BACKGROUND: Current guidelines endorse laparoscopy for non-obstetric abdominal surgery during pregnancy regardless of trimester, but recent data suggest trimester-specific fetal risks. This study compared maternal and fe...BACKGROUND: Current guidelines endorse laparoscopy for non-obstetric abdominal surgery during pregnancy regardless of trimester, but recent data suggest trimester-specific fetal risks. This study compared maternal and fetal safety of laparoscopic versus open surgery, focusing on trimester-specific and pathology-stratified outcomes. METHODS: A systematic review and meta-analysis followed PRISMA 2020 (CRD420261295995). PubMed, Embase and Cochrane Library were searched for comparative studies (randomised controlled trials and cohort studies) of laparoscopic versus open surgery for acute appendicitis, gallstone disease and adnexal masses. Random-effects meta-analysis synthesised data on fetal loss, preterm delivery, maternal complications and hospital stay. RESULTS: Twenty-two studies comprising 28,160 pregnant women (15,786 laparoscopic, 12,374 open) were included. Laparoscopy was associated with a higher risk of fetal loss than open surgery (Odds ratio (OR) 2.02; 95% CI 1.40-2.92; P < 0.001). A first-trimester subgroup analysis showed a persistent trend towards higher fetal loss with laparoscopy (OR 1.35; 95% CI 0.84-2.19). Laparoscopy reduced preterm delivery (OR 0.56; 95% CI 0.34-0.94; P = 0.020) and maternal complications (OR 0.45; 95% CI 0.30-0.68; P < 0.001). Trimester-specific analysis revealed a significantly elevated risk of composite adverse fetal outcomes for laparoscopy during the second trimester (OR 2.35; 95% CI 1.15-4.77; P = 0.020) and a similar trend in the third trimester. CONCLUSION: Laparoscopy confers maternal benefits and reduces preterm delivery but is associated with higher fetal loss and elevated composite adverse outcomes in the second trimester.
INTRODUCTION: The gut microbiome is a fundamental determinant of gastrointestinal physiology. It is essential in maintaining host homeostasis while also implicated in cancer pathogenesis and alteration in physiological r...INTRODUCTION: The gut microbiome is a fundamental determinant of gastrointestinal physiology. It is essential in maintaining host homeostasis while also implicated in cancer pathogenesis and alteration in physiological response to surgical stress. This narrative review evaluates the microbiome's mechanistic role in surgical oncology, assessing it as a biomarker for risk stratification and an emerging therapeutic target. METHOD: The current literature was synthesized to examine microbial impacts on tumourigenesis and perioperative surgical outcomes across the lower and upper gastrointestinal tracts (including the gut-lung axis), the hepatopancreatobiliary system, and extra-abdominal malignancies (breast cancer and melanoma). RESULTS: Dysbiotic microbial signatures, termed the oncobiome, actively drive tumour progression and immune evasion. Perioperative interventions induce acute microbial shifts linked to serious complications such as anastomotic leaks and pneumonia. Clinically, targeted modulation yields significant benefits as demonstrated by: perioperative synbiotics reducing infectious complications by 45% in colorectal surgery and 64% in major liver surgery. Furthermore, preoperative oral care reduces post-esophagectomy pneumonia by up to 50%, while Helicobacter pylori eradication halves metachronous gastric cancer risk. However, a detrimental "antibiotic paradox" exists in melanoma, where pre-treatment antibiotic exposure severely impairs immune checkpoint inhibitor efficacy. Conversely, faecal microbiota transplantation can reverse this immunotherapy resistance, achieving up to 80% response rates in trials. CONCLUSION: The microbiome is a critical, modifiable determinant of both short-term surgical recovery and long-term oncologic survival. Future surgical oncology practice will need to integrate precision surgical microbiome-mediated biotherapeutics to optimise outcomes in multidisciplinary cancer care.
