4. The overall AL rate was 10.8% (12 patients). On multivariate logistic regression analysis, only anastomotic level ≤ 12 cm emerged as an independent risk factor of AL (OR 0.064, 95% CI 0.008-0.517, p = 0.010). Among patients who developed an AL, 3 (25%) required surgical intervention, the others were managed endoscopically or conservatively. An integrated approach involving ICG-FA and IOC may aid to construct a technically optimal colorectal anastomosis. Nevertheless, anastomotic leakage can still occur due to factors unrelated to intraoperative technique, particularly low anastomosis height. These factors should prompt routine consideration of protective loop ileostomy and pelvic drainage to mitigate AL clinical consequences.

Indocyanine green fluorescence imaging technology has been increasingly utilized in rectal surgery in recent years. As a safe tracer, indocyanine green can facilitate lymph node tracing, assess the blood supply at anastomotic sites, and localize tumour lesions during laparoscopic surgery, thereby resulting in favourable outcomes. This technology helps surgeons to achieve more precise diagnoses and treatments in laparoscopic procedures, thus ultimately benefiting patients. However, the current application of indocyanine green fluorescence imaging technology still lacks standardized regulations, and certain effects remain contentious. This study provides a comprehensive review of the application of indocyanine green in laparoscopic surgery for rectal cancer based on the pertinent literature.

Indocyanine green fluorescence angiography (ICGFA) during colorectal surgery associates with reduced post-operative anastomotic complication rates. Because its interpretation is subjective, quantification has been proposed to address inter-user variability. This study reviews the published literature regarding ICGFA quantification during colorectal surgery with a focus on impactful clinical deployment.

A systematic review was performed of English language publications regarding clinical studies of ICGFA quantification in colorectal surgery in PubMed, Scopus, Web of Science and Cochrane Library on 29th August 2024, updated to 18th November 2024, following PRISMA guidelines. Newcastle Ottawa scale (NOS) was used to assess quality.

A total of 1428 studies were screened with 22 studies (1469 patients) selected. There was significant heterogeneity of ICGFA methodology, quantification methods and parameter selection and only three studies were NOS "high" quality. Extracorporeal application was most common. Four studies (154 patients) conducted real-time ICGFA analyses (others were post hoc) and four utilised artificial intelligence methods. Eleven studies only included patients undergoing left-sided resection (six focusing specifically on rectal resections). Only one study employed the quantification method to guide intra-operative decision-making regarding colonic transection. Twenty-six different perfusion parameters were assessed, with time from injection to visible fluorescence and maximum intensity the most commonly (but not only) correlated parameters regarding anastomotic complication (n = 18). Other grounding correlates were tissue oxygenation (n = 3, two with hyperspectral imagery), metabolites (n = 2) and surgeon interpretation (n = 5).

Quantification of the ICGFA signal for colorectal surgery is feasible but has so far seen limited academic advancement beyond feasibility.

Anastomotic leakage (AL) is a major complication in colorectal surgery, particularly following rectal cancer surgery, necessitating effective prevention strategies. The increasing frequency of colorectal resections and anastomoses during cytoreductive surgery (CRS) for peritoneal carcinomatosis further complicates this issue owing to the diverse patient populations with varied tumor distributions and surgical complexities. This study aims to assess and compare AL incidence and associated risk factors across conventional colorectal cancer surgery (CRC), gastrointestinal CRS (GI-CRS), and ovarian CRS (OC-CRS), with a secondary focus on evaluating the role of protective ostomies.

A retrospective analysis was performed on 1324 patients undergoing CRC, GI-CRS, and OC-CRS between January 2015 and December 2022. Multivariate analysis was utilized to identify preoperative, intraoperative, and postoperative variables as potential AL risk factors.

The overall AL rate was 3.0% (40/1324), with no significant differences among the three groups. Distinct risk factors were identified for each group: CRC (preoperative chemoradiotherapy), GI-CRS (ECOG score ≥ 2, preoperative albumin < 30 mg/dL), and OC-CRS (BMI < 18 kg/m2, pelvic lymphadenectomy, preoperative albumin < 30 mg/dL, anastomosis distance < 10 cm, postoperative anemia). Protective ostomies did not reduce AL incidence, and a notable discrepancy exists between AL risk factors and those influencing protective ostomy decisions.

AL, while rare, remains a serious postoperative complication in CRC and CRS. Key risk factors include preoperative nutritional status and surgical details such as blood supply and anastomosis level. Each patient group presents unique risks, which must be carefully weighed when considering protective ileostomy.

Raman-based theranostics has demonstrated great potential for sensitive real-time imaging and treatment. However, these advanced materials, primarily depending on the SERS technique, encounter clinical concerns regarding substrate biosafety. Herein, we molecularly engineered a de novo substrate-free SICTERS small molecule, namely BTT-TPA (bis-thienyl-substituted benzotriazole selenadiazole derivative structures), possessing both ultrasensitive Raman signals and excellent photothermal effects based on self-stacking. The mechanistic studies confirm that BTT maintains the planar structure with polycyclic distorted vibrations required for SICTERS. TPA enhances the donor-acceptor interaction, yielding a Raman sensitivity of BTT higher than previously reported SICTERS molecules; it also acts as a molecular rotor, increasing the photothermal conversion efficiency to 67.44%, which is superior to most of the existing SERS-based photothermal materials. In the tumor model of mouse orthotopic colon cancer, BTT-TPA NPs demonstrate a great Raman imaging-guided photothermal therapy effect in eliminating primary and metastatic tumors, remarkably decreasing the recurrence rate. This work puts forward substrate-free SICTERS small molecules toward Raman-based theranostic applications in vivo.

Indocyanine green fluorescence angiography (ICGFA) during colorectal surgery either reassures surgeons regarding intestinal perfusion sufficiency or prompts changed surgical strategy by indicating unsuspected insufficiency. This study describes existing evidence supporting ICGFA use in colorectal surgery, particularly regarding impact on intraoperative decisions.

