Bladder Outlet Obstruction Relief and Symptom Improvement Following Medical and Surgical Therapies for Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: A Systematic Review.

BACKGROUND AND OBJECTIVE: Symptomatic benefit and urodynamic obstruction relief represent relevant outcomes of therapies for lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). We summarized evidence from studies concurrently assessing variations in terms of symptoms severity and invasive urodynamic measures of obstruction following medical and surgical therapies for LUTS/BPH. METHODS: We performed a systematic review of PubMed, Scopus, and Web of Science in June 2023. KEY FINDINGS AND LIMITATIONS: We identified 29 publications: 14 (872 patients) and 15 (851 patients) studies addressing medical and surgical therapies, respectively. The mean percentage total International Prostate Symptom Score (IPSS) improvements ranged from -2.5% to 56.3% and from 35.1% to 82.1% following medical and surgical therapies, respectively. The corresponding mean percentage Bladder Outlet Obstruction Index (BOOI) improvements ranged from 7.8% to 53.5% and from 22.4% to 138.6%, respectively. Holmium laser enucleation of the prostate (HoLEP) provided IPSS improvements in the higher range and the greatest BOOI reduction. CONCLUSIONS AND CLINICAL IMPLICATIONS: Globally, based on available evidence, more pronounced symptomatic benefits are observed following treatments providing greater deobstructive effect. In detail, patients undergoing surgery exhibit greater IPSS and BOOI improvements than those receiving medical therapy. PATIENT SUMMARY: Treatments for lower urinary tract symptoms suggestive of benign prostatic hyperplasia providing greater urodynamic improvements also provide greater symptomatic benefit. Surgical procedures provide greater symptomatic and urodynamic outcomes than medical therapies. Maximal obstruction relief, together with symptomatic benefits in the higher ranges, is observed following holmium laser enucleation of the prostate.

Timing of Major Postoperative Bleeding Among Patients Undergoing Surgery.

Importance: Although major bleeding is among the most common and prognostically important perioperative complications, the relative timing of bleeding events is not well established. This information is critical for preventing bleeding complications and for informing the timing of pharmacologic thromboprophylaxis. Objective: To determine the timing of postoperative bleeding among patients undergoing surgery for up to 30 days after surgery. Design, Setting, and Participants: This is a secondary analysis of a prospective cohort study. Patients aged 45 years or older who underwent inpatient noncardiac surgery were recruited in 14 countries between 2007 and 2013, with follow-up until December 2014. Data analysis was performed from June to July 2023. Exposure: Noncardiac surgery requiring overnight hospital admission. Main Outcomes and Measures: The primary outcome (postoperative major bleeding) was a composite of the timing of the following bleeding outcomes: (1) bleeding leading to transfusion, (2) bleeding leading to a postoperative hemoglobin level less than 7 g/dL, (3) bleeding leading to death, and (4) bleeding associated with reintervention. Each of the components of the composite primary outcome (1-4) and bleeding independently associated with mortality after noncardiac surgery, which was defined as a composite of outcomes 1 to 3, were secondary outcomes. Results: Among 39 813 patients (median [IQR] age, 63.0 [54.8-72.5] years; 19 793 women [49.7%]), there were 5340 major bleeding events (primary outcome) in 4638 patients (11.6%) within the first 30 days after surgery. Of these events, 42.7% (95% CI, 40.9%-44.6%) occurred within 24 hours after surgery, 77.7% (95% CI, 75.8%-79.5%) by postoperative day 7, 88.3% (95% CI, 86.5%-90.2%) by postoperative day 14, and 94.6% (95% CI, 92.7%-96.5%) by postoperative day 21. Within 48 hours of surgery, 56.2% of major bleeding events, 56.2% of bleeding leading to transfusion, 56.1% of bleeding independently associated with mortality after noncardiac surgery, 51.8% of bleeding associated with hemoglobin less than 7 g/dL, and 51.8% of bleeding associated with reintervention had occurred. Conclusions and Relevance: In this cohort study, of the major postoperative bleeding events in the first 30 days, more than three-quarters occurred during the first postoperative week. These findings are useful for researchers for the planning future clinical research and for clinicians in prevention of bleeding-related surgical complications and in decision-making regarding starting of pharmacologic thromboprophylaxis after surgery.