INTRODUCTION: Colorectal cancer (CRC) incidence is rising, consequentially traditional follow-up care models are increasingly unsustainable. Patient-led, home-based follow-up (PHFU) may offer a promising alternative to r...INTRODUCTION: Colorectal cancer (CRC) incidence is rising, consequentially traditional follow-up care models are increasingly unsustainable. Patient-led, home-based follow-up (PHFU) may offer a promising alternative to reduce hospital visits while maintaining patient well-being. METHODS: The DISTANCE trial is a stepped-wedge cluster randomised trial conducted in six hospitals in the Netherlands. A total of 354 stage I-III CRC survivors, disease-free at 12 months post-surgery, assigned to either PHFU or standard follow-up. The primary endpoint was the number of hospital contacts. Secondary endpoints included quality of life (QoL, EORTC QLQ-C30), cancer-related worry (CWS), and psychological distress (HADS). RESULTS: In the intention-to-treat (ITT) analysis, no significant difference in hospital contacts was observed. In the as-treated (AT) analysis, PHFU reduced hospital contacts by 38% compared to standard follow-up (RR 0.62, 95% CI 0.51-0.75, p < 0.001). There was substantial crossover, with 117 patients assigned to PHFU receiving standard follow-up and 10 patients assigned to standard follow-up receiving PHFU. No significant differences were found in QoL or psychological distress between the two groups. CONCLUSION: The DISTANCE trial suggests that PHFU is a feasible and effective alternative to standard hospital-based follow-up for CRC survivors.TOC Summary.
Sobnach S, Bayadsi H, Kotze U
… +10 more, Nyström H, Spearman CW, Sonderup M, Kim I, Venter K, Bernon M, Emmamally M, Zerbini LF, Hemmingsson O, Jonas E
INTRODUCTION: Sub-Saharan Africa carries a disproportionate burden of hepatocellular carcinoma, yet clinical guidelines used on the African sub-continent are extrapolated from high-income countries. The presentation, tre...INTRODUCTION: Sub-Saharan Africa carries a disproportionate burden of hepatocellular carcinoma, yet clinical guidelines used on the African sub-continent are extrapolated from high-income countries. The presentation, treatment and outcomes of hepatocellular carcinoma between liver referral centres in South Africa and Sweden were compared to examine the limitations of applying high-income countries-derived guidelines in sub-Saharan Africa. METHODS: This was a comparative cohort study of adult patients with hepatocellular carcinoma treated from 2012 to 2023 in a referral centre in South Africa and Sweden respectively. Main outcome was overall survival. Secondary outcome was treatment-specific survival. RESULTS: Of 959 patients included 455 and 504 were treated in South-Africa and Sweden respectively. Patients in South Africa were younger (median 50 vs. 71 years, P<0.001) and predominantly had hepatitis B virus-related hepatocellular carcinoma (60% vs. 3.6%, P<0.001). They presented with more advanced liver dysfunction, more frequent metastases and had more advanced BCLC stages. Curative-intended therapies (ablation, liver resection, liver transplantation) were offered to 9.2% and 42.5% of patients respectively (P<0.001). One, three, and five-year survival were 17.8%, 7.7% and 5.3%, respectively versus 58.9%, 35.3% and 26.2% respectively (P<0.001). Survival was consistently lower in the patients in South Africa when comparing treatment-specific cohorts. CONCLUSIONS: Marked disparities in disease presentation, access to treatment and survival were observed between regions. Tailored regional guidelines are urgently needed to address these inequities and improve outcomes.
Stoop TF, Seelen LWF, van 't Land FR
… +49 more, Scheepens JCM, Ali M, van der Hout AC, van der Kolk BM, Bonsing BA, Lips DJ, Manusama ER, Willemsen FEJA, Daams F, Kazemier G, Patijn GA, de Hingh IH, Wijsman JH, Schreinemakers J, Erdmann JI, Mieog JSD, Klaase JM, Rietjens JAC, Bosscha K, Beuk LPM, Nijkamp MW, den Dulk M, Kop MPM, Liem MSL, Luyer M, Stommel MWJ, Busch OR, Festen S, Bouwense S, Karsten TM, van Ravens TW, Neumann UP, de Meijer VE, Nieuwenhuijs VB, Draaisma WA, Derksen W, Bollen TL, Groot Koerkamp B, van Eijck CHJ, Quintus Molenaar I, Wolfgang CL, Del Chiaro M, Katz MHG, Hackert T, Wilmink JW, van Santvoort HC, de Wilde RF, Besselink MG, Dutch Pancreatic Cancer Group
