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

ABSTRACT: 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.

SUBMITTER: Becattini C

PROVIDER: S-EPMC9412006 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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

Becattini Cecilia C Pace Ugo U Pirozzi Felice F Donini Annibale A Avruscio Giampiero G Rondelli Fabio F Boncompagni Michela M Chiari Damiano D De Prizio Marco M Visonà Adriana A De Luca Raffaele R Guerra Francesco F Muratore Andrea A Portale Giuseppe G Milone Marco M Castagnoli Giampaolo G Righini Marc M Martellucci Jacopo J Persiani Roberto R Frasson Stefania S Dentali Francesco F Delrio Paolo P Campanini Mauro M Gussoni Gualberto G Vedovati Maria Cristina MC Agnelli Giancarlo G

Blood 20220801 8

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 rivarox ...[more]

PMID: 35580191

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Project description:ImportanceSurgery represents the mainstay treatment of colorectal liver metastases. Indications for the laparoscopic approach in this setting have been widened and there is a need to confirm the benefits of minimally invasive liver surgery (MILS) in patients with complex disease states.ObjectiveTo compare outcomes of laparoscopic surgery with those of open surgery for liver metastases from colorectal cancer, focusing on the characteristics of modern MILS and therefore overcoming possible selection bias related to different policies for patients' eligibility for MILS over time.Design, setting, and participantsA cohort study of 885 resections performed for liver metastases from colorectal cancer between January 1, 2004, and June 30, 2017, at the Hepatobiliary Surgery Unit of San Raffaele Hospital, Milano, Italy, comprising 187 laparoscopic and 698 open resections. Procedures performed using the MILS approach with a ratio of MILS to total resections per year of more than 30% were considered and were matched by propensity scores (ratio of 1:4) to procedures performed using the open approach with a ratio of MILS to total resections per year of less than 30%.Main outcomes and measuresThe primary end point was short-term outcomes, including morbidity, mortality, functional recovery, and interval between surgery and adjuvant treatments; the secondary end point was long-term outcomes.ResultsAmong this cohort (104 patients in the MILS group; 46 women and 58 men; median age, 62 years [range, 35-81 years]; and 412 patients in the open group; 181 women and 231 men; median age, 60 years [range, 37-80 years]), primary end-point data showed a significantly higher incidence of postoperative morbidity in patients who underwent open resections compared with those who underwent MILS (94 [22.8%] vs 21 [20.2%]; P = .04). Patients in the MILS group had fewer major complications (Dindo-Clavien grades III-V) compared with patients in the open group (Dindo-Clavien grades III-V; 7 [6.7%] vs 35 [8.5%]; P = .03) as well as shorter lengths of stay (median [range] duration, 3 [2-35] vs 5 [4-37] days; P = .02). Oncologic results were not compromised by the laparoscopic approach.Conclusions and relevanceIn this study, the results of the propensity score matching analysis between modern laparoscopic surgery and previous open surgery appear to confer more comparable cohorts for complexity, further supporting the advantages of laparoscopy in the surgical treatment of liver metastases from colorectal cancer. The increase in use that laparoscopy has experienced appears to be based on increased feasibility, widening of eligibility criteria for patients, enhanced clinical effectiveness, and oncologic outcomes. All these elements together suggest that up to 70% of patients appear to be candidates for this minimally invasive surgical approach in high-volume centers.