Searches were performed on PubMed, ScienceDirect, Scopus, Web of Science, Cochrane Collaboration databases on 5th December 2023, updated to 19th August 2024. Full English language publications of clinical studies in human patients undergoing colorectal resection with primary anastomosis with the use of ICGFA to assess bowel perfusion intraoperatively, with a control group, were included. Pooling of anastomotic leak (AL) rates was performed for primary outcome analysis with odds ratio (OR) and number-needed-to-treat (NNT) calculated regarding leak reduction.

45 studies comprising 14,333 patients were included, with 7 randomised controlled trials (2911 patients). Overall, AL rate was 6.8%, 4.5% with ICGFA and 8.5% without (OR:0.47, p < 0.001, NNT 23), increasing to 9.5%, 7.5% and 11.6%, respectively, in randomised controlled trials (OR:0.62, p < 0.01, NNT 25). In rectal resections, AL rate was 4.7% with ICGFA vs 11.5% without (OR: 0.38, p < 0.0001). 26 studies performed ICGFA before and after anastomosis formation and 19 used ICGFA only prior to bowel transection, with no significant difference of AL rate reduction on subgroup testing. ICGFA prompted a change in surgical plan in 8.4% of thirty-four studies reporting this. Interestingly, in these studies, leak rates overall were 3.7% when ICGFA matched surgeon judgement versus 5.7% when it prompted change (OR 0.51, p < 0.0025), versus 7.7% without (OR 0.45, p < 0.0001). In rectal resections, these figures were 5%, 8.8% (OR 0.42, p = 0.01) and 12.0% (OR0.39, p < 0.0001), respectively.

ICGFA colorectal perfusion assessment is associated with lower anastomotic leak rates, especially when confirming surgeons' judgement, and may so stratify patients post-operatively regarding subsequent anastomotic leak rate.

Indocyanine green (ICG), a near-infrared (NIR) fluorescent dye with unique photoluminescent properties, is a helpful tool in many medical applications. ICG produces fluorescence when excited by NIR light, enabling accurate tissue visualization and real-time imaging. This study investigates the fundamental processes behind ICG's photoluminescence as well as its present and possible applications in treatments and medical diagnostics. Fluorescence-guided surgery (FGS) has been transformed by ICG's capacity to visualize tumors, highlight blood flow, and facilitate lymphatic mapping, all of which have improved surgical accuracy and patient outcomes. Furthermore, the fluorescence of the dye is being studied for new therapeutic approaches, like photothermal therapy, in which NIR light can activate ICG to target and destroy cancer cells. We go over the benefits and drawbacks of ICG's photoluminescent qualities in therapeutic contexts, as well as current studies that focus on improving its effectiveness, security, and adaptability. More precise disease detection, real-time monitoring, and tailored therapy options across a variety of medical specialties are made possible by the ongoing advancement of ICG-based imaging methods and therapies. In the main part of our work, we strive to take into account the latest reports; therefore, we used clinical articles going back to 2020. However, for the sake of the theoretical part, the oldest article used by us is from 1995.

Decision-making in emergency settings is inherently complex, requiring surgeons to rapidly evaluate various clinical, diagnostic, and environmental factors. The primary objective is to assess a patient's risk for adverse outcomes while balancing diagnoses, management strategies, and available resources. Recently, indocyanine green (ICG) fluorescence imaging has emerged as a valuable tool to enhance surgical vision, demonstrating proven benefits in elective surgeries.

This consensus paper provides evidence-based and expert opinion-based recommendations for the standardized use of ICG fluorescence imaging in emergency settings.

Using the PICO framework, the consensus coordinator identified key research areas, topics, and questions regarding the implementation of ICG fluorescence-guided surgery in emergencies. A systematic literature review was conducted, and evidence was evaluated using the GRADE criteria. A panel of expert surgeons reviewed and refined statements and recommendations through a Delphi consensus process, culminating in final approval.

ICG fluorescence imaging, including angiography and cholangiography, improves intraoperative decision-making in emergency surgeries, potentially reducing procedure duration, complications, and hospital stays. Optimal use requires careful consideration of dosage and timing due to limited tissue penetration (5-10 mm) and variable performance in patients with significant inflammation, scarring, or obesity. ICG is contraindicated in patients with known allergies to iodine or iodine-based contrast agents. Successful implementation depends on appropriate training, availability of equipment, and careful patient selection.

Advanced technologies and intraoperative navigation techniques, such as ICG fluorescence-guided surgery, should be prioritized in emergency surgery to improve outcomes. This technology exemplifies precision surgery by enhancing minimally invasive approaches and providing superior real-time evaluation of bowel viability and biliary structures-areas traditionally reliant on the surgeon's visual assessment. Its adoption in emergency settings requires proper training, equipment availability, and standardized protocols. Further research is needed to evaluate cost-effectiveness and expand its applications in urgent surgical procedures.

Inadequate bowel perfusion is among risk factors for colorectal anastomotic leaks. Perfusion can be assessed with indocyanine green fluorescence angiography (ICG) during colon resections. Possible benefits from its systematic use in high-risk patients with rectal cancer remain inconsistent. This study aimed to evaluate the surgical modifications induced by ICG assessment during rectal cancer surgery and associated anastomotic leaks.

This prospective before and after cohort study was conducted in a single Canadian high-volume colorectal surgery center. Eligible patients were undergoing a low anterior resection for rectal cancer below 15 cm from the anal margin. Stapled and handsewn coloanal anastomoses were included. The experimental group was recruited prospectively, undergoing surgery using fluorescence angiography with ICG. The control group was built retrospectively from consecutive patients who had been operated on without ICG, prior to its implementation.

