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.
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.
Transthoracic esophagectomy (TTE) for esophageal cancer facilitates mediastinal dissection; however, it has a significant impact on cardiopulmonary status. High-risk patients may therefore be better candidates for transhiatal esophagectomy (THE) in order to prevent serious complications. This study addressed short-term outcome following TTE and THE in patients that are considered to have a higher risk of surgery-related morbidity. This population-based study included patients who underwent a curative esophagectomy between 2011 and 2018, registered in the Dutch Upper GI Cancer Audit. The Charlson comorbidity index was used to assign patients to a low-risk (score <= 1) and high-risk group (score >= 2). Propensity score matching was applied to produce comparable groups between high-risk patients receiving TTE and THE. Primary endpoint was mortality (in-hospital/30-day mortality), secondary endpoints included morbidity and oncological outcomes. Additionally, a matched subgroup analysis was performed, including only cervical reconstructions. Of 5,438 patients, 945 and 431 high-risk patients underwent TTE and THE, respectively. After propensity score matching, mortality (6.3 vs 3.3%, P = 0.050), overall morbidity, Clavien-Dindo >= 3 complications, pulmonary complications, cardiac complications and re-interventions were significantly more observed after TTE compared to THE. A significantly higher mortality after TTE with a cervical reconstruction was found compared to THE (7.0 vs. 2.2%, P = 0.020). Patients with a high Charlson comorbidity index predispose for a complicated postoperative course after esophagectomy, this was more outspoken after TTE compared to THE. In daily practice, these outcomes should be balanced with the lower lymph node yield, but comparable positive node count and radicality after THE.
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.
The operating room nowadays is a data-rich environment to which Artificial Intelligence (AI) can respond. Current AI applications mainly focus on supporting perioperative decision-making and on improving surgical skills and safety. Specific steps need to be taken to advance the implementation of AI. Further studies are needed that focus on external validation and standardization of data and monitoring of the implementation process, as well as consensus on ethical and legal issues. In conclusion, much is expected from AI in making surgical care more efficient and safer.
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.
The aim of the study was to investigate the reliability and the validity of the Swedish version of the Bath Ankylosing Spondylitis Functional Index (BASFI). A total of 113 patients were assessed with the BASFI, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), and the Bath Ankylosing Spondylitis Patient Global Score (BAS-G). The median BASFI scores on two occasions within 24 hours were 3.6 versus 3.7 (p>0.05). The patients found the BASFI items relevant. The median self-reported and physiotherapist-observed BASFI scores were 3.4 and 2.8 respectively (p>0.05). The correlation coefficient between the BASFI and the BASMI was r(s)=0.55, between the BASFI and the BASDAI r(s)=0.68, and between the BASFI and the BAS-G r(s)=0.67. Significant improvements between the pre- and post-training results for both the BASFI (3.1 vs 2.0, p<0.001) and the BASMI (3.0 vs 1.0, p<0.001) were found after three weeks' inpatient rehabilitation. The results indicated that the Swedish BASFI is reliable and valid.
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 CT imaging is the primary diagnostic approach to assess the integrity of the intrathoracic anastomosis following Ivor Lewis esophagectomy. In the postoperative setting interpretation of CT findings, such as air and fluid collections, may be challenging. Establishment of a scoring system that incorporates CT findings to diagnose anastomotic leakage could assist radiologists and surgeons in the postoperative phase. Methods Consecutive patients who underwent a CT scan for a clinical suspicion of postoperative anastomotic leakage following Ivor Lewis esophagectomy between 2010 and 2016 in two medical centers were retrospectively included. Scans were excluded when oral contrast was not (correctly) administered. Acquired images were randomized and independently assessed by two experienced gastrointestinal radiologists, blinded for clinical information. For this study anastomotic leakage was defined as a visible defect during endoscopy or thoracotomy. Results A total of 80 patients had 101 CT scans, resulting in 32 scans with a confirmed anastomotic leak (25 patients). After multivariable backward stepwise logistic regression, a practical 5-point scoring system was developed, which included the following CT findings: presence of extraluminal oral contrast, air collection at the anastomotic site, fluid collection at the anastomotic site, pneumothorax and loculated pleural effusion. Patients with a score of ≥3 were considered at high risk for anastomotic leakage (positive predictive value: 83.3%), patients with scores <3 were considered at low risk for anastomotic leakage (negative predictive value: 84.4%). The scoring system showed a superior diagnostic performance compared to the original CT report and blinded interpretation of two radiologists. Conclusions Our CT-based practical scoring system enables a standardized approach in CT assessment and could facilitate early recognition of anastomotic leakage in patients after Ivor Lewis esophagectomy.
BACKGROUND:Esophageal cancer is surgically treated by means of an esophagectomy. However, esophagectomies are associated with high morbidity rates with dehiscence of the anastomosis occurring in 19% of these procedures in the Netherlands. Application of a fibrin sealant may improve mechanical strength of the anastomosis. The aim of this study was to determine the technical feasibility of the application of an autologous fibrin sealant by aerosolized spraying on esophageal anastomoses. METHODS:This study was designed as a single-center feasibility study. Patients undergoing elective minimal invasive esophageal surgery with the creation of a thoracic or a cervical anastomosis were eligible. Fibrin sealant (Vivostat) was applied to the anastomosis intraoperatively. Feasibility was measured using a nine-item checklist, designed for intraoperative application. RESULTS:In total, fifteen patients, between the ages of 43-79 y, were included in this study. One procedure scored eight out of nine points on the feasibility checklist, so application was considered as unsuccessful. The other fourteen procedures obtained a 100% score and were documented as successful procedures. Together, this led to a success rate of 93%. Grade III anastomotic leakage occurred in one of the fifteen patients (6.7%). CONCLUSIONS:This study showed that application of fibrin sealant on esophageal anastomoses is technically feasible and safe. Future studies may investigate the possible protective effects of fibrin sealant application on the development of anastomotic leakage. NCT03251040.