Risk of thrombosis and bleeding in gynecologic noncancer surgery: systematic review and meta-analysis.

OBJECTIVE: This study aimed to provide procedure-specific estimates of the risk for symptomatic venous thromboembolism and major bleeding in noncancer gynecologic surgeries. DATA SOURCES: We conducted comprehensive searches on Embase, MEDLINE, Web of Science, and Google Scholar. Furthermore, we performed separate searches for randomized trials that addressed the effects of thromboprophylaxis. STUDY ELIGIBILITY CRITERIA: Eligible studies were observational studies that enrolled ≥50 adult patients who underwent noncancer gynecologic surgery procedures and that reported the absolute incidence of at least 1 of the following: symptomatic pulmonary embolism, symptomatic deep vein thrombosis, symptomatic venous thromboembolism, bleeding that required reintervention (including re-exploration and angioembolization), bleeding that led to transfusion, or postoperative hemoglobin level <70 g/L. METHODS: A teams of 2 reviewers independently assessed eligibility, performed data extraction, and evaluated the risk of bias of the eligible articles. We adjusted the reported estimates for thromboprophylaxis and length of follow-up and used the median value from studies to determine the cumulative incidence at 4 weeks postsurgery stratified by patient venous thromboembolism risk factors and used the Grading of Recommendations Assessment, Development and Evaluation approach to rate the evidence certainty. RESULTS: We included 131 studies (1,741,519 patients) that reported venous thromboembolism risk estimates for 50 gynecologic noncancer procedures and bleeding requiring reintervention estimates for 35 procedures. The evidence certainty was generally moderate or low for venous thromboembolism and low or very low for bleeding requiring reintervention. The risk for symptomatic venous thromboembolism varied from a median of <0.1% for several procedures (eg, transvaginal oocyte retrieval) to 1.5% for others (eg, minimally invasive sacrocolpopexy with hysterectomy, 1.2%-4.6% across patient venous thromboembolism risk groups). Venous thromboembolism risk was <0.5% for 30 (60%) of the procedures; 0.5% to 1.0% for 10 (20%) procedures; and >1.0% for 10 (20%) procedures. The risk for bleeding the require reintervention varied from <0.1% (transvaginal oocyte retrieval) to 4.0% (open myomectomy). The bleeding requiring reintervention risk was <0.5% in 17 (49%) procedures, 0.5% to 1.0% for 12 (34%) procedures, and >1.0% in 6 (17%) procedures. CONCLUSION: The risk for venous thromboembolism in gynecologic noncancer surgery varied between procedures and patients. Venous thromboembolism risks exceeded the bleeding risks only among selected patients and procedures. Although most of the evidence is of low certainty, the results nevertheless provide a compelling rationale for restricting pharmacologic thromboprophylaxis to a minority of patients who undergo gynecologic noncancer procedures.

Systematic Reviews and Meta-analyses of the Procedure-specific Risks of Thrombosis and Bleeding in General Abdominal, Colorectal, Upper Gastrointestinal, and Hepatopancreatobiliary Surgery.

OBJECTIVE: To provide procedure-specific estimates of symptomatic venous thromboembolism (VTE) and major bleeding after abdominal surgery. BACKGROUND: The use of pharmacological thromboprophylaxis represents a trade-off that depends on VTE and bleeding risks that vary between procedures; their magnitude remains uncertain. METHODS: We identified observational studies reporting procedure-specific risks of symptomatic VTE or major bleeding after abdominal surgery, adjusted the reported estimates for thromboprophylaxis and length of follow-up, and estimated cumulative incidence at 4 weeks postsurgery, stratified by VTE risk groups, and rated evidence certainty. RESULTS: After eligibility screening, 285 studies (8,048,635 patients) reporting on 40 general abdominal, 36 colorectal, 15 upper gastrointestinal, and 24 hepatopancreatobiliary surgery procedures proved eligible. Evidence certainty proved generally moderate or low for VTE and low or very low for bleeding requiring reintervention. The risk of VTE varied substantially among procedures: in general abdominal surgery from a median of <0.1% in laparoscopic cholecystectomy to a median of 3.7% in open small bowel resection, in colorectal from 0.3% in minimally invasive sigmoid colectomy to 10.0% in emergency open total proctocolectomy, and in upper gastrointestinal/hepatopancreatobiliary from 0.2% in laparoscopic sleeve gastrectomy to 6.8% in open distal pancreatectomy for cancer. CONCLUSIONS: VTE thromboprophylaxis provides net benefit through VTE reduction with a small increase in bleeding in some procedures (eg, open colectomy and open pancreaticoduodenectomy), whereas the opposite is true in others (eg, laparoscopic cholecystectomy and elective groin hernia repairs). In many procedures, thromboembolism and bleeding risks are similar, and decisions depend on individual risk prediction and values and preferences regarding VTE and bleeding.