Each cohort included 113 patients. The use of ICG led to modifications from initial surgical plan in 10.6% of patients, with no occurrence of anastomotic leaks in this specific group. When comparing leak rates, using ICG seemed to be protective, but this could not be statistically proven, overall (13.3% vs. 6.2%, p = 0.07), nor for handsewn coloanal anastomoses (11.8% vs. 5.9%, p = 0.67). A lack of power could explain such non-significant results, especially with low overall anastomotic leak rates recorded.

ICG influenced ultimate proximal resection margin in a clinically relevant proportion of cases. It might be associated with reduced leak rates although not formally proven with this data. This technology is safe and easy to apply in high-volume colorectal centers.

Pancreatic trauma is a rare solid organ injury. Conservative treatment is often indicated in patients with no pancreatic duct injury, while patients with high-grade pancreatic damage most often require surgical intervention. Laparoscopic central pancreatectomy (LCP) is a parenchyma-sparing approach and can prevent endocrine and exocrine insufficiency after pancreatic resection. Indocyanine green (ICG) fluoroscopy can help the surgeon assess the blood supply of the target organ.

The case we describe here is a 33-year-old male patient who was transferred to our hospital due to blunt abdominal trauma caused by a car accident. The patient was hemodynamically stable on admission and was diagnosed with isolated pancreatic trauma by a multidisciplinary team that included radiologists, emergency physicians, and pancreatic surgeons. The patient then underwent emergency laparoscopic central pancreatectomy, during which we used ICG fluoroscopy to assess the blood perfusion of the damaged pancreas to determine the extent of resection. The patient developed a biochemical fistula (grade A pancreatic fistula) after surgery, and no other intervention was performed except for continuous drainage. The patient was discharged on postoperative day 13. At the 3-month follow-up, the patient did not present any clinical manifestations of pancreatic endocrine and exocrine insufficiency.

To the best of our knowledge, there have been no reports of ICG-guided emergency LCP for blunt abdominal trauma. In selected patients, emergency LCP is feasible and should be supported by a multidisciplinary team and performed by an experienced pancreatic surgeon with advanced laparoscopic skills.

Anastomotic leaks are a significant complication in colorectal surgery. Indocyanine green fluorescence angiography (ICG-FA) has been suggested as a method to reduce the risk. This meta-analysis aims to evaluate the effect of ICG-FA on reducing anastomotic leaks in colorectal surgery. This study follows PRISMA guidelines and is registered on PROSPERO (CRD42022370748). We conducted a comprehensive search of multiple databases and registers for randomized controlled trials (RCTs) comparing ICG-FA with standard methods in colorectal surgery. Data extraction and quality assessment were performed by two independent reviewers, with a third resolving disputes. Odds ratios (OR) and mean differences (MD) were calculated using comprehensive meta-analysis software, version 3. Heterogeneity and publication bias were assessed, and a sensitivity analysis was performed. The analysis included five RCTs with a total of 1369 patients from four countries. The ICG-FA was associated with a 45% reduction in the risk of overall anastomotic leaks (OR: 0.550, p = 0.012). Subgroup analysis showed a 47% reduction in leaks for low anastomoses (OR: 0.53, p = 0.143) and a 69% reduction in grade A leaks (OR: 0.31, p = 0.008). No significant effects were observed for grade B and C leaks, blood loss, surgery duration, hospital stay, mortality, postoperative ileus, reoperation, or surgical site infections. ICG-FA significantly reduces the overall risk of anastomotic leaks, especially grade A leaks, and shows a trend towards fewer leaks in low anastomosis. No significant impact was found on secondary outcomes. Further RCTs are needed to confirm these findings.

We investigated the impact of Indocyanine Green (ICG) angiography on reducing anastomotic leakage (AL) after elective left segmental colon resection, including transverse resection. While ICG is widely used in colorectal surgery to assess vascularization, its true effect on AL, particularly in left segmental resections, remains unclear.

This retrospective, monocentric cohort study included patients undergoing left and transverse colon resection from January 2017 to July 2023. Patients were divided into ICG and no-ICG groups. The primary outcome was AL, with secondary outcomes including postoperative morbidity and length of stay.

Of the 115 patients enrolled, 53 received ICG and 63 did not. AL occurred in 6 patients in the no-ICG group, but none in the ICG group. No significant correlation was found between ICG use and other confounding factors. Postoperative length of stay was also shorter in the ICG group.

The use of ICG was associated with a reduction in AL, with no cases in the ICG group. These findings suggest a potential benefit of ICG, warranting confirmation in future large-scale studies.

clinicaltrial.gov (NCT05981937).

Despite spectacular visuals and the seemingly convincing rationale of using indocyanine-green-enhanced fluorescence in assessing bowel perfusion during colorectal resections, a lingering sense of subjectivity remains in the challenge of quantifying this fluorescence. This prospective study analyzed the application of O2C® spectrophotometry to quantify zones of fluorescence on the large bowel during low anterior resection.

Patients receiving a low anterior resection for cancer of the mid- and lower rectum were enrolled in this observational prospective study between February 2020 and December 2022. O2C® blood-flow measurement was performed at three different zones of fluorescence intensity (optimal [O], sufficient [S], and absent [A]), visualized at the designated and already skeletonized site of colon transection. The primary end point was to assess whether the O2C® flow value exceeds 164 arbitrary units (AU) at the zone of optimal fluorescence. The secondary objective was to assess whether there were statistically significant differences in flow parameters between the three zones, thus confirming reproducibility of measurements.

A total of 40 patients were enrolled in this study. Of these, 38 patients remained for statistical analysis with regard to O2C® measurement of the fluorescence zones. The O2C® flow parameter measured at the zone of optimal fluorescence was greater than 164 AU in all cases (100%, p < 0.0001). There were statistically significant differences in flow parameters measured at the three different zones of fluorescence (O-S: p < 0.0001; O-A: p < 0.0001; S-A: p = 0.0023).