BACKGROUND: In expert centers, surgical resection rates of locally advanced pancreatic cancer (LAPC) following induction chemotherapy have increased beyond 20% with subsequent 25% five-year overall survival (OS). In the...BACKGROUND: In expert centers, surgical resection rates of locally advanced pancreatic cancer (LAPC) following induction chemotherapy have increased beyond 20% with subsequent 25% five-year overall survival (OS). In the Netherlands, however, the historical low 8% LAPC resection rate compared with 23% in international expert centers reflects relative reluctance. Thereby, opportunities to achieve long-term survival in appropriately selected patients may be missed. This study evaluated whether nationwide implementation of international multidisciplinary best-practice for LAPC management is feasible while maintaining surgical safety benchmarks (in-hospital/30-day major morbidity <50% and mortality ≤5%). METHODS: A multidisciplinary protocol was designed in collaboration with four international experts and prospectively implemented nationwide within the Dutch Pancreatic Cancer Group (DPCG) (2022-2024). This observational cohort included consecutive patients diagnosed with LAPC, defined by DPCG criteria. Eligible patients had radiologically non-progressive disease after at least four months of multi-agent chemotherapy. All patients who underwent resection were included in this safety analysis. A predefined sub-group analysis included patients with National Comprehensive Cancer Network (NCCN) LAPC. Primary outcomes included in-hospital/30-day major morbidity (i.e., Clavien-Dindo grade ≥IIIa) and mortality. The expected number of resections was 53. RESULTS: Overall, 180 patients with LAPC underwent surgical exploration, of whom 155 (86%) underwent resection in 11 centers. Most (74%) resections were performed in the three LAPC surgical centers. Extended resections were performed in 77% of patients, including portomesenteric venous (60%), multivisceral (23%), and arterial (21%) resections. In-hospital/30-day major morbidity rate was 44% and mortality rate was 0.6%, both within pre-established safety benchmarks. Benchmarks were also reached for patients with NCCN LAPC (49% major morbidity, 2% mortality). CONCLUSION: Nationwide implementation of the international best-practice for LAPC was feasible with nearly three times more resections performed than expected, while morbidity and mortality remained well within predefined safety benchmarks.
de Vreeze LE, Maat SC, Anema JR
… +10 more, van Baren R, Been JV, Bender MHM, van Dongen HM, Langeveld-Benders HR, Visschers RGJ, Twisk JWR, Zijp GW, van Heurn ELW, Derikx JPM
INTRODUCTION: Several ultrasound risk stratification systems have been developed mainly with the aim of identifying benign lesions and thereby avoiding unnecessary fine needle aspiration (FNA) cytology. This randomized c...INTRODUCTION: Several ultrasound risk stratification systems have been developed mainly with the aim of identifying benign lesions and thereby avoiding unnecessary fine needle aspiration (FNA) cytology. This randomized controlled trial assessed if the use of an ultrasound risk stratification system improved identification of lesions requiring surgical treatment. MATERIAL AND METHODS: This was a multi-centre, unblinded and interventional randomized trial comparing selective and non-selective FNA in Western Sweden. Patients were randomized to either selective cytology according to EU-TIRADS criteria or non-selective cytology. RESULTS: A total of 195 patients were included, 93 in the non-selective group and 102 in the selective group, between February 2022 and December 2023. The frequency of nodules with Bethesda category IV-VI (primary outcome) was higher in the selective group (26% versus 13%, p=0.039). The rate of malignancy (secondary outcome) was similar in both groups; 8% in the selective group versus 5% in the non-selective group. The frequency of patients undergoing cytology was reduced from 83% in the non-selective group, to 71% in the selective group. Considering only patients with at least one nodule yielding EU-TIRADS 3 or higher, cytology was omitted in 7% of patients in the selective group, whereas no cytology was omitted in the non-selective group. CONCLUSION: This randomized controlled trial supports the use of EU-TIRADS to correctly select neoplastic nodules for FNA without missing thyroid cancer. The proportion of patients where FNA can be safely omitted using EU-TIRADS may however be exaggerated, indicating a need for further refinement of risk stratification systems for thyroid cancer diagnostics.