Risk of thrombosis and bleeding in gynecologic cancer surgery: systematic review and meta-analysis.

OBJECTIVE: This study aimed to provide procedure-specific estimates of the risk of symptomatic venous thromboembolism and major bleeding in the absence of thromboprophylaxis, following gynecologic cancer surgery. DATA SOURCES: We conducted comprehensive searches on Embase, MEDLINE, Web of Science, and Google Scholar for observational studies. We also reviewed reference lists of eligible studies and review articles. We performed separate searches for randomized trials addressing effects of thromboprophylaxis and conducted a web-based survey on thromboprophylaxis practice. STUDY ELIGIBILITY CRITERIA: Observational studies enrolling ≥50 adult patients undergoing gynecologic cancer surgery procedures reporting absolute incidence for at least 1 of the following were included: symptomatic pulmonary embolism, symptomatic deep vein thrombosis, symptomatic venous thromboembolism, bleeding requiring reintervention (including reexploration and angioembolization), bleeding leading to transfusion, or postoperative hemoglobin <70 g/L. METHODS: Two reviewers independently assessed eligibility, performed data extraction, and evaluated risk of bias of eligible articles. We adjusted the reported estimates for thromboprophylaxis and length of follow-up and used the median value from studies to determine cumulative incidence at 4 weeks postsurgery stratified by patient venous thromboembolism risk factors. The GRADE approach was applied to rate evidence certainty. RESULTS: We included 188 studies (398,167 patients) reporting on 37 gynecologic cancer surgery procedures. The evidence certainty was generally low to very low. Median symptomatic venous thromboembolism risk (in the absence of prophylaxis) was <1% in 13 of 37 (35%) procedures, 1% to 2% in 11 of 37 (30%), and >2.0% in 13 of 37 (35%). The risks of venous thromboembolism varied from 0.1% in low venous thromboembolism risk patients undergoing cervical conization to 33.5% in high venous thromboembolism risk patients undergoing pelvic exenteration. Estimates of bleeding requiring reintervention varied from <0.1% to 1.3%. Median risks of bleeding requiring reintervention were <1% in 22 of 29 (76%) and 1% to 2% in 7 of 29 (24%) procedures. CONCLUSION: Venous thromboembolism reduction with thromboprophylaxis likely outweighs the increase in bleeding requiring reintervention in many gynecologic cancer procedures (eg, open surgery for ovarian cancer and pelvic exenteration). In some procedures (eg, laparoscopic total hysterectomy without lymphadenectomy), thromboembolism and bleeding risks are similar, and decisions depend on individual risk prediction and values and preferences regarding venous thromboembolism and bleeding.

Practice Variation in the Management of Adult Hydroceles: A Multinational Survey.

Background: Although hydrocele is one of the most common urologic pathologies, it is seldom studied, and the major urologic associations have no guidelines for the management of adult hydroceles. Objective: To characterize international practice variation in the treatment of adult hydroceles. Design setting and participants: An international survey was conducted addressing the management of hydroceles among urologists in Belgium, Denmark, Finland, Iceland, Japan, and the Netherlands from September to December 2020. We invited a random sample of 170 urologists from each country (except Iceland). Outcome measurements and statistical analysis: Urologists' treatment options, factors relevant for decision-making, expected patient satisfaction, and outcomes after aspiration versus surgery were assessed. Results and limitations: Of the 864 urologists contacted, 437 (51%) participated. Of the respondents, 202 (53%) performed both hydrocelectomies and aspiration, 147 (39%) performed hydrocelectomies only, and 30 (8%) performed aspiration only. In Belgium (83%), the Netherlands (75%), and Denmark (55%), urologists primarily performed hydrocelectomies only, whereas in Finland (84%), Japan (61%), and Iceland (91%), urologists performed both hydrocelectomies and aspiration. Urologists favored hydrocelectomy for large hydroceles (78.8% vs 37.5% for small), younger patients (66.0% for patients <50 yr vs 41.2% for ≥70 yr), patients with few or no comorbidities (62.3% vs 23.1% with multiple comorbidities), and patients without antithrombotic agents (53.5% vs 36.5% with antithrombotic agents). Most urologists considered patient satisfaction to be highest after hydrocelectomy (53.8% vs 9.9% after aspiration) despite believing that hydrocelectomy is more likely to cause complications (hematoma 77.8% vs 8.8% after aspiration). Estimates varied between countries. Conclusions: We found a large variation in the treatment of adult hydroceles within and between countries. Optimization of hydrocele management globally will require future studies. Patient summary: Our international survey shows that treatment of adult hydrocele varies considerably within and between countries.

