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.

Is robotic better than laparoscopic approach for right colectomy? A cohort study from two Tuscany centers.

Robotic surgery is becoming more and more frequent. In colon surgery it can be used safely with similar results to laparoscopic surgery. The objective of our work is to retrospectively compare the short-term results (30 days) of robotic and laparoscopic right hemicolectomy. It will be helpful to understand if there are any advantages of robotic over laparoscopic surgery. METHODS: Data of miniinvasive (laparoscopic and robotic) right colectomy procedures performed from January 1, 2013 to December 31, 2019 in two Tuscany hospitals were retrospectively collected and analyzed. The mean hospital stay, complication rate, flatus pass, operative time, conversion rate and the number of removed lymph nodes, between the two methods have been compared. RESULTS: The total number of the patients that underwent right miniinvasive colectomy was 211. Sixteen patients were excluded from the study. Of the 195 included patients, 143 were operated with the robotic approach, and 52 with the laparoscopic one. There was no significant difference between the mean hospital stay (7 days in both), canalization to gas (4 days in both), anastomotic dehiscence (2 in robotic and 1 in laparoscopy), and Clavien Dindo 3 - 5 grade complications. The operation time (215 vs 175 min) and the number of retrieved lymph nodes (19 vs 15) were significantly greater in the robotic approach. CONCLUSION: The robotic approach may be advantageous in terms of surgical radicality with the price of a greater operative time. KEY WORDS: Laparoscopic, Right colectomy, Robotic.

Structured and shared CT radiological report of gastric cancer: a consensus proposal by the Italian Research Group for Gastric Cancer (GIRCG) and the Italian Society of Medical and Interventional Radiology (SIRM).

OBJECTIVES: Written radiological report remains the most important means of communication between radiologist and referring medical/surgical doctor, even though CT reports are frequently just descriptive, unclear, and unstructured. The Italian Society of Medical and Interventional Radiology (SIRM) and the Italian Research Group for Gastric Cancer (GIRCG) promoted a critical shared discussion between 10 skilled radiologists and 10 surgical oncologists, by means of multi-round consensus-building Delphi survey, to develop a structured reporting template for CT of GC patients. METHODS: Twenty-four items were organized according to the broad categories of a structured report as suggested by the European Society of Radiology (clinical referral, technique, findings, conclusion, and advice) and grouped into three "CT report sections" depending on the diagnostic phase of the radiological assessment for the oncologic patient (staging, restaging, and follow-up). RESULTS: In the final round, 23 out of 24 items obtained agreement ( ≥ 8) and consensus ( ≤ 2) and 19 out 24 items obtained a good stability (p > 0.05). CONCLUSIONS: The structured report obtained, shared by surgical and medical oncologists and radiologists, allows an appropriate, clearer, and focused CT report essential to high-quality patient care in GC, avoiding the exclusion of key radiological information useful for multidisciplinary decision-making. KEY POINTS: • Imaging represents the cornerstone for tailored treatment in GC patients. • CT-structured radiology report in GC patients is useful for multidisciplinary decision making.

Minimally Invasive Approach to Gastric GISTs: Analysis of a Multicenter Robotic and Laparoscopic Experience with Literature Review.

Background: Gastrointestinal stromal tumors (GISTs) are most frequently located in the stomach. In the setting of a multidisciplinary approach, surgery represents the best therapeutic option, consisting mainly in a wedge gastric resection. (1) Materials and methods: Between January 2010 to September 2020, 105 patients with a primary gastrointestinal stromal tumor (GISTs) located in the stomach, underwent surgery at three surgical units. (2) Results: A multi-institutional analysis of minimally invasive series including 81 cases (36 laparoscopic and 45 robotic) from 3 referral centers was performed. Males were 35 (43.2%), the average age was 66.64 years old. ASA score ≥3 was 6 (13.3%) in the RS and 4 (11.1%) in the LS and the average tumor size was 4.4 cm. Most of the procedures were wedge resections (N = 76; 93.8%) and the main operative time was 151 min in the RS and 97 min in the LS. Conversion was necessary in five cases (6.2%). (3) Conclusions: Minimal invasive approaches for gastric GISTs performed in selected patients and experienced centers are safe. A robotic approach represents a useful option, especially for GISTs that are more than 5 cm, even located in unfavorable places.

Robotic versus open oncological gastric surgery in the elderly: a propensity score-matched analysis.

