Risk Factor Targeted Perioperative Care Reduces Anastomotic Leakage after Colorectal Surgery: The DoubleCheck study.

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.

Fluid management and vasopressor use during colorectal surgery: the search for the optimal balance.

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.

Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence.

OBJECTIVE: The aim of this study was to evaluate oncological outcome for patients with and without anastomotic leakage after colon or rectal cancer surgery. SUMMARY OF BACKGROUND DATA: The role of anastomotic leakage in oncological outcome after colorectal cancer surgery is still topic of debate and impact on follow-up and consideration for further treatment remains unclear. METHODS: Patients included in the international, multicenter, non-inferior, open label, randomized, controlled trials COLOR and COLOR II, comparing laparoscopic surgery for curable colon (COLOR) and rectal (COLOR II) cancer with open surgery, were analyzed. Patients operated by abdominoperineal excision were excluded. Both univariate and multivariate analyses were performed to investigate the impact of leakage on overall survival, disease-free survival, local and distant recurrences, adjusted for possible confounders. Primary endpoints in the COLOR and COLOR II trial were disease-free survival and local recurrence at 3-year follow-up, respectively, and secondary endpoints included anastomotic leakage rate. RESULTS: For colon cancer, anastomotic leakage was not associated with increased percentage of local recurrence or decreased disease-free-survival. For rectal cancer, an increase of local recurrences (13.3% vs 4.6%; hazard ratio 2.96; 95% confidence interval 1.38-6.34; P = 0.005) and a decrease of disease-free survival (53.6% vs 70.9%; hazard ratio 1.67; 95% confidence interval 1.16-2.41; P = 0.006) at 5-year follow-up were found in patients with anastomotic leakage. CONCLUSION: Short-term morbidity, mortality, and long-term oncological outcomes are negatively influenced by the occurrence of anastomotic leakage after rectal cancer surgery. For colon cancer, no significant effect was observed; however, due to low power, no conclusions on the influence of anastomotic leakage on outcomes after colon surgery could be reached. Clinical awareness of increased risk of local recurrence after anastomotic leakage throughout the follow-up is mandatory.Trial Registration: Registered with ClinicalTrials.gov, number NCT00387842 and NCT00297791.

LekCheck: A Prospective Study to Identify Perioperative Modifiable Risk Factors for Anastomotic Leakage in Colorectal Surgery.

OBJECTIVE: To assess potentially modifiable perioperative risk factors for anastomotic leakage in adult patients undergoing colorectal surgery. SUMMARY BACKGROUND DATA: Colorectal anastomotic leakage (CAL) is the single most important denominator of postoperative outcome after colorectal surgery. To lower the risk of CAL, the current research focused on the association of potentially modifiable risk factors, both surgical and anesthesiological. METHODS: A consecutive series of adult patients undergoing colorectal surgery with primary anastomosis was enrolled from January 2016 to December 2018. Fourteen hospitals in Europe and Australia prospectively collected perioperative data by carrying out the LekCheck, a short checklist carried out in the operating theater as a time-out procedure just prior to the creation of the anastomosis to check perioperative values on 1) general condition 2) local perfusion and oxygenation, 3) contamination, and 4) surgery related factors. Univariate and multivariate logistic regression analysis were performed to identify perioperative potentially modifiable risk factors for CAL. RESULTS: There were 1562 patients included in this study. CAL was reported in 132 (8.5%) patients. Low preoperative hemoglobin (OR 5.40, P < 0.001), contamination of the operative field (OR 2.98, P < 0.001), hyperglycemia (OR 2.80, P = 0.003), duration of surgery of more than 3 hours (OR 1.86, P = 0.010), administration of vasopressors (OR 1.80, P = 0.010), inadequate timing of preoperative antibiotic prophylaxis (OR 1.62, P = 0.047), and application of epidural analgesia (OR, 1.81, P = 0. 014) were all associated with CAL. CONCLUSIONS: This study identified 7 perioperative potentially modifiable risk factors for CAL. The results enable the development of a multimodal and multidisciplinary strategy to create an optimal perioperative condition to finally lower CAL rates.

Somatostatin analogues for the prevention of pancreatic fistula after open pancreatoduodenectomy: A nationwide analysis.

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. Multivariable 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.

Short-term outcome for high-risk patients after esophagectomy.

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.

Autologous Activated Fibrin Sealant for the Esophageal Anastomosis: A Feasibility Study.

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.

[Artificial Intelligence: applications for the operating room]. / Artificiële intelligentie in de operatiekamer.

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.

Intraoperative conditions of patients undergoing pancreatoduodenectomy.

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 clinical suspicion of a leaking intrathoracic esophagogastric anastomosis: the role of CT imaging.

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.