Project description:Fast-track surgery (FTS), a multimodal rehabilitation technique, has been recommended as surgical therapy for colorectal cancer. The objective of the present study was to compare the outcomes of FTS and conventional laparoscopic surgery. This study was a blinded randomized trial. A total of 70 patients with colorectal cancer were divided into two groups and underwent laparoscopic colorectal resection. The FTS group consisted of 31 patients and the control group consisted of 39 patients. Protocols for the treatment of the FTS group included skipping pre-operative mechanical bowel preparation, early restoration of diet and early post-operative ambulation. Outcome measures, length of hospital stay, post-operative surgical stress response [C-reactive protein (CRP)] and post-operative complications were compared between the two groups. The average length of total hospital stay for the FTS and the control groups was 5.9±0.8 and 10.9±1.3 days, respectively (P<0.05), and the length of post-operative hospital stay for the FTS and control group was 4.3±0.8 and 8.0±1.1 days, respectively. (P<0.05) First flatus time for the FTS and control groups was 1.6±0.8 and 2.5±0.9 days, respectively (P<0.05). Defecation time for the FTS and control groups was 2.2±0.7 and 4.5±0.7 days, respectively (P<0.05). The time to restoration of a solid diet also showed a significant difference between the FTS and control groups (1.1±0.3 vs. 3.6±0.9 days; P<0.05). Following surgery, due to post-operative surgical stress, the two groups CRP levels increased significantly, but the levels of the FTS group were lower than those of the conventional control group (P<0.05). There was no difference in post-operative complications between the FTS and control groups. This study confirms that FTS shortens hospital stay and accelerates the recovery of bowel function without increase of post-operative complications. FTS is safe, improves post-operative recovery and is a better option than conventional laparoscopic surgery for treating colorectal cancer patients.

Project description:ImportanceDespite the adoption of the optimized Enhanced Recovery After Surgery (ERAS) protocol, postoperative ileus (POI) severely impairs recovery after colorectal resection and increases the burden on the health care system.ObjectiveTo assess the efficacy of electroacupuncture (EA) in reducing the duration of POI with the ERAS protocol.Design, setting, and participantsThis multicenter, randomized, sham-controlled trial was conducted in China from October 12, 2020, through October 17, 2021. There was a 1:1 allocation using the dynamic block random method, and analyses were by intention to treat. Patients 18 years or older undergoing laparoscopic resection of colorectal cancer for the first time were randomly assigned to treatment group by a central system.InterventionsPatients were randomly assigned to 4 sessions of EA or sham electroacupuncture (SA) after surgery. All patients were treated within the ERAS protocol.Main outcomes and measuresThe primary outcome was the time to first defecation. Secondary outcomes included other patient-reported outcome measures, length of postoperative hospital stay, readmission rate within 30 days, and incidence of postoperative complications and adverse events.ResultsA total of 249 patients were randomly assigned to treatment groups. After the exclusion of 1 patient because of a diagnosis of intestinal tuberculosis, 248 patients (mean [SD] age, 60.2 [11.4] years; 153 men [61.7%]) were included in the analyses. The median (IQR) time to first defecation was 76.4 (67.6-96.8) hours in the EA group and 90.0 (73.6-100.3) hours in the SA group (mean difference, -8.76; 95% CI, -15.80 to -1.73; P = .003). In the EA group compared with the SA group, the time to first flatus (median [IQR], 44.3 [37.0-58.2] hours vs 58.9 [48.2-67.4] hours; P < .001) and the tolerability of semiliquid diet (median [IQR], 105.8 [87.0-120.3] hours vs 116.5 [92.0-137.0] hours; P = .01) and solid food (median [IQR], 181.8 [149.5-211.4] hours vs 190.3 [165.0-228.5] hours; P = .01) were significantly decreased. Prolonged POI occurred in 13 of 125 patients (10%) in the EA group vs 25 of 123 patients (20%) in the SA group (risk ratio [RR], 0.51; 95% CI, 0.27-0.95; P = .03). Other secondary outcomes were not different between groups. There were no severe adverse events.Conclusions and relevanceResults of this randomized clinical trial demonstrated that in patients undergoing laparoscopic surgery for colorectal cancer with the ERAS protocol, EA shortened the duration of POI and decreased the risk for prolonged POI compared with SA. EA may be considered as an adjunct to the ERAS protocol to promote gastrointestinal function recovery and prevent prolonged POI after surgery.Trial registrationChinese Clinical Trial Registry Identifier: ChiCTR2000038444.

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

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

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