Peritoneal fluid indocyanine green test for diagnosis of gut leakage in anastomotic leakage rats and colorectal surgery patients.

BACKGROUND: 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. AIM: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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 tension "Bridging": a risk factor for anastomotic leakage following low anterior resection.

BACKGROUND: Excessive tension at the anastomosis contributes to anastomotic leakage (AL) in low anterior resection (LAR). However, the specific tension has not been measured. We assessed whether "Bridging," characterized by the proximal colon resembling a suspension bridge above the pelvic floor, is a significant risk factor for AL following LAR for rectal cancer. METHODS: This retrospective study reviewed the medical records and laparoscopic videos of 102 patients who underwent laparoscopic LAR using the double stapling technique at Yachiyo Hospital between January 2014 and December 2023. Patients were classified based on whether they had Bridging (tight or sagging) or were in a Resting state of the proximal colon, and the association between Bridging and AL was examined. RESULTS: AL occurred in 31.3% of the Tight Bridging group, 20% of the Sagging Bridging group, and 2.2% of the Resting group (P = 0.002). The incidence of AL was significantly higher in patients with Bridging than in those without (23.2% vs. 2.2%, P = 0.003). Multivariate analysis revealed that Bridging is an independent risk factor for AL (odds ratio = 6.97; 95% confidence interval: 1.45-33.6; P = 0.016). CONCLUSIONS: The presence of Bridging is a significant risk factor for AL following LAR for rectal cancer, suggesting the need for implementing preventive measures in patients with this condition.

Impact of Circular Stapler Size on the Risk of Anastomotic Complications in Patients With Left-sided Colorectal Cancer: A Propensity Score-matched Study.

Background/Aim: The present study examined the impact of circular stapler size on anastomotic complications, including leakage and stricture in patients undergoing double-stapling technique (DST) anastomosis for left-sided colon or rectal cancer. Patients and Methods: A total of 403 patients were enrolled in this study, with circular stapler sizes  of 25, 28, and 29 mm. Results: A small circular stapler (25 mm) was used in 170 cases (42.2%), and a medium-sized circular stapler (28/29 mm) was used in 233 cases (57.8%). After propensity score matching, there was no marked difference in the incidence of anastomotic leakage/stricture between the groups (13.9% vs. 10.9%, 3.0% vs. 1.0%, respectively). Conclusion: The size of the circular stapler was not associated with the incidence of anastomotic leakage or stricture in this cohort.

Prediction of Anastomotic Leakage in Esophageal Cancer Surgery: A Multimodal Machine Learning Model Integrating Imaging and Clinical Data.

RATIONALE AND OBJECTIVES: Surgery in combination with chemo/radiotherapy is the standard treatment for locally advanced esophageal cancer. Even after the introduction of minimally invasive techniques, esophagectomy carries significant morbidity and mortality. One of the most common and feared complications of esophagectomy is anastomotic leakage (AL). Our work aimed to develop a multimodal machine-learning model combining CT-derived and clinical data for predicting AL following esophagectomy for esophageal cancer. MATERIAL AND METHODS: A total of 471 patients were prospectively included (Jan 2010-Dec 2022). Preoperative computed tomography (CT) was used to evaluate celia trunk stenosis and vessel calcification. Clinical variables, including demographics, disease stage, operation details, postoperative CRP, and stage, were combined with CT data to build a model for AL prediction. Data was split into 80%:20% for training and testing, and an XGBoost model was developed with 10-fold cross-validation and early stopping. ROC curves and respective areas under the curve (AUC), sensitivity, specificity, PPV, NPV, and F1-scores were calculated. RESULTS: A total of 117 patients (24.8%) exhibited post-operative AL. The XGboost model achieved an AUC of 79.2% (95%CI 69%-89.4%) with a specificity of 77.46%, a sensitivity of 65.22%, PPV of 48.39%, NPV of 87.3%, and F1-score of 56%. Shapley Additive exPlanation analysis showed the effect of individual variables on the result of the model. Decision curve analysis showed that the model was particularly beneficial for threshold probabilities between 15% and 48%. CONCLUSION: A clinically relevant multimodal model can predict AL, which is especially valuable in cases with low clinical probability of AL.

Practical use of transanal decompression tube following the repair of fourth-degree perineal tears associated with vaginal delivery.