This study proves the feasibility and reproducibility of quantifying zones of indocyanine green (ICG)-enhanced fluorescence on the bowel. All O2C® flow measurements that were collected at the zone of optimal fluorescence exceeded 164 AU, thereby adding more evidence to this value as a suggested cut-off parameter in terms of bowel perfusion.

The objective of this systematic review and meta-analysis was to pool randomized trials of patients undergoing left-sided colorectal anastomosis, comparing the use of fluorescence perfusion imaging versus visual inspection in reducing anastomotic leaks.

Databases searched included PubMed, Cochrane Library, Scopus, CINHAL (EBSCO), and Google Scholar based on the concepts: randomized, colorectal, anastomotic leak, and fluorescence imaging. The risk of bias was assessed using RoB2 and the certainty of the evidence with the GRADE Pro tool. The analysis used the log odds ratio for dichotomous data with 95% confidence intervals. Back-transformation of the log odds to odds ratio was performed for the summary of findings. All syntheses used the Random-effects model.

Six randomized trials were included with 1949 patients and 204 events (leaks). Three trials included exclusively rectal cancer patients, while the other three involved benign and malignant pathologies of the sigmoid and rectum. The use of ostomy and preoperative radiation was variable. None of the studies had a high risk of bias. The pooled odds ratio for anastomotic leak reduction with Indocyanine Green (ICG) fluorescence was 0.586 (95% CI: 0.434-0.792). An absolute reduction of 4.7% in leak rates was observed, with no statistical heterogeneity (I2 = 0; p = 0.529). Due to clinical heterogeneity, the quality of evidence was rated moderate.

The use of ICG is associated with reduced leak rates following left-sided colorectal anastomosis with moderate confidence. ICG may be considered a standard of care given the clinically significant benefit in decreasing anastomotic leaks.

Near infrared (NIR) analysis of tissue perfusion via indocyanine green fluorescence assessment is performed clinically during surgery for a range of indications. Its usefulness can potentially be further enhanced through the application of interpretable artificial intelligence (AI) methods to improve dynamic interpretation accuracy in these and also open new applications. While its main use currently is for perfusion assessment as a tissue health check prior to performing an anastomosis, there is increasing interest in using fluorophores for cancer detection during surgical interventions with most research being based on the paradigm of static imaging for fluorophore uptake hours after preoperative dosing. Although some image boosting and relative estimation of fluorescence signals is already inbuilt into commercial NIR systems, fuller implementation of AI methods can enable actionable predictions especially when applied during the dynamic, early inflow-outflow phase that occurs seconds to minutes after ICG (or indeed other fluorophore) administration. Already research has shown that such methods can accurately differentiate cancer from benign tissue in the operating theatre in real time in principle based on their differential signalling and could be useful for tissue perfusion classification more generally. This can be achieved through the generation of fluorescence intensity curves from an intra-operative NIR video stream. These curves are processed to adjust for image disturbances and curve features known to be influential in tissue characterisation are extracted. Existing machine learning based classifiers can then use these features to classify the tissue in question according to prior training sets. The use of this interpretable methodology enables accurate classification algorithms to be built with modest training sets in comparison to those required for deep learning modelling in addition to achieving compliance with medical device regulations. Integration of the multiple algorithms required to achieve this classification into a desktop application or medical device could make the use of this method accessible and useful to (as well as useable by) surgeons without prior training in computer technology. This document details some technical and functional design considerations underlying such a novel recommender system to advance the foundational concept and methodology as software as medical device for in situ cancer characterisation with relevance more broadly also to other tissue perfusion applications.

The aim of this study is to analyze the impact of different surgical techniques used to preserve the inferior mesenteric artery on patient outcomes following left colonic resection.

A search was conducted in PubMed, Embase and Web of Science, founding 4795 articles. The review was registered on PROSPERO (registration number: CRD42024572291).

Eleven articles published between 2001 and 2023, including 989 patients were the object of the present systematic review. Two hundred sixty-two patients (26.5%) underwent Valdoni's technique (Group A), which involves the skeletonization of the IMA, 272 (27.5%) underwent tubular resection (Group B), and 455 (46%) underwent peripheral dissection on sigmoid vessels (Group C). Laparoscopic surgery was predominant in Groups B (100%) and C (94.7%), while Group A had fewer laparoscopic procedures (44.6%). Patients in Group A experienced longer operative times (174.5 ± 27.4 min) and hospital stays (11.4 ± 3.6 days) compared to Groups B and C (165.9 min and 152.35 ± 46.9 min; 8.4 ± 5.7 days and 8.3 ± 3.6 days, respectively). Group A exhibited higher rates of anastomotic leakage (5%) compared to Group C (1.1%) and a higher incidence of bleeding (13%) compared to Group B (1.8%).

Valdoni's technique is less favourable for IMA preservation in left colon resection for diverticular disease. Peripheral dissection of sigmoid vessels or tubular resection is recommended for IMA preservation in this context.

Anastomotic leakage is a severe postoperative complication in colorectal surgery and compromised bowel perfusion is considered a major contributing factor. Conventional methods to assess bowel perfusion have a low predictive value for anastomotic leakage. We therefore aimed to evaluate the efficacy of real-time assessment with near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) in the prevention of anastomotic leakage.

This multicentre, randomised, controlled, phase 3 trial was done in eight hospitals in the Netherlands. We included adults (aged >18 years) who were scheduled for laparoscopic or robotic colorectal surgery (with planned primary anastomosis) for benign and malignant diseases. Preoperatively, patients were randomly assigned (1:1) to fluorescence-guided bowel anastomosis (FGBA) or conventional bowel anastomosis (CBA) by variable block randomisation (block sizes 4, 6, and 8) and stratified by site. The operating surgeon and investigators analysing the data were not masked to group assignment. Patients were unmasked after the surgical procedure or after study end. In the FGBA group, surgeons marked anastomosis levels per conventional perfusion assessment and then administered 5 mg of ICG by 2 mL intravenous bolus. They assessed bowel perfusion using NIR fluorescence imaging and adjusted (or kept) transection lines accordingly. Only conventional methods for bowel perfusion assessment were used in the CBA group. The primary outcome was the difference in the rate of clinically relevant anastomotic leakage (ie, requiring active therapeutic intervention but manageable without reoperation [grade B] or requiring reoperation [grade C], per the International Study Group of Rectal Cancer) between the FGBA group and the CBA group within 90 days post-surgery. The primary outcome and safety were assessed in the intention-to-treat population. This study was registered with ToetsingOnline.nl (NL7502) and ClinicalTrials.gov (NCT04712032) and is complete.