Summary Paper on the 2023 European Association of Urology Guidelines on the Management of Non-neurogenic Male Lower Urinary Tract Symptoms.

CONTEXT: Lower urinary tract symptoms (LUTS) are common, often bothersome, and have multifactorial aetiology. OBJECTIVE: To present a summary of the 2023 version of the European Association of Urology guidelines on the management of male LUTS. EVIDENCE ACQUISITION: A structured literature search from 1966 to 2021 selected the articles with the highest certainty evidence. The Delphi technique consensus approach was used to develop the recommendations. EVIDENCE SYNTHESIS: The assessment of men with LUTS should be practical. A careful medical history and physical examination are essential. Validated symptom scores, urine test, uroflowmetry, and postvoid urine residual, as well as frequency-volume charts for patients with nocturia or predominately storage symptoms should be used. Prostate-specific antigen should be ordered if a diagnosis of prostate cancer changes the treatment plan. Urodynamics should be performed for selected patients. Men with mild symptoms are candidates for watchful waiting. Behavioural modification should be offered to men with LUTS prior to, or concurrent with, treatment. The choice of medical treatment depends on the assessment findings, predominant type of symptoms, ability of the treatment to change the findings, and the expectations to be met in terms of the speed of onset, efficacy, side effects, and disease progression. Surgery is reserved for men with absolute indications, and for patients who fail or prefer not to receive medical therapy. Surgical management has been divided into five sections: resection, enucleation, vaporisation, and alternative ablative and nonablative techniques. The choice of surgical technique depends on patient's characteristics, expectations, and preferences; surgeon's expertise; and availability of modalities. CONCLUSIONS: The guidelines provide an evidence-based approach for the management of male LUTS. PATIENT SUMMARY: A clinical assessment should identify the cause(s) of symptoms and define the clinical profile and patient's expectations. The treatment should aim to ameliorate symptoms and reduce the risk of complications.

Timing of symptomatic venous thromboembolism after surgery: meta-analysis.

BACKGROUND: The timing at which venous thromboembolism (VTE) occurs after major surgery has major implications for the optimal duration of thromboprophylaxis. The aim of this study was to perform a systematic review and meta-analysis of the timing of postoperative VTE up to 4 weeks after surgery. METHODS: A systematic search of MEDLINE, Scopus, and CINAHL databases was performed between 1 January 2009 and 1 April 2022. Prospective studies that recruited patients who underwent a surgical procedure and reported at least 20 symptomatic, postoperative VTE events by time were included. Two reviewers independently selected studies according to the eligibility criteria, extracted data, and evaluated risk of bias. Data were analysed with a Poisson regression model, and the GRADE approach was used to rate the certainty of evidence. RESULTS: Some 6258 studies were evaluated, of which 22 (11 general, 5 urological, 4 mixed, and 2 orthopaedic postoperative surgical populations; total 1 864 875 patients and 24 927 VTE events) were eligible. Pooled evidence of moderate certainty showed that 47.1 per cent of the VTE events occurred during the first, 26.9 per cent during the second, 15.8 per cent during the third, and 10.1 per cent during the fourth week after surgery. The timing of VTE was consistent between individual studies. CONCLUSION: Although nearly half of symptomatic VTE events in first 4 weeks occur during the first postoperative week, a substantial number of events occur several weeks after surgery. These data will inform clinicians and guideline developers about the duration of postoperative thromboprophylaxis.