BACKGROUND: Fourth-degree perineal tears associated with vaginal delivery (PTAVD) occur in approximately 0.25 to 6% of vaginal deliveries. A persistent challenge in treating fourth-degree PTAVD is the high incidence of anastomotic leakage, leading to impaired quality of life, marked by incontinence, rectovaginal fistula, and painful sexual intercourse. Thus, effective interventions are necessary. Herein, we report our successful approach in repairing a fourth-degree PTAVD, involving the placement of a transanal decompression tube (TDT) during the early postoperative period. CASE PRESENTATION: Five patients underwent the repair of fourth-degree PTAVD by suturing the mucosal and muscular layers of the rectum, and the vaginal wall in layers. Subsequently, a TDT was placed in the rectum, positioned 10-15 cm from the anal verge. The TDT was allowed to drain spontaneously without suction. Gastrografin enema examination was performed through a TDT, followed by a computed tomographic scan on postoperative days 3-4. After unfavorable complications were ruled out, the TDT was removed and the patients were transitioned to a normal diet. RESULT: All patients showed favorable outcomes with no occurrence of vaginal fistula or incontinence. CONCLUSION: This simple intervention demonstrates potential efficacy in reducing anastomotic leakage following the repair of fourth-degree PTAVD.

Effectiveness of anastomotic reinforcement sutures in reducing anastomotic leakage risk after laparoscopic rectal cancer surgery: a pooled and integration analysis.

Background and objectives: Anastomotic leakage (AL) is one of the most serious complications after laparoscopic anus-preserving surgery for rectal cancer, which significantly prolongs the patient's hospital stay, leads to dysfunction, and even increases the patient's perioperative morbidity and mortality, and little is known about the effectiveness of anastomotic reinforcement sutures to prevent AL. Thus, this study was conducted to evaluate the efficacy of anastomotic reinforcement sutures as a means to prevent AL during laparoscopic surgery for rectal cancer. Methods: A comprehensive and systematic search was performed in the literature database by combining subject and free terms up to 10 October 2023. The overall literature included was integrated and analyzed using Stata 12.0 software and Review Manager version 5.4 software to assess the effect of anastomotic reinforcement sutures on the incidence of AL. Results: A total of 2,452 patients from 14 studies were included, and an integrated analysis showed that the use of anastomotic reinforcement sutures significantly reduced the incidence of AL [odds ratio (OR) = 0.26; 95% confidence interval (CI), 0.18-0.37; P < 0.00001; I2 = 0%]. However, the findings confirmed whether or not the anastomosis reinforced with sutures did not affect the incidence of anastomotic stenosis (OR = 0.69; 95% CI, 0.37-1.32; P = 0.27; I2 = 0%). We performed subgroup analyses of the results of the study, the randomized controlled studies (OR = 0.31; 95% CI, 0.15-0.65; P < 0.001) as well as retrospective studies (OR = 0.28; 95% CI, 0.19-0.41; P < 0.001), 3-0 sutures (OR = 0.28; 95% CI, 0.17-0.45; P < 0.001) versus 4-0 sutures (OR = 0.26; 95% CI, 0.13-0.53; P < 0.001), barbed wire sutures (OR = 0.26; 95% CI, 0.14-0.48; P < 0.001) versus non-barbed wire sutures (OR = 0.30; 95% CI, 0.20-0.46; P < 0.001), interrupted (OR = 0.30, 95% CI, 0.20-0.46; P < 0.001) versus continuous sutures (OR = 0.29, 95% CI, 0.16-0.51; P < 0.001) to the anastomosis, full-thickness suture (OR = 0.29; 95% CI, 0.16-0.51; P < 0.001) versus sutured with the seromuscular layer (OR = 0.27; 95% CI, 0.14-0.53; P < 0.001), anastomotic sutured in one (OR = 0.27; 95% CI, 0.14-0.53; P < 0.001) versus non-one circle (OR = 0.30; 95% CI, 0.20-0.44; P < 0.001), and reinforcing sutures to the dog-ear area (OR = 0.26; 95% CI, 0.14-0.50; P < 0.001) versus the non-dog-ear area (OR = 0.30; 95% CI, 0.20-0.45; P < 0.001), which have suggested that there is no significant difference between each other and that all of them reduce the incidence of AL. Conclusions: This study provides evidence that performing reinforcement suturing of the anastomosis during laparoscopic rectal surgery significantly lowers the incidence of postoperative AL but has no significant effect on anastomotic stenosis. It is important to note that further randomized controlled studies are required to confirm this conclusion. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42022368631.