Between July 2, 2020, and Feb 21, 2023, 982 patients were enrolled, of whom 490 were assigned to FGBA and 492 were assigned to CBA. After excluding 51 patients, the intention-to-treat population comprised 931 (463 assigned FGBA and 468 assigned CBA). Patients had a median age of 68·0 years (IQR 59·0-75·0) and 485 (52%) were male and 446 (48%) were female. Ethnicity data were not available. The overall 90-day rate of clinically relevant anastomotic leakage was not significantly different between the FGBA group (32 [7%] of 463 patients) and the CBA group (42 [9%] of 468 patients; relative risk 0·77 [95% CI 0·50-1·20]; p=0·24). No adverse events related to ICG use were observed. 313 serious adverse events in 229 (25%) patients were at 90-day follow-up (159 serious adverse events in 113 [24%] patients in the FGBA group and 154 serious adverse events in 116 [25%] patients in the CBA group). 18 (2%) people died by 90 days (ten in the FGBA group and eight in the CBA group).

ICG NIR fluorescence imaging did not reduce 90-day anastomotic leakage rates in this trial across all types of colorectal surgeries. Further research should be done in subgroups, such as rectosigmoid resections, for which evidence suggests ICG NIR might be beneficial.

Olympus Medical, Diagnostic Green, and Intuitive Foundation.

Anastomotic leak is a relatively common and debilitating complication. Colorectal leak rates vary widely in the literature, ranging from 1% to 20%. In modern surgical practice, there is much emphasis on the use of indocyanine green (ICG). This is a fluorescent dye administered intravenously to locate and predict an adequate line of anastomosis. We sought to analyse the current literature and supporting evidence behind the use of ICG in the context of elective colorectal surgery.

A literature search was conducted for papers published between January 1991 and December 2022 concerning the use of ICG in colorectal surgery. Data on anastomotic leak, overall complication rate, operative time and involvement of artificial intelligence (AI) were compared.

A total of 24 studies were selected, including 3 randomised controlled trials. There was an anastomotic leak rate of 4.3% in cases with ICG administration compared with 9.5% in the control group (p<0.00001). Seven studies mentioned overall complication rates. These were lower in the ICG cohort than in the control group (15.5% vs 24.5%). There was no significant correlation between ICG use and operative time (p=0.78). Five studies looked at AI, with results suggesting that use of AI leads to much better accuracy in ICG metric analysis. However, the current literature is still inconclusive.

While there is strong evidence behind ICG use in the existing literature, more randomised controlled trials are required for better recommendations. AI in ICG metric interpretation has proved to be difficult owing to interpatient variability. Nevertheless, new data suggest better understanding and standardisation.

Fluorescence imaging is a real-time intraoperative navigation modality to enhance surgical vision and it can guide emergency surgeons while performing difficult, high-risk surgical procedures. The aim of this study is to assess current knowledge, attitudes, and practices of emergency surgeons in the use of indocyanine green (ICG) in emergency settings. Between March 08, 2023 and April 10, 2023, a questionnaire composed of 27 multiple choice and open-ended questions was sent to 200 emergency surgeons who had previously joined the ARtificial Intelligence in Emergency and trauma Surgery (ARIES) project promoted by the WSES. The questionnaire was developed by an emergency surgeon with an interest in advanced technologies and artificial intelligence. The response rate was 96% (192/200). Responders affirmed that ICG fluorescence can support the performance of difficult surgical procedures in the emergency setting, particularly in the presence of severe inflammation and in evaluating bowel viability. Nevertheless, there were concerns regarding accessibility and availability of fluorescence imaging in emergency settings. Eighty-seven out of 192 (45.3%) respondents have a fluorescence imaging system of vision for both elective and emergency surgical procedures; 32.3% of respondents have this system solely for elective procedures; 21.4% of respondents do not have this system, 15% do not have experience with it, and 38% do not use this imaging in emergency surgery. Less than 1% (2/192) affirmed that ICG fluorescence changed always their intraoperative decision-making. Precision surgery effectively tailors surgical interventions to individual patient characteristics using advanced technology, data analysis and artificial intelligence. ICG fluorescence can serve as a valid and safe tool to guide emergency surgery in different scenarios, such as intestinal ischemia and severe acute cholecystitis. Due to the lack of high-level evidence within this field, a consensus of expert emergency surgeons is needed to encourage stakeholders to increase the availability of fluorescence imaging systems and to support emergency surgeons in implementing ICG fluorescence in their daily practice.

Anastomotic leakage (AL) is a dreaded complication following colorectal cancer surgery, impacting patient outcome and leads to increasing healthcare consumption as well as economic burden. Bowel perfusion is a significant modifiable factor for anastomotic healing and thus crucial for reducing AL.

The study aimed to calculate a cut-off value for quantified laser speckle perfusion units (LSPUs) in order to differentiate between ischemic and well-perfused tissue and to assess inter-observer reliability.

LSCI was performed using a porcine ischemic small bowel loop model with the PerfusiX-Imaging® system. An ischemic area, a well-perfused area, and watershed areas, were selected based on the LSCI colormap. Subsequently, local capillary lactate (LCL) levels were measured. A logarithmic curve estimation tested the correlation between LSPU and LCL levels. A cut-off value for LSPU and lactate was calculated, based on anatomically ischemic and well-perfused tissue. Inter-observer variability analysis was performed with 10 observers.