Hundreds of millions of surgical procedures are performed annually worldwide. Blood clots in legs and lungs represent serious, and sometimes fatal, complications of surgery. To prevent these complications, clinicians often give blood thinners to patients. To optimize the starting time and duration of use of blood thinners, it is crucial to know when blood clots occur after surgery. This study summarized the timing of blood clots after surgery based on a systematic review and meta-analysis of 22 prospective studies including thousands of patients with blood clots from various surgical fields. Of blood clots occurring within 4 weeks after surgery, 47 per cent occurred by the first, 74 per cent by the second, and 90 per cent by the third week after surgery. These research results are useful for patients, clinicians, and guideline developers to guide the starting time and duration of use of blood thinners after surgery.

Risk of Complications After Hydrocele Surgery: A Retrospective Multicenter Study in Helsinki Metropolitan Area.

Background: Despite being one of the most frequent urological procedures, the risk estimates for complications after hydrocele surgery (hydrocelectomy) are uncertain. Decision-making about hydrocelectomy involves balancing the risk of complications with efficacy of surgery-a tradeoff that critically depends on the complication risks of hydrocele surgery. Objective: To examine the 90-d risks of complications of hydrocele surgery in a large, contemporary sample. Design setting and participants: We retrospectively reviewed all surgeries performed for nonrecurrent hydroceles conducted in all five Helsinki metropolitan area public hospitals from the beginning of 2010 till the end of 2018, and evaluated the complication outcomes. Outcome measurements and statistical analysis: The following outcomes were evaluated: (1) risk of moderate or severe (Clavien-Dindo II-V) hydrocele surgery complications, (2) risk of reoperation due to a surgical complication, and (3) risk of an unplanned postoperative visit to the emergency room or outpatient clinic, all within 90 d after surgery. Results and limitations: We identified 866 hydrocele operations (38 [4.3%] bilateral operations). A total of 139 (16.1%) patients had moderate or severe hydrocele surgery complications within 90 d after surgery. Of the 139 complications, 94 were (10.9% of all or 67.6% of patients with moderate or severe complications) Clavien-Dindo grade II, 43 (5.0% and 30.9%, respectively) grade III, two (0.2% and 1.4%, respectively) grade IV, and none grade V. A total of 45 patients (5.2% of all and 32.4% of those who had moderate or severe complications) required immediate reoperation due to complications. All together 219 operated patients (25.3% of all operated patients) had an unplanned visit to the emergency room. The retrospective study design limits the reliability of the results. Conclusions: Complications after hydrocele surgery are common and warrant further research. These estimates can be useful in shared decision-making between clinicians and patients. Patient summary: We investigated the complication rates after hydrocele surgery and found that complications are common after a procedure often considered minor: every ninth patient had a moderate and every 20th a severe complication. Every fourth patient had an unplanned postoperative visit to the emergency room.

A systematic review and meta-analysis on delaying surgery for urothelial carcinoma of bladder and upper tract urothelial carcinoma: Implications for the COVID19 pandemic and beyond.

Purpose: The COVID-19 pandemic has led to competing strains on hospital resources and healthcare personnel. Patients with newly diagnosed invasive urothelial carcinomas of bladder (UCB) upper tract (UTUC) may experience delays to definitive radical cystectomy (RC) or radical nephro-ureterectomy (RNU) respectively. We evaluate the impact of delaying definitive surgery on survival outcomes for invasive UCB and UTUC. Methods: We searched for all studies investigating delayed urologic cancer surgery in Medline and Embase up to June 2020. A systematic review and meta-analysis was performed. Results: We identified a total of 30 studies with 32,591 patients. Across 13 studies (n = 12,201), a delay from diagnosis of bladder cancer/TURBT to RC was associated with poorer overall survival (HR 1.25, 95% CI: 1.09-1.45, p = 0.002). For patients who underwent neoadjuvant chemotherapy before RC, across the 5 studies (n = 4,316 patients), a delay between neoadjuvant chemotherapy and radical cystectomy was not found to be significantly associated with overall survival (pooled HR 1.37, 95% CI: 0.96-1.94, p = 0.08). For UTUC, 6 studies (n = 4,629) found that delay between diagnosis of UTUC to RNU was associated with poorer overall survival (pooled HR 1.55, 95% CI: 1.19-2.02, p = 0.001) and cancer-specific survival (pooled HR of 2.56, 95% CI: 1.50-4.37, p = 0.001). Limitations included between-study heterogeneity, particularly in the definitions of delay cut-off periods between diagnosis to surgery. Conclusions: A delay from diagnosis of UCB or UTUC to definitive RC or RNU was associated with poorer survival outcomes. This was not the case for patients who received neoadjuvant chemotherapy.

