Preoperative anemia is an important target in preventing colorectal anastomotic leakage (CAL). However, it is not consistently detected and corrected in patients undergoing colorectal surgery. This study aimed to evaluate the impact of early detection and correction of preoperative anemia on perioperative outcomes and CAL. This was a prospective subanalysis of an international open-labeled trial, which implemented an enhanced care bundle to prevent CAL after elective colorectal surgeries. It introduced interventions for early detection and correction of preoperative anemia. Primary outcome was the incidence of preoperative anemia and the effect of early correction. Secondary outcomes included the impact on CAL, postoperative course, and mortality. The study included 899 patients across eight European hospitals (September 2021–December 2023). Preoperative anemia was identified in 35.0
Objective: The DoubleCheck study aimed to introduce pre- and perioperative interventions minimizing exposure to modifiable risk factors and determine its effect on CAL. Summary Background Data: Colorectal anastomotic leakage (CAL) is a severe complication. In order to predict and prevent its occurrence, the LekCheck study identified intraoperative modifiable risk factors for CAL: anemia, hyperglycemia, hypothermia, incorrect timing of antibiotic prophylaxis, administration of vasopressors and epidural analgesia. Methods: This international open-labelled interventional study was performed between September 2021 and December 2023. An enhanced care bundle consisting of anemia correction, glucose measurement, attaining normothermia, antibiotics administration within 60 to 15 minutes preoperatively, refraining from vasopressors and epidural analgesia was introduced. Primary outcome was the occurrence of intraoperative risk factors just prior to the anastomosis creation. Secondary outcomes were CAL and mortality. Univariate and multivariate regression analysis were performed to establish the relationship between the enhanced care bundle, exposure to the six factors and CAL. Results: The historical LekCheck group consisted of 1572 patients versus 902 in the DoubleCheck. The LekCheck group had a mean of 1.84 risk factors versus 1.63 in DoubleCheck (P<0.001). In the DoubleCheck significantly less patients had ≥3 risk factors (P<0.001). CAL was significantly lower in the DoubleCheck group (8.6% vs. 6.2%, P=0.039). The reduction of CAL was associated with the enhanced care bundle in multivariate regression analysis (OR 1.521, 95% CI 1.01-2.29, P=0.045). The mortality rate did not differ significantly (1.3%, vs. 0.8%, P=0.237). Conclusions: The DoubleCheck study showed that optimization of modifiable risk factors reduced CAL in colorectal surgery.
Objective:. The primary objective of this study was to develop a length of stay (LOS) prediction model. Background:. Predicting the LOS is crucial for patient care, planning, managing expectations, and optimizing hospital resources. Prolonged LOS after colorectal surgery is largely influenced by complications, and an accurate prediction model could significantly benefit patient outcomes and healthcare efficiency. Methods:. This study included patients who underwent colorectal surgery in 14 different hospitals between January 2016 and December 2020. Two distinct random forest models were developed: one solely based on preoperative variables (preoperative prediction model [PP model]) and the other incorporating both preoperative and intraoperative variables (intraoperative prediction model [IP model]). Both models underwent validation using 10-fold cross-validation. The discriminative power of the model was assessed using the area under the curve (AUC), and calibration was evaluated using a calibration curve. The 2 developed models were compared using DeLong test. Results:. A total of 2140 patients were included in the analysis. After internal validation, the PP model achieved an AUC of 0.75 (95% confidence interval [CI]: 0.73–0.77), and the IP model achieved an AUC of 0.84 (95% CI: 0.82–0.85). The difference in discrimination between the 2 models was statistically significant (DeLong test, P < 0.001). Both models exhibited good calibration. Conclusions:. Incorporating intraoperative parameters enhances the accuracy of the predictive model for LOS after colorectal surgery. Improving LOS prediction can assist in managing the increasing number of patients and optimizing the allocation of healthcare resources.