Fadel MG, Walshaw J, Yiasemidou M
… +23 more, Boal M, Pecchini F, Elhadi M, Massey LH, Carrano FM, Fehervari M, Walsh CM, Boshier PR, Eckhoff J, Buckle P, European Robotic Surgery Consensus (ERSC) Study Group
, Gisbertz SS, Bouvy N, Arezzo A, Perretta S, Nickel F, Khan J, Hanna GB, Seeliger B, Antoniou SA, Fuchs HF, Francis NK, Kontovounisios C
BACKGROUND: The rapid adoption of robotic surgical systems globally has created a critical gap in training, assessment, and certification for visceral and gastrointestinal (GI) surgical trainees. This study, led by the E...BACKGROUND: The rapid adoption of robotic surgical systems globally has created a critical gap in training, assessment, and certification for visceral and gastrointestinal (GI) surgical trainees. This study, led by the European Association for Endoscopic Surgery (EAES), aimed to achieve an international consensus on a structured, platform-agnostic robotic training curriculum for GI surgical trainees. METHODS: A 106-item Delphi questionnaire was developed with an international committee of surgical experts, trainees, methodologists, and patient representatives. It was disseminated to a multidisciplinary panel of 83 GI robotic surgeons, trainees, human factor experts, robotic theatre team members, and industry providers. Two Delphi survey rounds were conducted, with a priori consensus standard set at 70% or higher for agreement. A consensus meeting was subsequently held to discuss and finalise the items needed for a robotic training curriculum for GI surgery trainees. RESULTS: Seventy-one (86%) participants from 15 countries completed round one. A total of 82 items (77%) reached consensus and 32 new items were generated from free-text comments. Seventy of these participants (99%) completed the 56-item round two questionnaire, with 36 items (64%) reaching consensus and 5 new items generated. All 143 statements were discussed in the meeting and consensus was reached in the following areas: (i) key knowledge requirements of the bedside assistant and console surgeon; (ii) training components; (iii) performance assessment; and (iv) certification and supervision. CONCLUSION: International surgical experts, trainees, and other key stakeholders reached consensus on the critical components of a platform-agnostic robotic training curriculum for GI surgical trainees. This will help shape the future of robotic surgical education and certification, promote standardised training practices, and ultimately benefit patient safety and outcomes.
INTRODUCTION: Sexual misconduct in surgery is recognised as widespread, yet individuals within the same departments report markedly different perceptions of prevalence. Quantitative data show gender differences in experi...INTRODUCTION: Sexual misconduct in surgery is recognised as widespread, yet individuals within the same departments report markedly different perceptions of prevalence. Quantitative data show gender differences in experiences, but reasons for this remain unclear. This study explored perceptions of sexual misconduct in the UK surgical workplace and developed a heuristic framework. METHODS: Qualitative analysis was undertaken of free-text responses from 742 participants in a 2022 nationwide UK survey. Respondents included students, trainees and consultants. Inductive, reflexive thematic analysis within a constructionist paradigm was conducted, with iterative coding by two researchers and team discussions to refine themes and develop an explanatory framework. RESULTS: Accounts diverged. Some participants described respectful workplaces with little misconduct, while others reported pervasive harassment, assault and inaction. Using an X-ray metaphor, the "Lateral View X-ray" theory was developed to explain this. The "AP View" reflects unawareness or minimisation, sustained by limited exposure, normalisation as banter, defensiveness, and seniority-related distancing. The "Lateral View" reflects heightened awareness from personal or witnessed experiences, hypervigilance, frustration at inaction, and informal warning networks. Male victims described additional barriers to recognition and disclosure. Drawing on standpoint and epistemic injustice theory, this work demonstrates how social position, power and language shape whether misconduct is recognised or obscured. CONCLUSION: The Lateral View X-ray theory explains how sexual misconduct can be simultaneously pervasive and invisible within surgery. Awareness depends on vantage point, where those least exposed perceive little problem, whereas those affected perceive structural harm. Embedding this framework in surgical education may widen perspective, improve responses and support cultural change.
BACKGROUND: Recurrence is a major driver of poor long-term outcomes after curative-intent resection for intrahepatic cholangiocarcinoma (iCCA), yet the association between postoperative pathology, first recurrence patter...BACKGROUND: Recurrence is a major driver of poor long-term outcomes after curative-intent resection for intrahepatic cholangiocarcinoma (iCCA), yet the association between postoperative pathology, first recurrence patterns, and post-recurrence outcomes remains unclear. METHODS: Patients who underwent curative-intent resection for iCCA (2000-2023) were identified from an international multi-institutional database. First recurrence patterns were classified as intrahepatic-only, extrahepatic-only, or combined intrahepatic and extrahepatic recurrence. Multivariable analyses assessed associations between postoperative pathologic features, first recurrence patterns, post-recurrence survival (PRS), and post-recurrence curative-intent treatment. RESULTS: Among 1,328 patients, 57.5% (n=763) recurred; 717 had a classifiable first recurrence pattern (intrahepatic-only, n=381; extrahepatic-only, n=171; combined, n=165). Three or more metastatic lymph nodes (adjusted odds ratio [aOR] 3.47, 95%CI 1.56-7.72) and microvascular invasion (aOR 2.49, 95%CI 1.61-3.85) were associated with higher odds of combined recurrence compared with intrahepatic-only recurrence, whereas perineural invasion (aOR 2.24, 95%CI 1.35-3.71) and absence of pathologic nodal evaluation (aOR 2.04, 95%CI 1.24-3.36) were associated with extrahepatic-only recurrence. Compared with intrahepatic-only recurrence, combined recurrence was associated with worse PRS (adjusted hazard ratio 1.63, 95%CI 1.29-2.06) and lower odds of receiving curative-intent treatment (aOR 0.14, 95%CI 0.06-0.29). CONCLUSIONS: Pathologic nodal burden and invasive tumour features were associated with distinct first recurrence patterns after iCCA resection. Combined recurrence, more common with three or more metastatic lymph nodes or microvascular invasion, was associated with worse PRS and lower receipt of curative-intent treatment. Among patients who develop recurrence, postoperatively available pathological prognostic factors may help characterise first recurrence patterns and inform risk-adapted postoperative surveillance.