Including Information on Overdiagnosis in Shared Decision Making: A Review of Prostate Cancer Screening Decision Aids.

Background. Overdiagnosis is an accepted harm of cancer screening, but studies of prostate cancer screening decision aids have not examined provision of information important in communicating the risk of overdiagnosis, including overdiagnosis frequency, competing mortality risk, and the high prevalence of indolent cancers in the population. Methods. We undertook a comprehensive review of all publicly available decision aids for prostate cancer screening, published in (or translated to) the English language, without date restrictions. We included all decision aids from a recent systematic review and screened excluded studies to identify further relevant decision aids. We used a Google search to identify further decision aids not published in peer reviewed medical literature. Two reviewers independently screened the decision aids and extracted information on communication of overdiagnosis. Disagreements were resolved through discussion or by consulting a third author. Results. Forty-one decision aids were included out of the 80 records identified through the search. Most decision aids (n = 32, 79%) did not use the term overdiagnosis but included a description of it (n = 38, 92%). Few (n = 7, 17%) reported the frequency of overdiagnosis. Little more than half presented the benefits of prostate cancer screening before the harms (n = 22, 54%) and only 16, (39%) presented information on competing risks of mortality. Only 2 (n = 2, 5%) reported the prevalence of undiagnosed prostate cancer in the general population. Conclusion. Most patient decision aids for prostate cancer screening lacked important information on overdiagnosis. Specific guidance is needed on how to communicate the risks of overdiagnosis in decision aids, including appropriate content, terminology and graphical display. Highlights: Most patient decision aids for prostate cancer screening lacks important information on overdiagnosis.Specific guidance is needed on how to communicate the risks of overdiagnosis.

European Association of Urology Guidelines on Male Urinary Incontinence.

CONTEXT: Urinary incontinence (UI) is a common condition in elderly men causing a severe worsening of quality of life, and a significant cost for both patients and health systems. OBJECTIVE: To report a practical, evidence-based, guideline on definitions, pathophysiology, diagnostic workup, and treatment options for men with different forms of UI. EVIDENCE ACQUISITION: A comprehensive literature search, limited to studies representing high levels of evidence and published in the English language, was performed. Databases searched included Medline, EMBASE, and the Cochrane Libraries. A level of evidence and a grade of recommendation were assigned. EVIDENCE SYNTHESIS: UI can be classified into stress urinary incontinence (SUI), urge urinary incontinence (UUI), and mixed urinary incontinence. A detailed description of the pathophysiology and diagnostic workup has been reported. Simple clinical interventions, behavioural and physical modifications, and pharmacological treatments comprise the initial management for all kinds of UI. Surgery for SUI includes bulking agents, male sling, and compression devices. Surgery for UUI includes bladder wall injection of botulinum toxin A, sacral nerve stimulation, and cystoplasty/urinary diversion. CONCLUSIONS: This 2022 European Association of Urology guideline summary provides updated information on definition, pathophysiology, diagnosis, and treatment of male UI. PATIENT SUMMARY: Male urinary incontinence comprises a broad subject area, much of which has been covered for the first time in the literature in a single manuscript. The European Association of Urology Non-neurogenic Male Lower Urinary Tract Symptoms Guideline Panel has released this new guidance, with the aim to provide updated information for urologists to be able to follow diagnostic and therapeutic indications for optimising patient care.

Benefits and harms of direct oral anticoagulation and low molecular weight heparin for thromboprophylaxis in patients undergoing non-cardiac surgery: systematic review and network meta-analysis of randomised trials.