Background: Colorectal anastomotic leakage (CAL) remains a severe complication after bowel surgery. Recent research has identified several modifiable perioperative CAL risk factors. The aim of this study is to implement an enhanced perioperative care protocol, to optimize the intraoperative condition of the patient and minimalize exposure to modifiable CAL risk factors. Secondly, this study will investigate whether implementation of this new protocol results in a decreased CAL rate. Methods: The DOUBLE CHECK study will be performed using an open-label, international, multicenter design in 11 participating hospitals. The aim is to include an intervention group of 943 adult patients that underwent a colorectal resection with creation of a primary anastomosis. The patients in the intervention group will be treated according to an enhanced perioperative care protocol focusing on optimizing the intraoperative condition of the patient by minimalizing exposure to the following perioperative factors: anemia, hyperglycemia, hypothermia, epidural anesthesia, vasopressor drug administration, and incorrect or lack of antibiotic prophylaxis. The control group will consist of 1562 historical patients that were treated with standard perioperative practice (LekCheck study cohort). The patient’s intraoperative condition defined by exposure to the six perioperative risk factors, compliance to the DOUBLE CHECK study protocol, 30-day and 90-day CAL and other postoperative complications, length of hospital-stay, and ICU stay, hospital readmission and 30-day mortality will be measured. Discussion: The strength of this study is that it is an implementation study of an enhanced perioperative practice protocol for patients that are scheduled for colorectal resection in combination with a comparative study. This protocol could be a tool for other hospitals that want to improve their perioperative care pathway.
Background Although it is known that excessive intraoperative fluid and vasopressor agents are detrimental for anastomotic healing, optimal anesthesiology protocols for colorectal surgery are currently lacking. Objective To scrutinize the current hemodynamic practice and vasopressor use and their relation to colorectal anastomotic leakage. Design A secondary analysis of a previously published prospective observational study: the LekCheck study. Study setting Adult patients undergoing a colorectal resection with the creation of a primary anastomosis. Outcome measures Colorectal anastomotic leakage (CAL) within 30 days postoperatively, hospital length of stay and 30-day mortality. Results Of the 1548 patients, 579 (37%) received vasopressor agents during surgery. Of these, 201 were treated with solely noradrenaline, 349 were treated with phenylephrine, and 29 received ephedrine. CAL rate significantly differed between the patients receiving vasopressor agents during surgery compared to patients without (11.8% vs 6.3%, p < 0.001). CAL was significantly higher in the group receiving phenylephrine compared to noradrenaline (14.3% vs 6%, p < 0.001). Vasopressor agents were used more often in patients treated with Goal Directed Therapy (47% vs 34.6%, p < 0.001). There was a higher mortality rate in patients with vasopressors compared to the group without (2.8% vs 0.4%, p = 0.01, OR 3.8). Mortality was higher in the noradrenaline group compared to the phenylephrine and those without vasopressors (5% vs. 0.4% and 1.7%, respectively, p < 0.001). In multivariable analysis, patients with intraoperative vasopressor agents had an increased risk to develop CAL (OR 2.1, CI 1.3–3.2, p = 0.001). Conclusion The present study contributes to the evidence that intraoperative use of vasopressor agents is associated with a higher rate of CAL. This study helps to create awareness on the (necessity to) use of vasopressor agents in colorectal surgery patients in striving for successful anastomotic wound healing. Future research will be required to balance vasopressor agent dosage in view of colorectal anastomotic leakage.
Background: Somatostatin analogues (SA) are currently used to prevent postoperative pancreatic fistula (POPF) development. However, its use is controversial. This study investigated the effect of different SA protocols on the incidence of POPF after pancreatoduodenectomy in a nationwide population. Methods: All patients undergoing elective open pancreatoduodenectomy were included from the Dutch Pancreatic Cancer Audit (2014-2017). Patients were divided into six groups: no SA, octreotide, lanreotide, pasireotide, octreotide only in high-risk (HR) patients and lanreotide only in HR patients. Primary endpoint was POPF grade B/C. The updated alternative Fistula Risk Score was used to compare POPF rates across various risk scenarios. Results: 1992 patients were included. Overall POPF rate was 13.1%. Lanreotide (10.0%), octreotide-HR (9.4%) and no protocol (12.7%) POPF rates were lower compared to the other protocols (varying from 15.1 to 19.1%, p = 0.001) in crude analysis. Sub-analysis in patients with HR of POPF showed a significantly lower rate of POPF when treated with lanreotide (10.0%) compared to no protocol, octreotide and pasireotide protocol (21.6-26.9%, p = 0.006). Octreotide-HR and lanreotide-HR protocol POPF rates were comparable to lanreotide protocol, however not significantly different from the other protocols. Multi-variable regression analysis demonstrated lanreotide protocol to be positively associated with a low odds-ratio (OR) for POPF (OR 0.387, 95% CI 0.180-0.834, p = 0.015). In-hospital mortality rates were not affected. Conclusion: Use of lanreotide in all patients undergoing pancreatoduodenectomy has a potential protective effect on POPF development. Protocols for HR patients only might be favorable too. However, future studies are warranted to confirm these findings. (C) 2022 The Authors. Published by Elsevier B.V. on behalf of IAP and EPC.