Directly after ligation of the mesenteric arteries, differences in LSPU values between ischemic and well-perfused tissue were significant (p < 0.001) and increased significantly throughout all following measurements. LCL levels were significantly different (p < 0.001) at both 60 and 120 min. Logarithmic curve estimation showed an R2 value of 0.56 between LSPU and LCL values. A LSPU cut-off value was determined at 69, with a sensitivity of 0.94 and specificity of 0.87. A LCL cut-off value of 3.8 mmol/L was found, with a sensitivity and specificity of 0.97 and 1.0, respectively. There was no difference in assessment between experienced and unexperienced observers. Cohen's Kappa values were moderate to good (0.52-0.66).

Real-time quantification of LSPUs may be a feasible intraoperative method to assess tissue perfusion and a cut-off value could be determined with high sensitivity and specificity. Inter-observer variability was moderate to good, irrespective of prior experience with the technique.

Current evidence about intraoperative anastomotic testing after left-sided colorectal resections is still controversial. The aim of this study was to analyze the impact of Indocyanine Green fluorescent angiography (ICG-FA) and air-leak test (ALT) over standard assessment on anastomotic leakage (AL) rates according to surgeon's perception of anastomosis perfusion and/or integrity in clinical practice.

A database of 2061 patients who underwent left-sided colorectal resections was selected from patients enrolled in a prospective multicenter study. It was retrospectively analyzed through a multi-treatment machine-learning model considering standard visual assessment (NW; No. = 899; 43.6%) as the reference treatment arm, compared to ICG-FA alone (WP; No. = 409; 19.8%), ALT alone (WI; No. = 420; 20.4%) or both (WPI; No. = 333; 16.2%). Twenty-four covariates potentially affecting the outcomes were included and balanced into the model within the subgroups. The primary endpoint was AL, the secondary endpoints were overall morbidity (OM), major morbidity (MM), reoperation for AL, and mortality. All the results were reported as odds ratio (OR) with 95% confidence intervals (95%CI).

The WPI subgroup showed significantly higher AL risk (OR 1.91; 95% CI 1.02-3.59; p 0.043), MM risk (OR 2.35; 95% CI 1.39-3.97; p 0.001), and reoperation for AL risk (OR 2.44; 95% CI 1.12-5.31; p 0.025). No other significant differences were recorded.

This study showed that the surgeons' perception of both anastomotic perfusion and integrity (WPI subgroup) was associated to a significantly higher risk of AL and related morbidity, notwithstanding the extensive use of both ICG-FA and ALT testing.

Acute diverticulitis (AD) is associated with relevant morbidity/mortality and is increasing worldwide, thus becoming a major issue for national health systems. AD may be challenging, as clinical relevance varies widely, ranging from asymptomatic picture to life-threatening conditions, with continuously evolving diagnostic tools, classifications, and management. A 33-item-questionnaire was administered to residents and surgeons to analyze the actual clinical practice and to verify the real spread of recent recommendations, also by stratifying surgeons by experience. CT-scan remains the mainstay of AD assessment, including cases presenting with recurrent mild episodes or women of child-bearing age. Outpatient management of mild AD is slowly gaining acceptance. A conservative management is preferred in non-severe cases with extradigestive air or small/non-radiologically drainable abscesses. In severe cases, a laparoscopic approach is preferred, with a non-negligible number of surgeons confident in performing emergency complex procedures. Surgeons are seemingly aware of several options during emergency surgery for AD, since the rate of Hartmann procedures does not exceed 50% in most environments and damage control surgery is spreading in life-threatening cases. Quality of life and history of complicated AD are the main indications for delayed colectomy, which is mostly performed avoiding the proximal vessel ligation, mobilizing the splenic flexure and performing a colorectal anastomosis. ICG is spreading to check anastomotic stumps' vascularization. Differences between the two experience groups were found about the type of investigation to exclude colon cancer (considering the experience only in terms of number of colectomies performed), the size of the peritoneal abscess to be drained, practice of damage control surgery and the attitude towards colovesical fistula.

Technological advances are crucial for the optimization of gastric cancer surgery, and the success of any gastric cancer surgery is based on the correct and precise anatomical determination of the primary tumour and tissue structures. Real-time imaging-guided surgery is showing increasing potential and utility, mainly because it helps to aid intraoperative decision-making. However, intraoperative imaging faces many challenges in the field of gastric cancer. This article summarizes and discusses the following clinical applications of real-time optical imaging and fluorescence-guided surgery for gastric cancer: (1) the potential of quantitative fluorescence imaging in assessing tissue perfusion, (2) vascular navigation and determination of tumour margins, (3) the advantages and limitations of lymph node drainage assessment, and (4) identification of peritoneal metastases. In addition, preclinical study of tumour-targeted fluorescence imaging are discussed.

Background: Anastomotic leakage (AL) is one of the most feared complications in colorectal surgery, with an incidence of 12-39% and associated risk of mortality of 2-24%. The causes of AL and the ways to prevent it are currently under investigation. This study aims to verify if a quadruple assessment of colorectal anastomosis could reduce AL incidence. Methods: A retrospective analysis of prospectively collected data on rectal cancer surgery performed from January 2015 to December 2017 and from January 2021 to December 2023 at a tertiary referral cancer centre was performed. Demographics, clinicopathological features, short-term outcomes, recurrences, and survival were investigated. Results: A total of 293 patients were enrolled. AL incidence was lower in the quadruple assessment group than in the control group, reaching a statistically significant result (7.7% vs. 16%; p = 0.001). This result was also confirmed after a propensity score match analysis (PSM), in which the AL rate was lower in the quadruple assessment group (5.4% vs. 12.3%; p = 0.01). Conclusions: This study shows how the systematic implementation of a quadruple assessment when performing a colorectal anastomosis could increase awareness on anastomotic success and reduce the incidence of AL.