OBJECTIVE: To systematically compare the effect of direct oral anticoagulants and low molecular weight heparin for thromboprophylaxis on the benefits and harms to patients undergoing non-cardiac surgery. DESIGN: Systematic review and network meta-analysis of randomised controlled trials. DATA SOURCES: Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL), up to August 2021. REVIEW METHODS: Randomised controlled trials in adults undergoing non-cardiac surgery were selected, comparing low molecular weight heparin (prophylactic (low) or higher dose) with direct oral anticoagulants or with no active treatment. Main outcomes were symptomatic venous thromboembolism, symptomatic pulmonary embolism, and major bleeding. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for network meta-analyses. Abstracts and full texts were screened independently in duplicate. Data were abstracted on study participants, interventions, and outcomes, and risk of bias was assessed independently in duplicate. Frequentist network meta-analysis with multivariate random effects models provided odds ratios with 95% confidence intervals, and GRADE (grading of recommendations, assessment, development, and evaluation) assessments indicated the certainty of the evidence. RESULTS: 68 randomised controlled trials were included (51 orthopaedic, 10 general, four gynaecological, two thoracic, and one urological surgery), involving 45 445 patients. Low dose (odds ratio 0.33, 95% confidence interval 0.16 to 0.67) and high dose (0.19, 0.07 to 0.54) low molecular weight heparin, and direct oral anticoagulants (0.17, 0.07 to 0.41) reduced symptomatic venous thromboembolism compared with no active treatment, with absolute risk differences of 1-100 per 1000 patients, depending on baseline risks (certainty of evidence, moderate to high). None of the active agents reduced symptomatic pulmonary embolism (certainty of evidence, low to moderate). Direct oral anticoagulants and low molecular weight heparin were associated with a 2-3-fold increase in the odds of major bleeding compared with no active treatment (certainty of evidence, moderate to high), with absolute risk differences as high as 50 per 1000 in patients at high risk. Compared with low dose low molecular weight heparin, high dose low molecular weight heparin did not reduce symptomatic venous thromboembolism (0.57, 0.26 to 1.27) but increased major bleeding (1.87, 1.06 to 3.31); direct oral anticoagulants reduced symptomatic venous thromboembolism (0.53, 0.32 to 0.89) and did not increase major bleeding (1.23, 0.89 to 1.69). CONCLUSIONS: Direct oral anticoagulants and low molecular weight heparin reduced venous thromboembolism compared with no active treatment but probably increased major bleeding to a similar extent. Direct oral anticoagulants probably prevent symptomatic venous thromboembolism to a greater extent than prophylactic low molecular weight heparin. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018106181.

Does Protocol Make a Difference? Comparison of Two Prostate Cancer Active Surveillance Cohorts: A Non-protocol-based Follow-up and a Protocol-based Contemporary Follow-up.

BACKGROUND: Active surveillance (AS) is the preferred option for initial management for low-risk prostate cancer (PC). Although many AS protocols exist, there is little evidence to support one over another. OBJECTIVE: To assess whether there is difference in overall (OS), prostate cancer-specific (CSS), metastasis-free (MFS), or treatment-free (TFS) survival between a strict (Prostate cancer Research International: Active Surveillance [PRIAS]) and a loose (European Randomized study of Screening for Prostate Cancer [ERSPC]) AS protocol. DESIGN SETTING AND PARTICIPANTS: This study included two cohorts of men (n = 518) with low-risk, localized, Gleason score ≤7 PC. The ERSPC cohort included 241 men followed for 9.5 yr (median) with a non-protocol-based follow-up. The PRIAS cohort included 277 men followed for 5 yr (median) with a strict protocol. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: OS, CSS, MFS, and TFS were compared by the Kaplan-Meier method, competing risk analysis, and Cox proportional hazard regression. RESULTS AND LIMITATIONS: As expected, due to the difference in median follow-up time between the cohorts, a difference in the absolute number of events was seen. However, no difference in any of the survival outcomes was evident in the Kaplan-Meier or competing risks analysis. Furthermore, in Cox proportional hazard regression analysis, cohort (ERSPC vs PRIAS) was not associated with any of the outcomes. Results are limited by the retrospective study design, limited statistical power, and inability to match the cohorts for predictive factors. CONCLUSIONS: There was no difference in survival outcomes between a non-protocol-based follow-up and a protocol-based contemporary AS follow-up of patients with low-risk PC. However, a longer follow-up is needed. PATIENT SUMMARY: We compared survival outcomes of two cohorts of patients with low-risk prostate cancer: a strict and a loose follow-up protocol. We found no differences in survival measures between the cohorts.

Systematic reviews of observational studies of Risk of Thrombosis and Bleeding in General and Gynecologic Surgery (ROTBIGGS): introduction and methodology.