Background: Postoperative pancreatic fistula (POPF) is a severe complication following pancreatoduodenectomy (PD). Previous research in colorectal surgery demonstrated suboptimal intraoperative conditions to be related with an increased risk of anastomotic leakage. Aim of this study was to evaluate the intraoperative condition of patients undergoing PD by both assessing whether these known intraoperative modifiable risk factors in colorectal surgery are also present during PD and by measuring compliance to intraoperative ERAS guidelines. Secondly, to determine the relation of these factors with POPF. Materials and methods: This prospective single center study included patients undergoing PD from 2016 to 2020. Parameters regarding the patient's general condition, local perfusion, oxygenation, surgical factors and ERAS elements were measured with a checklist intraoperatively, before the creation of the pancreatojejunal anastomosis. Uni- and multivariable logistic regression analyses were performed. Results: 83 patients were included. POPF occurred in 27.7% (9.0% grade B, 10.0% grade C). Patients with POPF significantly had more other postoperative complications compared to patients without POPF (100% vs. 76.2%, p = 0.017). A suboptimal intraoperative condition was observed in 89.2%. Overall compliance to the intraoperative ERAS guideline was 0%. In univariable analysis, soft pancreatic tissue, pancreatic duct <3 mm, tumor location and intraoperative vasopressor administration were significantly associated with POPF. In multivariable analysis, only soft pancreatic tissue was independently associated with POPF (OR 13.627; 95% CI 1.656-112.157, p = 0.015). Conclusion: Awareness amongst surgeons and anesthesiologists should be created. The influence of these intraoperative factors on POPF should be further evaluated in future, larger studies.
Purpose Anastomotic leakage (AL) is a dreaded complication after colorectal surgery. Preoperatively identifying high-risk patients can help to reduce the incidence of this complication. For this reason, AL risk nomograms have been developed. The objective of this study was to test the AL risk nomogram developed by Frasson, et al. for validity and to identify risk-factors for AL. Methods From the international multi-center LekCheck study database, patients who underwent colonic surgery with the formation of an anastomosis were included. Data were prospectively collected between 2016 and 2019 at 14 hospitals. Univariate and multivariable regression analyses, and area under receiver operating characteristic curve analysis (AUROC) were performed. Results A total of 643 patients were included. The median age was 70 years and 51% were male. The majority underwent surgery for malignancies (80.7%). The overall AL rate was 9.2%. The risk nomogram was not predictive for AL in the population tested (AUROC 0.572). Low preoperative haemoglobin ( p = 0.006), intraoperative hypothermia ( p = 0.02), contamination of the operative field ( p = 0.004), and use of epidural analgesia ( p = 0.02) were independent risk-factors for AL. Conclusion The AL risk nomogram could not be validated using the international LekCheck study database. In the future, intraoperative predictive factors for AL, as identified in this study, should also be included in AL risk predictors.
Perioperative hyperglycemia is a known risk factor for postoperative complications after colorectal surgery. The aim of this study was to investigate whether intraoperative blood glucose values are associated with colorectal anastomotic leakage in diabetic and non-diabetic patients undergoing colorectal surgery. This is an additional analysis of a previously published prospective, observational cohort study (the LekCheck study). Fourteen hospitals in Europe and Australia collected perioperative data. Consecutive adult patients undergoing colorectal surgery with primary anastomosis between 2016 and 2018 were included. From all patients, preoperative diabetic status was known and intraoperative blood glucose was determined just prior to the creation of the anastomosis. The primary outcome was the occurrence of anastomotic leakage within 30 days postoperatively. Of 1474 patients (mean age 68 years), 224 patients (15%) had diabetes mellitus, 737 patients (50%) had intraoperative hyperglycemia (≥126 mg/dL, ≥7.0 mmol/L), and 129 patients (8.8%) developed anastomotic leakage. Patients with intraoperative hyperglycemia had higher anastomotic leakage rates compared to patients with a normal blood glucose level (12% versus 5%, P<0.001). Anastomotic leakage rate did not significantly differ between diabetic and non-diabetic patients (12% versus 8%, P=0.058). Logistic regression analyses showed that higher blood glucose levels were associated with an increasing leakage risk in non-diabetic patients only. Incidence and severity of intraoperative hyperglycemia are associated with anastomotic leakage in non-diabetic patients. Whether hyperglycemia is an epiphenomenon, a marker for other risk factors or a potential modifiable risk factor per se for anastomotic leakage requires future research.
