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.
1 December 2016 in International Journal of Surgery
Pilonidal disease is a quite common chronic inflammatory disease that causes discomfort, embarrassment and absence from work or school. In line with its acquired pathogenesis, a number of surgical alternatives to conventional en bloc excision have been proposed over the last decades, yielding encouraging results. We reviewed our experience with minimally invasive sinusectomy to evaluate its safety and efficacy. this study was a review of a prospectively maintained database of consecutive patients over a 7-year period. From November 2009 to December 2015, 2347 patients with pilonidal disease were operated on using the Gips procedure. Patients received surgery as a day-case procedure under local anesthesia. Operative and perioperative data were examined. there were 1714 men (73%) and 633 women (27%) in the study; the median age was 19 years. Recurrent diseases in patients who had previously undergone surgery elsewhere composed 61% of cases. Globally, 102 cases of clinically relevant postoperative complication occurred (4.3%). At a median follow up of 16 months, the recurrence rate was 5.8%. The treatment of recurrent disease did not correlate to increased recurrence rate following sinusectomy. Recurrent patients were more likely to be male and have delayed wound healing. the Gips procedure for the treatment of pilonidal disease is safe and feasible. It has a low complication and recurrence rate, early return to daily activities and offers a good cosmetic result.
Background: Anastomotic leakage is one of the most feared complications of rectal resections. The role of drains in limiting this occurrence or facilitating its early recognition is still poorly defined. We aimed to study whether the presence of prophylactic pelvic drains affects the surgical outcomes of patients undergoing rectal surgery with extraperitoneal anastomosis. Methods: PubMed, EMBASE, and the Cochrane Library were systematically searched for randomized controlled trials comparing drained with undrained anastomoses following rectal surgery. We evaluated possible differences on the relative incidences of anastomotic leakage, pelvic collection or sepsis, bowel obstruction, reoperation rate, and overall mortality. A meta-analysis of relevant studies was performed with RevMan 5.3. Results: A total of 760 patients from 4 randomized controlled studies were considered eligible for data extraction. The use of drains did not show any advantage in terms of anastomotic leak (OR 0.99), pelvic complications (OR 0.87), reintervention (OR 0.84) and mortality. Contrariwise, the incidence of postoperative bowel obstruction was significantly higher in the drained group (OR 1.61). Conclusions: The routine utilization of pelvic drains does not confer any significant advantage in the prevention of postoperative complications after rectal surgery with extraperitoneal anastomosis. Moreover, a higher risk of postoperative bowel obstruction can be of concern.
Purpose: A new robotic surgery tool allows intraoperative ultrasound to be performed using a fully robotic technique. Herein, we evaluate the feasibility and reliability of robotically integrated ultrasound to guide resection of malignant hepatic tumors. Material and methods: A consecutive series of ultrasound-guided robotic resections of primary and secondary hepatic malignancies was analyzed in terms of perioperative data and specimen evaluation, focusing on the reliability of the new robot-integrated ultrasound probe. Results: Ten consecutive patients underwent 15 robotic liver resections. Two patients were resected to excise primary hepatocellular cancers and eight underwent resections of liver metastases. R0 resections were achieved for all lesions. The median operative time was 247 min, and blood loss was limited. No mortality occurred. Conclusions: Our present analysis confirmed the reliability of fully robotic liver resection guided via robotically integrated ultrasonic assessment. Robotic surgery, particularly hepatic resection, may benefit greatly from better manageability, and the fact that the surgeon can directly manage both the operative and the diagnostic parts of the procedure.