Stenosis of the colorectal anastomosis after surgery for diverticulitis: A national retrospective cohort study.

AIM: The aim of this work was to investigate the association between early postoperative anastomotic leakage or pelvic abscess (AL/PA) and symptomatic anastomotic stenosis (SAS) in patients after surgery for left colonic diverticulitis. METHOD: This is a retrospective study based on a national cohort of diverticulitis surgery patients carried out by the Association Française de Chirurgie. The assessment was performed using path analyses. The database included 7053 patients operated on for colonic diverticulitis, with surgery performed electively or in an emergency, by open access or laparoscopically. Patients were excluded from the study analysis where there was (i) right-sided diverticulitis (the initial database included all consecutive patients operated on for colonic diverticulitis), (ii) no anastomosis was performed during the first procedure or (iii) missing information about stenosis, postoperative abscess or anastomotic leakage. RESULTS: Of the 4441 patients who were included in the final analysis, AL/PA occurred in 327 (4.6%) and SAS occurred in 82 (1.8%). AL/PA was a significant independent factor associated with a risk for occurrence of SAS (OR = 3.41, 95% CI = 1.75-6.66), as was the case for diverting stoma for ≥100 days (OR = 2.77, 95% CI = 1.32-5.82), while central vessel ligation proximal to the inferior mesenteric artery was associated with a reduced risk (OR = 0.41; 95% CI = 0.19-0.88). Diverting stoma created for <100 days or ≥100 days was also a factor associated with a risk for AL/PA (OR = 3.08, 95% CI = 2-4.75 and OR = 12.95, 95% CI = 9.11-18.50). Interestingly, no significant association between radiological drainage or surgical management of AL/PA and SAS could be highlighted. CONCLUSION: AL/PA was an independent factor associated with the risk for SAS. The treatment of AL/PA was not associated with the occurrence of anastomotic stenosis. Diverting stoma was associated with an increased risk of both AL/PA and SAS, especially if it was left for ≥100 days. Physicians must be aware of this information in order to decide on the best course of action when creating a stoma during elective or emergency surgery.

Thoracoscopic primary repair is useful for esophageal atresia with tracheoesophageal fistula in neonates with low body weight.

PURPOSE: The surgical indication of thoracoscopic primary repair for esophageal atresia with tracheoesophageal fistula is under debate. The current study aimed to investigate the outcome of thoracoscopic primary repair for esophageal atresia with tracheoesophageal fistula in patients weighing < 2000 g and those who underwent emergency surgery at the age of 0 day. METHODS: The surgical outcomes were compared between patients weighing < 2000 g and those weighing > 2000 g at surgery and between patients who underwent surgery at the age of 0 day and those who underwent surgery at age ≥ 1 day. RESULTS: In total, 43 patients underwent thoracoscopic primary repair for esophageal atresia with tracheoesophageal fistula. The surgical outcomes according to body weight were similar. Patients who underwent surgery at the age of 0 day were more likely to develop anastomotic leakage than those who underwent surgery at the age of ≥ 1 day (2 vs. 0 case, p = 0.02). Anastomotic leakage was treated with conservative therapy. CONCLUSION: Thoracoscopic primary repair is safe and useful for esophageal atresia with tracheoesophageal fistula even in newborns weighing < 2000 g. However, emergency surgery at the age of 0 day should be cautiously performed due to the risk of anastomotic leakage.

Procalcitonin and C-reactive protein as early predictors in patients at high risk of colorectal anastomotic leakage.