This manuscript aims to provide a better understanding of methods and techniques with which one can better quantify the impact of image-guided surgical technologies.

A literature review was conducted with regard to economic and technical methods of medical device evaluation in various countries. Attention was focused on applications related to image-guided interventions that have enabled procedures to be performed in a minimally invasive manner, produced superior clinical outcomes, or have become standard of care.

The review provides examples of successful implementations and adoption of image-guided surgical techniques, mostly in the field of neurosurgery. Failures as well as newly developed technologies still undergoing cost-efficacy analysis are discussed.

The field of image-guided surgery has evolved from solely using preoperative images to utilizing highly specific tools and software to provide more information to the interventionalist in real time. While deformations in soft tissue often preclude the use of such instruments outside of neurosurgery, recent developments in optical and radioactive guidance have enabled surgeons to better account for organ motion and provide feedback to the surgeon as tissue is cut. These technologies are currently undergoing value assessments in many countries and hold promise to improve outcomes for patients, surgeons, care teams, payors, and society in general.

The revolution that we are seeing in the world of surgery will determine the way we understand surgical approaches in coming years. Since the implementation of minimally invasive surgery, innovations have constantly been developed to allow the laparoscopic approach to go further and be applied to more and more procedures. In recent years, we have been in the middle of another revolutionary era, with robotic surgery, the application of artificial intelligence and image-guided surgery. The latter includes 3D reconstructions for surgical planning, virtual reality, holograms or tracer-guided surgery, where ICG-guided fluorescence has provided a different perspective on surgery. ICG has been used to identify anatomical structures, assess tissue perfusion, and identify tumors or tumor lymphatic drainage. But the most important thing is that this technology has come hand in hand with the potential to develop other types of tracers that will facilitate the identification of tumor cells and ureters, as well as different light beams to identify anatomical structures. These will lead to other types of systems to assess tissue perfusion without the use of tracers, such as hyperspectral imaging. Combined with the upcoming introduction of ICG quantification, these developments represent a real revolution in the surgical world. With the imminent implementation of these technological advances, a review of their clinical application in general surgery is timely, and this review serves that aim.

Minimally invasive endoscopic surgery is growing in veterinary medicine, in large part, due to the advantages associated with reduced pain, potential for decreased complications, and increased visualization of structures through magnification and illumination. With advancing technologies, we can now improve upon natural "white light" endoscopy with fluorescence-guided imaging. Near-infrared (NIR) cameras allow for real-time, high-definition visualization of vessels, anatomic structures, and perfusion. New uses of NIR technologies during laparoscopy are continuing to grow for vascular, lymphatic, and oncologic-related techniques. Limitations exist, and future efforts need to determine optimal dosing, tissue-specific fluorophores, and veterinary-specific techniques.

Serum levels of procalcitonin and C-reactive protein (CRP) have been used to predict anastomotic leakage after colorectal surgery, but information is scarce in advanced ovarian cancer (AOC) surgery with bowel resection. This study aimed to assess the predictive value of procalcitonin and CRP in detecting anastomotic leakage after AOC surgery with bowel resection. The study also aimed to determine the optimal postoperative reference values and the best day for evaluating these markers.

This prospective, observational and multicentric trial included 92 patients with AOC undergoing debulking surgery with bowel resection between 2017 and 2020 in 10 reference hospitals in Spain. Procalcitonin and CRP levels were measured at baseline and on postoperative days 1-6. Receiver operating characteristic analysis was performed to evaluate the predictive value of procalcitonin and CRP at each postoperative day. Sensitivity, specificity, positive and negative predictive values were calculated.

Anastomotic leakage was detected in six patients (6.5%). Procalcitonin and CRP values were consistently higher in patients with anastomotic leakage at all postoperative days. The maximum area under the curve (AUC) for procalcitonin was observed at postoperative day 1 (AUC = 0.823) with a cutoff value of 3.8 ng/mL (83.3% sensitivity, 81.3% specificity). For CRP, the maximum AUC was found at postoperative day 3 (AUC = 0.833) with a cutoff level of 30.5 mg/dL (100% sensitivity, 80.4% specificity).

Procalcitonin and C-reactive protein are potential biomarkers for early detection of anastomotic leakage after ovarian cancer surgery with bowel resection. Further prospective studies with a larger sample size are needed to confirm these findings.

Application of indocyanine green (ICG) fluorescence has led to new developments in gastrointestinal surgery. However, little is known about the use of ICG for the diagnosis of postoperative gut leakage (GL). In addition, there is a lack of rapid and intuitive methods to definitively diagnose postoperative GL.

To investigate the effect of ICG in the diagnosis of anastomotic leakage in a surgical rat GL model and evaluate its diagnostic value in colorectal surgery patients.

Sixteen rats were divided into two groups: GL group (n = 8) and sham group (n = 8). Approximately 0.5 mL of ICG (2.5 mg/mL) was intravenously injected postoperatively. The peritoneal fluid was collected for the fluorescence test at 24 and 48 h. Six patients with rectal cancer who had undergone laparoscopic rectal cancer resection plus enterostomies were injected with 10 mL of ICG (2.5 mg/mL) on postoperative day 1. Their ostomy fluids were collected 24 h after ICG injection to identify the possibility of the ICG excreting from the peripheral veins to the enterostomy stoma. Participants who had undergone colectomy or rectal cancer resection were enrolled in the diagnostic test. The peritoneal fluids from drainage were collected 24 h after ICG injection. The ICG fluorescence test was conducted using OptoMedic endoscopy along with a near-infrared fluorescent imaging system.

The peritoneal fluids from the GL group showed ICG-dependent green fluorescence in contrast to the sham group. Six samples of ostomy fluids showed green fluorescence, indicating the possibility of ICG excreting from the peripheral veins to the enterostomy stoma in patients. The peritoneal fluid ICG test exhibited a sensitivity of 100% and a specificity of 83.3% for the diagnosis of GL. The positive predictive value was 71.4%, while the negative predictive value was 100%. The likelihood ratios were 6.0 for a positive test result and 0 for a negative result.

