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Background Reducing the incidence of anastomotic leakages would benefit both patients and health care in general. Attempts to solve this problem have been disappointing thus far. Sylys® Surgical Sealant was developed as an extraluminal adjunct to standard closure techniques for bowel anastomosis procedures. We describe the results of a first-in-man study in which Sylys® Surgical Sealant is used. The aim of this study was to evaluate the safety of Sylys® Surgical Sealant in stoma reversal procedures. Methods This prospective, multicenter, non-randomized, first-in-man industry initiated study was performed in two independent hospitals in the Netherlands. The study population consisted of adults who were scheduled for an open ileostomy reversal procedure. Exclusion critera were: patients with severe co-morbidities, patients receiving antibiotics, immunosuppressive agents or steroids for pre-existing conditions. Follow up was conducted during 3 months after surgery at the outpatient clinic. Results Sixteen patients were eligible for inclusion. Twenty adverse events were recorded in 12 of the 16 treated patients (75%). None of these events were considered to be related to Sylys® Surgical Sealant. No clinical signs of anastomotic leakage were reported. Conclusions In conclusion, this first-in-man application of Sylys® Surgical Sealant as an adjunct to standard bowel anastomosis closure techniques did not show any adverse effects in relation to the sealant in 16 patients. [ABSTRACT FROM AUTHOR]

Background: Conversion and anastomotic leakage in colorectal cancer surgery have been suggested to have a negative impact on long-term oncologic outcomes. The aim of this study in a large Dutch national cohort was to analyze the influence of conversion and anastomotic leakage on long-term oncologic outcome in rectal cancer surgery., Methods: Patients were selected from a retrospective cross-sectional snapshot study. Patients with a benign lesion, distant metastasis, or unknown tumor or metastasis status were excluded. Overall (OS) and disease-free survival (DFS) were compared between laparoscopic, converted, and open surgery as well as between patients with and without anastomotic leakage., Results: Out of a database of 2095 patients, 638 patients were eligible for inclusion in the laparoscopic, 752 in the open, and 107 in the conversion group. A total of 746 patients met the inclusion criteria and underwent low anterior resection with primary anastomosis, including 106 (14.2%) with anastomotic leakage. OS and DFS were significantly shorter in the conversion compared to the laparoscopic group (p = 0.025 and p = 0.001, respectively) as well as in anastomotic leakage compared to patients without anastomotic leakage (p = 0.002 and p = 0.024, respectively). In multivariable analysis, anastomotic leakage was an independent predictor of OS (hazard ratio 2.167, 95% confidence interval 1.322-3.551) and DFS (1.592, 1077-2.353). Conversion was an independent predictor of DFS (1.525, 1.071-2.172), but not of OS., Conclusion: Technical difficulties during laparoscopic rectal cancer surgery, as reflected by conversion, as well as anastomotic leakage have a negative prognostic impact, underlining the need to improve both aspects in rectal cancer surgery.

Background: Anastomotic leakage following colorectal surgery still occurs all too frequently, and this complication is difficult to predict. A nonfunctional stoma may reduce the risk of clinically relevant leaks but is overtreatment for most patients. More accurate assessments of the risk of anastomotic leakage would be very helpful in tailoring treatment in colorectal surgery. Therefore, a Colon Leakage Score (CLS) was developed and tested. Material and Methods: The CLS was developed based on information from the literature and expert opinions. It was tested in a retrospective cohort of consecutive patients undergoing left-sided colorectal surgery with primary anastomosis in a teaching hospital in The Netherlands. Results: In the test cohort, 10 of 121 patients who were not treated with a nonfunctional stoma experienced anastomotic leakage. The mean CLS in the leakage group was 16 versus eight in the group that did not have a leak (P < 0.01). Using receiver-operating characteristics, the area under the curve (AUC) showed that the CLS was a good predictor (AUC = 0.95, CI 0.89–1.00) of anastomotic leakage. Furthermore, logistic regression analysis with CLS as a predictor for anastomotic leakage showed an odds ratio of 1.74 (95% CI 1.32–2.28, P < 0.01). Conclusions: The CLS can predict the risk of anastomotic leakage following left-sided colorectal surgery. After further validation, this score may help the surgeon make a more individualized, safer decision regarding whether to perform an anastomosis or make a (nonfunctional) stoma. [ABSTRACT FROM AUTHOR]