OBJECTIVE: To assess the diagnostic value of C-reactive protein (CRP) and procalcitonin (PCT) for anastomotic leakage (AL) following colorectal surgery. METHODS: We retrospectively analyzed data for patients who underwent colorectal surgery at our hospital between November 2019 and December 2023. CRP and PCT were measured postoperatively to compare patients with/without AL, and changes were compared between low- and high-risk groups. Receiver operating characteristic (ROC) curve analysis was used to assess the diagnostic accuracy of CRP and PCT to identify AL in high-risk patients. RESULTS: Mean CRP was 142.53 mg/L and 189.57 mg/L in the low- and high-risk groups, respectively, on postoperative day (POD)3. On POD2, mean PCT was 2.75 ng/mL and 8.16 ng/mL in low- and high-risk patients, respectively; values on POD3 were 3.53 ng/mL and 14.86 ng/mL, respectively. The areas under the curve (AUC) for CRP and PCT on POD3 were 0.71 and 0.78, respectively (CRP cut-off: 235.64 mg/L; sensitivity: 96%; specificity: 89.42% vs PCT cut-off: 3.94 ng/mL; sensitivity: 86%; specificity: 93.56%; AUC: 0.78). The AUC, sensitivity, and specificity for the combined diagnostic ability of CRP and PCT on POD3 were 0.92, 90%, and 100%, respectively (cut-off: 0.44). CONCLUSIONS: Combining PCT and CRP on POD3 enhances the diagnostic accuracy for AL.

Updated evidence of the effectiveness and safety of transanal drainage tube for the prevention of anastomotic leakage after rectal low anterior resection: a systematic review and meta-analysis.

BACKGROUNDS: Anastomotic leakage (AL) represents a major complication after rectal low anterior resection (LAR). Transanal drainage tube (TDT) placement offers a potential strategy for AL prevention; however, its efficacy and safety remain contentious. METHODS: A systematic review and meta-analysis were used to evaluate the influence of TDT subsequent to LAR as part of the revision of the surgical site infection prevention guidelines of the Japanese Society of Surgical Infectious Diseases (PROSPERO registration; CRD42023476655). We searched each database, and included randomized controlled trials (RCTs) and observational studies (OBSs) comparing TDT and non-TDT outcomes. The main outcome was AL. Data were independently extracted by three authors and random-effects models were implemented. RESULTS: A total of three RCTs and 18 OBSs were included. RCTs reported no significant difference in AL rate between the TDT and non-TDT groups [relative risk (RR): 0.69, 95% confidence interval (CI) 0.42-1.15]. OBSs reported that TDT reduced AL risk [odds ratio (OR): 0.45, 95% CI 0.31-0.64]. In the subgroup excluding diverting stoma (DS), TDT significantly lowered the AL rate in RCTs (RR: 0.57, 95% CI 0.33-0.99) and OBSs (OR: 0.41, 95% CI 0.27-0.62). Reoperation rates were significantly lower in the TDT without DS groups in both RCTs (RR: 0.26, 95% CI 0.07-0.94) and OBSs (OR: 0.40, 95% CI 0.24-0.66). TDT groups exhibited a higher anastomotic bleeding rate only in RCTs (RR: 4.28, 95% CI 2.14-8.54), while shorter hospital stays were observed in RCTs [standard mean difference (SMD): -0.44, 95% CI -0.65 to -0.23] and OBSs (SMD: -0.54, 95% CI -0.97 to -0.11) compared with the non-TDT group. CONCLUSIONS: A universal TDT placement cannot be recommended for all rectal LAR patients. Some patients may benefit from TDT, such as patients without DS creation. Further investigation is necessary to identify the specific beneficiaries.

C-reactive protein-to-albumin ratio as a risk factor for anastomotic leakage after anterior resection for rectal cancer with intraoperative use of indocyanine green fluorescence imaging.

INTRODUCTION: Indocyanine green fluorescence imaging (ICG-FI) reduces anastomotic leakage (AL) in rectal cancer surgery. However, no studies investigating risk factors for anastomotic leakage specific to the group using ICG-FI have ever previously been conducted. The purpose of this retrospective multicenter study was to ascertain the risk factors for AL in the group using ICG-FI. METHODS: A total of 638 patients who underwent laparoscopic or robotic anterior resection for rectal cancer between April 2018 and March 2023 were included in this study. Patients were divided into two groups: the ICG-FI group (n = 269) and the non-ICG-FI group (n = 369) for comparative analysis. The effects of clinicopathological and treatment-related factors on AL in the ICG-FI group were evaluated using both univariate and multivariate analyses. RESULTS: The incidence of AL in the ICG-FI group was 4.8%. Although there was no significant difference in the incidence of AL between the two groups, it was observed to be lower in the ICG-FI group. A multivariate analysis revealed a preoperative C-reactive protein-to-albumin ratio (CAR) ≥ 0.049 (odds ratio, 3.73; 95% confidence interval, 1.01-13.70; p = 0.048) as an independent risk factor for AL in the ICG-FI group. CONCLUSIONS: In this study, CAR was the only identified risk factor for AL in the ICG-FI group. It was suggested that CAR could be a criterion for early surgical intervention, prior to the escalation of risks, or for considering interventions such as diverting stoma creation.