Although there is no agreement on a definition of elderly, commonly an age cutoff of ≥ 65 or 75 years is used. Even if robot-assisted surgery is a validated option for the elderly population, there are no specific indications for its application in the surgical treatment of gastric cancer. The aim of this study is to evaluate the safety and feasibility of robot-assisted gastrectomy and to compare the short and long-term outcomes of robot-assisted (RG) versus open gastrectomy (OG). Patients aged ≥ 70 years old undergoing surgery for gastric cancer at the Department of Surgery of San Donato Hospital in Arezzo, between September 2012 and March 2017 were enrolled. A 1:1 propensity score matching was performed according to the following variables: age, Sex, BMI, ASA score, comorbidity, T stage and type of resection performed. 43 OG were matched to 43 RG. The mean operative time was significantly longer in the RG group (273.8 vs. 193.5 min, p < 0.01). No differences were observed in terms of intraoperative blood loss, an average number of lymph nodes removed, mean hospital stay, morbidity and mortality. OG had higher rate of major complications (6.9 vs. 16.3%, OR 2.592, 95% CI 0.623-10.785, p = 0.313) and a significantly higher postoperative pain (0.95 vs. 1.24, p = 0.042). Overall survival (p = 0.263) and disease-free survival (p = 0.474) were comparable between groups. Robotic-assisted surgery for oncological gastrectomy in elderly patients is safe and effective showing non-inferiority comparing to the open technique in terms of perioperative outcomes and overall 5-year survival.

Robot-assisted surgery in elderly and very elderly population: our experience in oncologic and general surgery with literature review.

BACKGROUND: Although there is no agreement on a definition of elderly, commonly an age cutoff of ≥65 or 75 years is used. Nowadays most of malignancies requiring surgical treatment are diagnosed in old population. Comorbidities and frailty represent well-known problems during and after surgery in elderly patients. Minimally invasive surgery offers earlier postoperative mobilization, less blood loss, lower morbidity as well as reduction in hospital stay and as such represents an interesting and validated option for elderly population. Robot-assisted surgery is a recent improvement of conventional minimally invasive surgery. AIMS: We provided a complete review of old and very old patients undergoing robot-assisted surgery for oncologic and general surgery interventions. PATIENTS AND METHODS: A retrospective review of all patients undergoing robot-assisted surgery in our General Surgery Unit from September 2012 to June 2016 was conducted. Analysis was performed for the entire cohort and in particular for three of the most performed surgeries (gastric resections, right colectomy, and liver resections) classifying patients into three age groups: ≤64, 65-79, and ≥80. Data from these three different age groups were compared and examined in respect of different outcomes: ASA score, comorbidities, oncologic outcomes, conversion rate, estimated blood loss, hospital stay, geriatric events, mortality, etc. RESULTS: Using our in-patient robotic surgery database, we retrospectively examined 363 patients, who underwent robot-assisted surgery for different diseases (402 different robotic procedures): colorectal surgery, upper GI, HPB, etc.; the oncologic procedures were 81%. Male were 56%. The mean age was 65.63 years (18-89). Patients aged ≥65 years represented 61% and ≥80 years 13%. Overall conversion rate was of 6%, most in the group 65-79 years (59% of all conversions). The more frequent diseases treated were colorectal surgery 43%, followed by hepatobilopancreatic surgery 23.4%, upper gastro-intestinal 23.2%, and others 10.4%. DISCUSSION: Robot-assisted surgery is a safe and effective technique in aging patient population too. There was no increased risk of death or morbidity compared to younger patients in the three groups examined. A higher conversion rate was observed in our experience for patients aged 65-79. Prolonged operative time and in any cases steep positions (Trendelenburg) have not represented a problem for the majority of patients. CONCLUSIONS: In any case, considering the high direct costs, minimally invasive robot-assisted surgery should be performed on a case-by-case basis, tailored to each patient with their specific histories and comorbidities.

Fast-track surgery after laparoscopic colorectal surgery: is it feasible in a general surgery unit?

BACKGROUND: The aim of the "fast-track surgery" program is to decrease the peri-operative stress response to surgical trauma and thus to a decrease in complication rates after elective surgery. Critics of fast-track (FT) rehabilitation may argue that all reports of successful programs came from major specialized hospital units and that implementation in smaller or less specialized units may be difficult if not impossible. METHODS: We retrospectively studied 101 patients who, from November 2004 to October 2007, underwent laparoscopic colorectal surgery in our institute. A detailed FT surgery protocol had been prepared and given to patients, physicians and nurses, with the aim to create a standard treatment. Data about demographics, ASA score, pre-operative complicating diseases, diagnosis, type of surgery, and postoperative clinical data were analyzed. Univariate analysis of the relationship between all factors (patient characteristics, intervention characteristics, protocol compliance and presence of complications) described here and length of hospital stay was performed. RESULTS: We compared our results to published major trials and observed no substantial differences in morbidity, mortality and length of postoperative hospital stay between the 2. Univariate analysis showed that compliance to the elements of the FT protocol influences the length of postoperative period more significantly than patient characteristics or surgical procedure. CONCLUSION: Based on 6 comparative single-center studies, the FT program was found to reduce length of hospital stay, and was deemed safe for major abdominal surgeries. Present study shows that enhanced recovery or FT program can also be implemented safely in a general surgery unit.