Purpose: Peritoneal metastases confer the worst survival in patients with metastatic colorectal cancer.Current management options are limited; with treatment resistance and disease progression common.The development of organoids as a pre-clinical disease model has raised the possibility of performing throughput drug screening to evaluate tumour sensitivities to drugs.In this multi-centre, prospective exploratory study, we aim to evaluate the feasibility of a novel organoid based platform to integrate genomic and functional drug sensitivities to deliver personalized therapy to patients with treatment refractory CRPM Methodology: Tumour biopsies from patients undergoing surgical intervention for CRPM were used to grow organoids.Organoids were validated before undergoing throughput drug testing against over 50 FDA approved drugs Results: Organoids were found to share over 90% genomic concordance with native tumour tissue.Against FOLFOX and FOLFIRI combination regimens, organoid drug sensitivity in-vitro largely mirrored patient responses to the same drug in-vivo, confirming the validity of this organoid-based platform.Additionally, organoid drug responses were concordant with genomic driven biomarkers.Most importantly, novel therapies were detected in many patients with treatment refractory CRPM, when no genomic driven biomarkers were present, underscoring the value of functional drug testing in providing newer treatment options for patients in this otherwise poor prognostic cohort.Conclusions: An organoid based personalized medicine platform is feasible with promising early results.A phase II clinical trial is in the process of being established to further evaluate the feasibility of this platform in a clinically timely manner.
Background: Esophageal anastomotic leakage (EAL) is a severe complication following gastric and esophageal surgery for cancer. Several non-modifiable, patient or surgery related risk factors for EAL have been identified, however, the contribution of modifiable intraoperative parameters remains undetermined. This review provides an overview of current literature on potentially modifiable intraoperative risk factors for EAL. Materials and methods: The PubMed, EMBASE and Cochrane databases were searched by two researchers independently. Clinical studies published in English between 1970 and January 2017 that evaluated the effect of intraoperative parameters on the development of EAL were included. Levels of evidence as defined by the Centre of Evidence Based Medicine (CEBM) were assigned to the studies. Results: A total of 25 articles were included in the final analysis. These articles show evidence that anemia, increased amount of blood loss, low pH and high pCO2 values, prolonged duration of procedure and lack of surgical experience independently increase the risk of EAL. Supplemental oxygen therapy, epidural analgesia and selective digestive decontamination seem to have a beneficial effect. Potential risk factors include blood pressure, requirement of blood products, vasopressor use and glucocorticoid administration, however the results are ambiguous. Conclusion: Apart from fixed surgical and patient related factors, several intraoperative factors that can be modified in clinical practice can influence the risk of developing EAL. More prospective, observational studies are necessary focusing on modifiable intraoperative parameters to assess more evidence and to elucidate optimal values of these factors.
Background: Colorectal anastomotic leakage (CAL) is a major surgical complication in intestinal surgery. Despite many optimizations in patient care, the incidence of CAL is stable (3-19%) [1]. Previous research mainly focused on determining patient and surgery related risk factors. Intraoperative non-surgery related risk factors for anastomotic healing also contribute to surgical outcome. This review offers an overview of potential modifiable risk factors that may play a role during the operation.Methods: Two independent literature searches were performed using EMBASE, Pubmed and Cochrane databases. Both clinical and experimental studies published in English from 1985 to August 2015 were included. The main outcome measure was the risk of anastomotic leakage and other postoperative complications during colorectal surgery. Determined risk factors of CAL were stated as strong evidence (level I and II high quality studies), and potential risk factors as either moderate evidence (experimental studies level III), or weak evidence (level IV or V studies).Results: The final analysis included 117 articles. Independent factors of CAL are diabetes mellitus, hyperglycemia and a high HbA1c, anemia, blood loss, blood transfusions, prolonged operating time, intraoperative events and contamination and a lack of antibiotics. Unequivocal are data on blood pressure, the use of inotropes/vasopressors, oxygen suppletion, type of analgesia and goal directed fluid therapy. No studies could be found identifying the impact of body core temperature or mean arterial pressure on CAL. Subjective factors such as the surgeons' own assessment of local perfusion and visibility of the operating field have not been the subject of relevant studies for occurrence in patients with CAL.Conclusion: Both surgery related and non-surgery related risk factors that can be modified must be identified to improve colorectal care. Surgeons and anesthesiologists should cooperate on these items in their continuous effort to reduce the number of CAL. A registration study determining individual intraoperative risk factors of CAL is currently performed as a multicenter cohort study in the Netherlands. (C) 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.