Meta-analysis: loop ileostomy versus colostomy to prevent complications of anterior resection for rectal cancer.

PURPOSE: Anastomotic leakage is a serious complication of colorectal cancer surgery, prolonging hospital stays and impacting patient prognosis. Preventive colostomy is required in patients at risk of anastomotic fistulas. However, it remains unclear whether the commonly used loop colostomy(LC) or loop ileostomy(LI) can reduce the complications of colorectal surgery. This study aims to compare perioperative morbidities associated with LC and LI following anterior rectal cancer resection, including LC and LI reversal. METHODS: In this meta-analysis, the Embase, Web of Science, Scopus, PubMed, and Cochrane Library databases were searched for prospective cohort studies, retrospective cohort studies, and randomized controlled trials (RCTs) on perioperative morbidity during stoma development and reversal up to July 2023, The meta-analysis included 10 trials with 2036 individuals (2 RCTs and 8 cohorts). RESULTS: No significant differences in morbidity, mortality, or stoma-related issues were found between the LI and LC groups after anterior resection surgery. However, patients in the LC group exhibited higher rates of stoma prolapse (RR: 0.39; 95%CI: 0.19-0.82; P = 0.01), retraction (RR: 0.45; 95%CI: 0.29-0.71; P < 0.01), surgical site infection (RR: 0.52; 95%CI: 0.27-1.00; P = 0.05) and incisional hernias (RR: 0.53; 95%CI: 0.32-0.89; P = 0.02) after stoma closure compared to those in the LI group. Conversely, the LI group showed higher rates of dehydration or electrolyte imbalances(RR: 2.98; 95%CI: 1.51-5.89; P < 0.01), high-output(RR: 6.17; 95%CI: 1.24-30.64; P = 0.03), and renal insufficiency post-surgery(RR: 2.51; 95%CI: 1.01-6.27; P = 0.05). CONCLUSION: Our study strongly recommends a preventive LI for anterior resection due to rectal cancer. However, ileostomy is more likely to result in dehydration, renal insufficiency, and intestinal obstruction. More multicenter RCTs are needed to corroborate this.

SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

Quantitative analysis of intestinal perfusion with indocyanine green (ICG) and methylene blue (MB) using a single clinically approved fluorescence imaging system: a demonstration in a porcine model.

BACKGROUND: Near-infrared fluorescence (NIRF) angiography with intraoperative administration of indocyanine green (ICG) has rapidly disseminated in clinical practice. Another clinically approved, and widely available dye, methylene blue (MB), has up to now not been used for this purpose. Recently, we demonstrated promising results for the real-time evaluation of intestinal perfusion using this dye. The primary aim of this study was to perform a quantitative analysis of bowel perfusion assessment for both ICG and MB. METHODS: Four mature female Landrace pigs underwent laparotomy under general anesthesia. An ischemic bowel loop with five regions of interest (ROIs) with varying levels of perfusion was created in each animal. An intravenous (IV) injection of 0.25 mg/kg-0.50 mg/kg MB was administered after 10 min, followed by NIRF imaging in MB mode and measurement of local lactate levels in all corresponding ROIs. This procedure was repeated in ICG mode (IV dose of 0.2 mg/kg) after 60 min. The quest spectrum fluorescence camera (Quest Medical Imaging, Middenmeer, The Netherlands) was used for NIRF imaging of both MB and ICG. RESULTS: Intraoperative NIRF imaging of bowel perfusion assessment with MB and ICG was successful in all studied animals. Ingress (i/s) levels were calculated and correlated with local lactate levels. Both MB and ICG ingress values showed a significant negative correlation (r = - 0.7709; p = < 0.001; r = - 0.5367, p = 0.015, respectively) with local lactate levels. This correlation was stronger for MB compared to ICG, although ICG analysis showed higher absolute ingress values. CONCLUSION: Our fluorescence quantification analysis validates the potential to use MB for bowel perfusion assessment besides the well-known and widely used ICG. Further human studies are necessary to translate our findings to clinical applications.

