Rivaroxaban vs placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer.

The clinical benefit of extended prophylaxis for venous thromboembolism (VTE) after laparoscopic surgery for cancer is unclear. The efficacy and safety of direct oral anticoagulants for this indication are unexplored. PROphylaxis of venous thromboembolism after LAParoscopic Surgery for colorectal cancer Study II (PROLAPS II) was a randomized, double-blind, placebo-controlled, investigator-initiated, superiority study aimed at assessing the efficacy and safety of extended prophylaxis with rivaroxaban after laparoscopic surgery for colorectal cancer. Consecutive patients who had laparoscopic surgery for colorectal cancer were randomized to receive rivaroxaban (10 mg once daily) or a placebo to be started at 7 ± 2 days after surgery and given for the subsequent 3 weeks. All patients received antithrombotic prophylaxis with low-molecular-weight heparin from surgery to randomization. The primary study outcome was the composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected deep vein thrombosis (DVT), or VTE-related death at 28 ± 2 days after surgery. The primary safety outcome was major bleeding. Patient recruitment was prematurely closed due to study drug expiry after the inclusion of 582 of the 646 planned patients. A primary study outcome event occurred in 11 of 282 patients in the placebo group compared with 3 of 287 in the rivaroxaban group (3.9 vs 1.0%; odds ratio, 0.26; 95% confidence interval [CI], 0.07-0.94; log-rank P = .032). Major bleeding occurred in none of the patients in the placebo group and 2 patients in the rivaroxaban group (incidence rate 0.7%; 95% CI, 0-1.0). Oral rivaroxaban was more effective than placebo for extended prevention of VTE after laparoscopic surgery for colorectal cancer without an increase in major bleeding. This trial was registered at www.clinicaltrials.gov as #NCT03055026.

The unwanted third wheel in the Calot's triangle: Incidence and surgical significance of caterpillar hump of right hepatic artery with a systematic review of the literature.

BACKGROUND: Caterpillar hump of the right hepatic artery is a rare variation increasing the risk of vascular and biliary injuries during hepatobiliary surgery. The aim of this study is to record the cases of the right hepatic artery forming caterpillar hump in a cohort of patients underwent laparoscopic cholecystectomy and to report a review of the literature systematically conducted. METHODS: We reviewed clinical and surgical video data of 230 patients with symptomatic cholelithiasis treated with laparoscopic cholecystectomy between January 2016 and August 2017. A systematic literature search in PubMed, Medline, Cochrane and Ovid databases until 30th June 2017 was also performed in accordance with the PRISMA statement. RESULTS: Our institutional data indicated that 1.3% of 230 patients presented caterpillar hump right hepatic artery. The systematic review included 16 studies reporting data from a total of 498 human cadavers and 579 patients submitted to cholecystectomy. The overall proportion of surgical patients with the caterpillar hump right hepatic artery was 6.9%. CONCLUSIONS: Variations of the cystic artery are not just an anatomical dissertation, assuming a very crucial role in surgical strategies to avoid uncontrolled vascular lesions. A meticulous knowledge of the hepatobiliary triangle in association with all elements of 'Culture of Safety in Cholecystectomy' is mandatory for surgeons facing more than two structures within Calot's triangle.

Oncologic Effectiveness and Safety of Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: Meta-analysis of Randomized Controlled Trials.

BACKGROUND/AIM: The role of splenectomy as an essential component of radical surgery for proximal gastric cancer, from an oncological point of view, is still debated, and no consistent recommendations have been proposed. The aim of this systematic review with meta-analysis was to provide a more robust answer regarding the oncological effectiveness and safety of splenectomy in total gastrectomy for proximal gastric carcinoma. MATERIALS AND METHODS: A systematic review and meta-analysis of randomized controlled trials was planned and performed in accordance with Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement and Cochrane Handbook for Systematic Reviews of Intervention. Patients with a histological diagnosis of gastric adenocarcinoma located in the upper third of the stomach who underwent D2 total gastrectomy with or without splenectomy were selected. The primary outcome was to analyze the influence of splenectomy on the overall survival of patients. Additionally, the mean difference in procedure time, length of hospital stay, number of retrieved lymph nodes, as well as the odds ratio of postoperative complications comparing splenectomy to spleen preservation were investigated in a secondary analysis Results: Overall, four studies with a total of 978 patients met the inclusion criteria. The pooled analysis showed no difference in overall survival rates between those who underwent spleen preservation compared to the splenectomy-treated group (risk ratio=0.92, 95% confidence interval=0.79 to 1.06, p=0.277). Interestingly, all studies reporting overall morbidity data highlighted statistically significant differences in favor of spleen-preservation group (odds ratio=2.11, 95% confidence interval=1.44 to 3.09, p<0.001). CONCLUSION: In total, gastrectomy for proximal gastric cancer, splenectomy should not be recommended as it increases operative morbidity without improving survival when compared to spleen preservation. Furthermore, our results may help in planning the updated versions of Gastric Cancer Treatment Guidelines. This meta-analysis, however, points to the urgent need for high-quality, well-designed, large-scale, clinical trials, with short-as well as long-term evaluation comparing splenectomy with spleen-preserving procedures, in a controlled randomized manner to help future research and to establish an evidence-based approach to gastric cancer treatment.

Oncologic Effectiveness and Safety of Bursectomy in Patients with Advanced Gastric Cancer: A Systematic Review and Updated Meta-Analysis.

Purpose/Aim: In the past few decades some researchers have questioned whether bursectomy for gastric cancer is essential from an oncological point of view and no consistent recommendations have been proposed. The aim of this systematic review with meta-analysis is to investigate the oncologic effectiveness and safety of bursectomy for the treatment of advanced gastric cancer patients. MATERIALS AND METHODS: We planned and performed this systematic review and meta-analysis in accordance with Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement and Cochrane Handbook for Systematic Reviews of Intervention. RESULTS: Overall, four studies with a total of 1,340 patients met inclusion criteria. The pooled hazard ratio for overall survival between the bursectomy versus nonbursectomy groups was [HR = 0.85, 95% CI 0.66-1.11, p =.252]. Interestingly, the pooled HR between the two groups in serosa-positive cases subgroup, showed a significant improvement of overall survival rate in favor of bursectomy [HR = 0.72, 95% CI 0.73-0.99, p <.05]. CONCLUSIONS: Bursectomy represents a surgical procedure that might be able to improve overall survival in serosa positive gastric cancer patients. However, a definitive conclusion could not be made because of the studies' methodological limitations. This meta-analysis points to the urgent need of high quality, large-scaled, clinical trials with short- as well as long-term evaluation comparing bursectomy with non bursectomy procedures, in a controlled randomized manner, helping future researches and establishing a modern and tailored approach to gastric cancer.