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Objective: To assess the role of registries in the postmarketing surveillance of surgical meshes., Background: To date, surgical meshes are classified as group II medical devices. Class II devices do not require premarket clearance by clinical studies. Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries-Herniamed German Registry and Danish Hernia Database. This paper now presents the relevant data from the Herniamed Registry., Methods: The present analysis compares the prospective perioperative and 1-year follow-up data collected for all patients with incisional hernia who had undergone elective laparoscopic intraperitoneal onlay mesh repair either with Physiomesh (n = 1380) or with other meshes recommended in the guidelines (n = 3834)., Results: Patients with Physiomesh repair had a markedly higher recurrence rate compared with the other recommended meshes (12.0% vs 5.0%; P < 0.001). In the multivariable analysis, the recurrence rate was highly significantly influenced by the mesh type used (P < 0.001). If Physiomesh was used, that led to a highly significant increase in the recurrence rate on 1-year follow-up (odds ratio 2.570, 95% CI 2.057, 3.210). The mesh type used also had a significant influence on chronic pain rates., Conclusions: The importance of real-world data for postmarketing surveillance of surgical meshes has been demonstrated in this registry-based study. Randomized controlled trials are needed for premarket approval of new devices. The role of sponsorship of device studies by the manufacturing company must be taken into account.

Background: A considerable number of patients undergoing incisional hernia repair are on anticoagulant or antiplatelet therapy or have existing coagulopathy which may put them at higher risk for postoperative bleeding complications. Data about the optimal treatment of these patients are sparse. This analysis attempts to determine the rate of postoperative bleeding complications following incisional hernia repair and the consecutive rate of reoperation among patients with coagulopathy or receiving antiplatelet and anticoagulant therapy (higher risk group) compared to patients who do not have a higher risk (normal risk group)., Methods: Out of the 43,101 patients documented in the Herniamed Registry who had an incisional hernia repair, 6668 (15.5%) were on anticoagulant or antithrombotic therapy or had existing coagulopathy. The implication of that higher risk profile for onset of postoperative bleeding was investigated in multivariable analysis. Hence, other influential variables were identified., Results: The rate of postoperative bleeding in the higher risk group was 3.9% (n = 261) and significantly higher compared to the normal risk group at 1.6% (n = 564) (OR 2.001 [1.699; 2.356]; p < 0.001). Additionally, male gender, use of drains, larger defect size, open incisional hernia repair, lower BMI, and higher ASA score significantly increased the risk of postoperative bleeding. The rate of reoperations due to postoperative bleeding was significantly increased in the higher risk group compared to the normal risk group (2.4 vs. 1.0%; OR 1.217 [1.071; 1.382]; p = 0.003). Likewise, the postoperative general complication rate (6.04 vs. 3.66%; p < 0.001) as well as the mortality rate (0.46 vs. 0.17%; p < 0.001) were significantly higher in the higher risk group., Conclusions: Patients with anticoagulant or antiplatelet therapy or existing coagulopathy who undergo incisional hernia repair have a significantly higher risk for onset of postoperative bleeding. The risk of bleeding complications and complication-related reoperations seems to be lower after laparoscopic intraperitoneal onlay mesh.

Background: Laparoscopic sleeve gastrectomy (SG) is an upcoming procedure in bariatric surgery and is currently performed worldwide. Staple line leakage, as the most frequent and most feared complication, is still a major concern., Methods: Since 2005 data from patients undergoing bariatric procedures in Germany have been prospectively registered in an online database and analyzed. All patients who had undergone primary SG within a 7-year period were considered for analysis., Results: Using the German Bariatric Surgery Registry, data from more than 11,800 SGs were collected between January 1, 2005, and December 31, 2013. Staple line leak rate decreased from 6.5% to 1.4%. Male sex, higher body mass index, concomitant sleep apnea, conversion to laparotomy, longer operation time, a combination of buttresses and oversewing, and the occurrence of intraoperative complications were associated with a significantly higher leakage rate compared with when using either buttresses or oversewing alone. On multivariable analysis, operation time and year of procedure only had a significant impact on staple line leakage rate., Conclusions: Owing to the growing experience a constant decrease in the leakage rate after SG has been observed. Staple line disruption may still lead to sepsis, multiorgan dysfunction, and increased mortality. The results of the current study demonstrated that there are factors that increase the risk of leakage and which would enable surgeons to define risk groups, select patients more carefully, and offer closer follow-up during the postoperative course with early recognition and adequate treatment.

The risks and benefits of surgery for colorectal cancer in old patients have not been unequivocally defined. The present investigation was carried out in 309 hospitals as a prospective multicenter study. In the period between 1 January 2000 and 31 December 2001, a total of 19,080 patients were recruited for the study; 16,142 (84.6%) patients were younger than 80 years (<80) and 2932 (15.4%) were 80 years and older (> or =80). Significant differences between the age groups were observed for general postoperative complications (22.3% for <80 years; 33.9% for > or =80). Specific postoperative complications were identical in both groups. Overall, significantly elevated morbidity and mortality rates were found with increasing age (morbidity: 33.9% vs. 43.5%; mortality: 2.6% vs. 8.0%). The distribution of tumor stages revealed a significantly higher percentage of locally advanced tumors in the older age group (stage II: 28.0% vs. 34.4%). In contrast, no increase in metastasizing tumors was found in the older age group (stage IV: 17.4% vs. 14.1%). Logistic regression showed that, in concert with a number of other parameters, age is a significant influencing factor on postoperative morbidity and mortality. The increase in postoperative morbidity and mortality rates associated with aging is a result of the increase in general postoperative complications, in particular, pneumonia and cardiovascular complications. Age as such does not represent a contraindication for surgical treatment. The short-term outcome and quality of life are of overriding importance for the geriatric patient.