Machine learning-based preoperative analytics for the prediction of anastomotic leakage in colorectal surgery: a swiss pilot study.

BACKGROUND: Anastomotic leakage (AL), a severe complication following colorectal surgery, arises from defects at the anastomosis site. This study evaluates the feasibility of predicting AL using machine learning (ML) algorithms based on preoperative data. METHODS: We retrospectively analyzed data including 21 predictors from patients undergoing colorectal surgery with bowel anastomosis at four Swiss hospitals. Several ML algorithms were applied for binary classification into AL or non-AL groups, utilizing a five-fold cross-validation strategy with a 90% training and 10% validation split. Additionally, a holdout test set from an external hospital was employed to assess the models' robustness in external validation. RESULTS: Among 1244 patients, 112 (9.0%) suffered from AL. The Random Forest model showed an AUC-ROC of 0.78 (SD: ± 0.01) on the internal test set, which significantly decreased to 0.60 (SD: ± 0.05) on the external holdout test set comprising 198 patients, including 7 (3.5%) with AL. Conversely, the Logistic Regression model demonstrated more consistent AUC-ROC values of 0.69 (SD: ± 0.01) on the internal set and 0.61 (SD: ± 0.05) on the external set. Accuracy measures for Random Forest were 0.82 (SD: ± 0.04) internally and 0.87 (SD: ± 0.08) externally, while Logistic Regression achieved accuracies of 0.81 (SD: ± 0.10) and 0.88 (SD: ± 0.15). F1 Scores for Random Forest moved from 0.58 (SD: ± 0.03) internally to 0.51 (SD: ± 0.03) externally, with Logistic Regression maintaining more stable scores of 0.53 (SD: ± 0.04) and 0.51 (SD: ± 0.02). CONCLUSION: In this pilot study, we evaluated ML-based prediction models for AL post-colorectal surgery and identified ten patient-related risk factors associated with AL. Highlighting the need for multicenter data, external validation, and larger sample sizes, our findings emphasize the potential of ML in enhancing surgical outcomes and inform future development of a web-based application for broader clinical use.

Risk factors for anastomotic leakage in colonic procedures within an ERAS-protocol. A retrospective cohort study from the Swedish part of the international ERAS-database.

BACKGROUND: Research on anastomotic leakage (AL) in colonic procedures within an Enhanced Recovery After Surgery (ERAS) protocol has not yet been conducted. The aim of this study was to identify risk factors for AL after colonic surgery. METHODS: The study included all consecutively recorded patients operated with colonic resection surgery in the Swedish part of the international ERAS® Interactive Audit System (EIAS) between September 2009 and June 2022. The cohort was analyzed and evaluated regarding risk factors for AL. RESULTS: Altogether 10,632 patients were included, 10,219 were without AL and 413 (3.9%) were with AL. After adjusted analysis, male sex (4.6% AL), OR: 1.49; 95% CI (1.16-1.90), obesity (4.8% AL), OR: 1.62; 95% CI (1.18-2.24), previous surgery (4.4% AL), OR: 1.45; 95% CI (1.14-1.86), open surgery (4.4% AL), OR: 1.36; 95% CI (1.02-1.83), anastomosis between small bowel and rectum (13.1% AL), OR: 3.97; 95% CI (2.23-7.10), stapled anastomosis (5.3% AL), OR: 2.46; 95% CI (1.79-3.38), inhalation anesthesia (4.2% AL), OR: 1.80; 95% CI (1.26-2.57), and conversion to open surgery (5.5% AL), OR 1.49; 95% CI (1.02-2.19) were significant risk factors for AL. Although pre and intraoperative compliance to the ERAS-protocol was similar, excess of fluids day 0 was an independent predictor for AL. CONCLUSION: Male sex, obesity, previous surgery, open surgery, stapled anastomotic technique, anastomosis between small bowel and rectum, inhalation anesthesia, conversion to open surgery, and among ERAS interventions, excess of fluids day 0, were significant risk factors for AL.

A real-world study was conducted to develop a nomogram that predicts the occurrence of anastomotic leakage in patients with esophageal cancer following esophagectomy.