The postoperative ICG test in a drainage tube is a valuable and simple technique for the diagnosis of GL. Hence, it should be employed in clinical settings in patients with suspected GL.

Anastomotic dehiscence, a feared complication in colorectal surgery, motivates the search for effective strategies to mitigate its risk. This meta-analysis encompasses all published randomized trials investigating and comparing the impact of indocyanine green (ICG) angiography on this complication. With four studies and 1,109 patients, the intraoperative ICG angiography group demonstrated a significant reduction in the overall rate of anastomotic dehiscence compared to the non-angiography group (7.3% vs. 11.5%; OR: 0.6; 95% CI: 0.4-0.9; p = 0.03). These differences were maintained in rectal surgery subgroup, with no prolongation of surgical time or increase in morbidity and mortality. There were no differences in the left colon surgery group. The evidence provided by this meta-analysis would support the effectiveness of ICG angiography in reducing the incidence of anastomotic leakage in colorectal surgery, advocating for its integration into routine surgical practice.

Intraoperative indocyanine green fluorescence angiography (ICGFA) aims to reduce colorectal anastomotic complications. However, signal interpretation is inconsistent and confounded by patient physiology and system behaviours. Here, we demonstrate a proof of concept of a novel clinical and computational method for patient calibrated quantitative ICGFA (QICGFA) bowel transection recommendation.

Patients undergoing elective colorectal resection had colonic ICGFA both immediately after operative commencement prior to any dissection and again, as usual, just before anastomotic construction. Video recordings of both ICGFA acquisitions were blindly quantified post hoc across selected colonic regions of interest (ROIs) using tracking-quantification software and computationally compared with satisfactory perfusion assumed in second time-point ROIs, demonstrating 85% agreement with baseline ICGFA. ROI quantification outputs detailing projected perfusion sufficiency-insufficiency zones were compared to the actual surgeon-selected transection/anastomotic construction site for left/right-sided resections, respectively. Anastomotic outcomes were recorded, and tissue lactate was also measured in the devascularised colonic segment in a subgroup of patients. The novel perfusion zone projections were developed as full-screen recommendations via overlay heatmaps.

No patient suffered intra- or early postoperative anastomotic complications. Following computational development (n = 14) the software recommended zone (ROI) contained the expert surgical site of transection in almost all cases (Jaccard similarity index 0.91) of the nine patient validation series. Previously published ICGFA time-series milestone descriptors correlated moderately well, but lactate measurements did not. High resolution augmented reality heatmaps presenting recommendations from all pixels of the bowel ICGFA were generated for all cases.

By benchmarking to the patient's own baseline perfusion, this novel QICGFA method could allow the deployment of algorithmic personalised NIR bowel transection point recommendation in a way fitting existing clinical workflow.

Indocyanine green (ICG), a well-known molecule employed in medicine for over five decades, has emerged as a versatile dye widely embraced across various surgical disciplines. In gynecologic oncology, its prevalent use revolves around the detection of sentinel lymph nodes. However, the true potential of ICG extends beyond this singular application, owing to its pragmatic utility, cost-effectiveness, and safety profile. Furthermore, ICG has been introduced in the theranostic landscape, marking a significant juncture in the evolution of its clinical utility. This narrative review aims to describe the expanding horizons of ICG fluorescence in gynecologic oncology, beyond the sentinel lymph node biopsy. The manifold applications reported within this manuscript include: 1) lymphography; 2) angiography; 3) nerve visualization; 4) ICG-driven resections; and 5) theranostic. The extensive exploration across these numerous applications, some of which are still in the preclinical phase, serves as a hypothesis generator, aiming to stimulate the development of clinical studies capable of expanding the use of this drug in our field, enhancing the care of gynecological cancer patients.

Anastomotic leakage (AL) is defined as the failure of complete healing or disruption of the anastomosis subsequent to rectal cancer surgery, resulting in the extravasation of intestinal contents into the intra-abdominal or pelvic cavity. It is a serious complication of rectal cancer surgery, accounting for a considerable increase in morbidity and mortality. The use of fluorescence imaging technology in surgery allows surgeons to better evaluate blood perfusion. However, the conclusions of some existing studies are not consistent, so a consensus on whether the near-infrared indocyanine green (NIR-ICG) imaging system can reduce the incidence of AL is needed.

This POSTER trial is designed as a multicentre, prospective, randomised controlled clinical study adhering to the "population, interventions, comparisons, outcomes (PICO)" principles. It is scheduled to take place from August 2019 to December 2024 across eight esteemed hospitals in China. The target population consists of patients diagnosed with rectal cancer through pathological confirmation, with tumours located≤10 cm from the anal verge, eligible for laparoscopic surgery. Enrolled patients will be randomly assigned to either the intervention group or the control group. The intervention group will receive intravenous injections of ICG twice, with intraoperative assessment of anastomotic blood flow using the near-infrared NIR-ICG system during total mesorectal excision (TME) surgery. Conversely, the control group will undergo conventional TME surgery without the use of the NIR-ICG system. A 30-day follow-up period postoperation will be conducted to monitor and evaluate occurrences of AL. The primary endpoint of this study is the incidence of AL within 30 days postsurgery in both groups. The primary outcome investigators will be blinded to the application of ICG angiography. Based on prior literature, we hypothesise an AL rate of 10.3% in the control group and 3% in the experimental group for this study. With a planned ratio of 2:1 between the number of cases in the experimental and control groups, and an expected 20% lost-to-follow-up rate, the initial estimated sample size for this study is 712, comprising 474 in the experimental group and 238 in the control group.

This study has been approved by Ethics committee of Beijing Friendship Hospital, Capital Medical University (approval number: 2019-P2-055-02). The results will be disseminated in major international conferences and peer-reviewed journals.

NCT04012645.