BACKGROUND: Venous thromboembolism (VTE) and bleeding are serious and potentially fatal complications of surgical procedures. Pharmacological thromboprophylaxis decreases the risk of VTE but increases the risk of major post-operative bleeding. The decision to use pharmacologic prophylaxis therefore represents a trade-off that critically depends on the incidence of VTE and bleeding in the absence of prophylaxis. These baseline risks vary widely between procedures, but their magnitude is uncertain. Systematic reviews addressing baseline risks are scarce, needed, and require innovations in methodology. Indeed, systematic summaries of these baseline risk estimates exist neither in general nor gynecologic surgery. We will fill this knowledge gap by performing a series of systematic reviews and meta-analyses of the procedure-specific and patient risk factor stratified risk estimates in general and gynecologic surgeries. METHODS: We will perform comprehensive literature searches for observational studies in general and gynecologic surgery reporting symptomatic VTE or bleeding estimates. Pairs of methodologically trained reviewers will independently assess the studies for eligibility, evaluate the risk of bias by using an instrument developed for this review, and extract data. We will perform meta-analyses and modeling studies to adjust the reported risk estimates for the use of thromboprophylaxis and length of follow up. We will derive the estimates of risk from the median estimates of studies rated at the lowest risk of bias. The primary outcomes are the risk estimates of symptomatic VTE and major bleeding at 4 weeks post-operatively for each procedure stratified by patient risk factors. We will apply the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate evidence certainty. DISCUSSION: This series of systematic reviews, modeling studies, and meta-analyses will inform clinicians and patients regarding the trade-off between VTE prevention and bleeding in general and gynecologic surgeries. Our work advances the standards in systematic reviews of surgical complications, including assessment of risk of bias, criteria for arriving at the best estimates of risk (including modeling of the timing of events and dealing with suboptimal data reporting), dealing with subgroups at higher and lower risk of bias, and use of the GRADE approach. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021234119.

ARTS: A Large, International Trial of Thromboprophylaxis in Intra-abdominal, Gynecologic, and Urologic Surgery.

ARTS will be the first trial to compare anticoagulation with a direct oral anticoagulant (apixaban) versus no anticoagulation among patients undergoing intra-abdominal, gynecologic, or urologic surgery at sufficiently similar risk of deep vein thrombosis or pulmonary embolism and major bleeding.

A Systematic Review of Patients' Values, Preferences, and Expectations for the Diagnosis and Treatment of Male Lower Urinary Tract Symptoms.

CONTEXT: Understanding men's values and preferences in the context of personal, physical, emotional, relational, and social factors is important in optimising patient counselling, facilitating treatment decision-making, and improving guideline recommendations. OBJECTIVE: To systematically review the available evidence regarding the values, preferences, and expectations of men towards the investigation and treatment (conservative, pharmacological, and surgical) of male lower urinary tract symptoms (LUTS). EVIDENCE ACQUISITION: We searched electronic databases until August 31, 2020 for quantitative and qualitative studies that reported values and preferences regarding the investigation and treatment of LUTS in men. We assessed the quality of evidence and risk of bias using the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) and GRADE Confidence in the Evidence from Reviews of Qualitative Research (CERQual) approaches. EVIDENCE SYNTHESIS: We included 25 quantitative studies, three qualitative studies, and one mixed-methods study recruiting 9235 patients. Most men reported urodynamic testing to be acceptable, despite discomfort or embarrassment, as it significantly informs treatment decisions (low certainty evidence). Men preferred conservative and less risky treatment options, but the preference varied depending on baseline symptom severity and the risk/benefit characteristics of the treatment (moderate certainty). Men preferred pharmacological treatments with a low risk of erectile dysfunction and those especially improving urgency incontinence (moderate certainty). Other important preference considerations included reducing the risk of acute urinary retention or surgery (moderate certainty). CONCLUSIONS: Men prefer lower-risk management options that have fewer sexual side effects and are primarily effective at improving urgency incontinence and nocturia. Overall, the evidence was rated to be of low to moderate certainty. This review can facilitate the treatment decision-making process and improve the trustworthiness of guideline recommendations. PATIENT SUMMARY: We thoroughly reviewed the evidence addressing men's values and preferences regarding the management of urinary symptoms and found that minimising adverse effects is particularly important. Further research to understand other factors that matter to men is required.