BACKGROUND: The incidence of anastomotic leakage (AL) following esophagectomy is regarded as a noteworthy complication. There is a need for biomarkers to facilitate early diagnosis of AL in high-risk esophageal cancer (EC) patients, thereby minimizing its morbidity and mortality. We assessed the predictive abilities of inflammatory biomarkers for AL in patients after esophagectomy. METHODS: In order to ascertain the predictive efficacy of biomarkers for AL, Receiver Operating Characteristic (ROC) curves were generated. Furthermore, univariate, LASSO, and multivariate logistic regression analyses were conducted to discern the risk factors associated with AL. Based on these identified risk factors, a diagnostic nomogram model was formulated and subsequently assessed for its predictive performance. RESULTS: Among the 438 patients diagnosed with EC, a total of 25 patients encountered AL. Notably, elevated levels of interleukin-6 (IL-6), IL-10, C-reactive protein (CRP), and procalcitonin (PCT) were observed in the AL group as compared to the non-AL group, demonstrating statistical significance. Particularly, IL-6 exhibited the highest predictive capacity for early postoperative AL, exhibiting a sensitivity of 92.00% and specificity of 61.02% at a cut-off value of 132.13 pg/ml. Univariate, LASSO, and multivariate logistic regression analyses revealed that fasting blood glucose ≥7.0mmol/L and heightened levels of IL-10, IL-6, CRP, and PCT were associated with an augmented risk of AL. Consequently, a nomogram model was formulated based on the results of multivariate logistic analyses. The diagnostic nomogram model displayed a robust discriminatory ability in predicting AL, as indicated by a C-Index value of 0.940. Moreover, the decision curve analysis provided further evidence supporting the clinical utility of this diagnostic nomogram model. CONCLUSIONS: This predictive instrument can serve as a valuable resource for clinicians, empowering them to make informed clinical judgments aimed at averting the onset of AL.

Intraoperative left-sided colorectal anastomotic testing in clinical practice: a multi-treatment machine-learning analysis of the iCral3 prospective cohort.

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Remote ischemic preconditioning versus sham-control for prevention of anastomotic leakage after resection for rectal cancer (RIPAL trial): a pilot randomized controlled, triple-blinded monocenter trial.

PURPOSE: Remote ischemic preconditioning (RIPC) reportedly reduces ischemia‒reperfusion injury (IRI) in various organ systems. In addition to tension and technical factors, ischemia is a common cause of anastomotic leakage (AL) after rectal resection. The aim of this pilot study was to investigate the potentially protective effect of RIPC on anastomotic healing and to determine the effect size to facilitate the development of a subsequent confirmatory trial. MATERIALS AND METHODS: Fifty-four patients with rectal cancer (RC) who underwent anterior resection were enrolled in this prospectively registered (DRKS0001894) pilot randomized controlled triple-blinded monocenter trial at the Department of Surgery, University Medicine Mannheim, Mannheim, Germany, between 10/12/2019 and 19/06/2022. The primary endpoint was AL within 30 days after surgery. The secondary endpoints were perioperative morbidity and mortality, reintervention, hospital stay, readmission and biomarkers of ischemia‒reperfusion injury (vascular endothelial growth factor, VEGF) and cell death (high mobility group box 1 protein, HMGB1). RIPC was induced through three 10-min cycles of alternating ischemia and reperfusion to the upper extremity. RESULTS: Of the 207 patients assessed, 153 were excluded, leaving 54 patients to be randomized to the RIPC or the sham-RIPC arm (27 each per arm). The mean age was 61 years, and the majority of patients were male (37:17 (68.5:31.5%)). Most of the patients underwent surgery after neoadjuvant therapy (29/54 (53.7%)) for adenocarcinoma (52/54 (96.3%)). The primary endpoint, AL, occurred almost equally frequently in both arms (RIPC arm: 4/25 (16%), sham arm: 4/26 (15.4%), p = 1.000). The secondary outcomes were comparable except for a greater rate of reintervention in the sham arm (9 (6-12) vs. 3 (1-5), p = 0.034). The median duration of endoscopic vacuum therapy was shorter in the RIPC arm (10.5 (10-11) vs. 38 (24-39) days, p = 0.083), although the difference was not statistically significant. CONCLUSION: A clinically relevant protective effect of RIPC on anastomotic healing after rectal resection cannot be assumed on the basis of these data.