INTRODUCTION: Good preoperative information is associated with reduced anxiety and improved postoperative pain, satisfaction, and quality of life. In the present study, we assessed sex-based disparities in perceived suff...INTRODUCTION: Good preoperative information is associated with reduced anxiety and improved postoperative pain, satisfaction, and quality of life. In the present study, we assessed sex-based disparities in perceived sufficiency of perioperative information among patients undergoing ventral hernia repair. METHODS: This study was part of the AFTERHERNIA Project, which included patients ≥18 years undergoing ventral hernia repair between January 2014 and March 2024. Patients identified via the Danish National Patient Register completed the Abdominal Hernia-Q, with responses linked to the Danish Ventral Hernia Database. Perceived sufficiency of perioperative information was assessed using three Abdominal Hernia-Q items: prepared for surgery, postoperative emotions, and recovery concerns. Multivariable analyses were adjusted for age, severe chronic pain, suspicion of recurrence, hernia characteristics, and surgical factors. RESULTS: Among 26,384 patients (10,108 females, 16,276 males; 79% [26,384 of 33,267] response rate), crude rates indicated that females were more often dissatisfied across all three items: prepared for surgery (14%vs9%), postoperative emotions (39%vs22%), and recovery concerns (34%vs22%). In adjusted analyses (n=23,201), females were also found to be more dissatisfied: prepared for surgery (OR 1.40;95%CI,1.28-1.53;P<0.001), postoperative emotions (OR 2.00;95%CI, 1.88-2.13;P<0.001), and recovery concerns (OR 1.61;95%CI,1.51-1.71;P<0.001). All three subgroup analyses showed similar patterns. Younger age, severe chronic pain, and suspicion of recurrence were independently associated with higher levels of dissatisfaction. CONCLUSION: These results show a possible sex-based disparity in perceived sufficiency of perioperative information, with higher dissatisfaction reported by females. These findings suggest that perioperative counselling may need to be tailored to better meet female patients' informational needs.
BACKGROUND: Prehabilitation is an emerging preoperative strategy designed to optimise patients' functional capacity before surgery to improve postoperative outcomes. Previous studies have demonstrated its clinical benefi...BACKGROUND: Prehabilitation is an emerging preoperative strategy designed to optimise patients' functional capacity before surgery to improve postoperative outcomes. Previous studies have demonstrated its clinical benefit, including enhanced recovery and reduced postoperative complications. However, the mechanisms underlying these benefits remain poorly understood. This exploratory study investigates the potential effects of prehabilitation on pre- and postoperative immune function. METHODS: This prospective study utilized data and material from a subgroup of patients participating in the F4S PREHAB trial, which is a stepped-wedge trial investigating the effects of multimodal prehabilitation prior to major surgery. In this substudy, patients undergoing elective bladder, oesophageal, or rectal cancer surgery between June 2022 and November 2023, were included. Immune function was assessed at baseline, following the prehabilitation or usual care period, and on postoperative day 1 (POD1) by examining ex vivo cytokine production capacity, plasma cytokine concentrations, and mHLA-DR expression. RESULTS: This substudy included 130 patients: 102 in the prehabilitation group and 28 in the control group. Following prehabilitation, ex vivo production of pro-inflammatory cytokines was reduced, while ex vivo production of the anti-inflammatory cytokine IL-10 was increased. Plasma concentrations of IL-6 and IL-10 were decreased following prehabilitation. On POD1, no significant differences in postoperative immune function were observed between the prehabilitation and control groups. CONCLUSION: This study suggests that multimodal prehabilitation influences basal immune function, leading to a less inflammatory state. However, as no significant differences in immune function were observed between prehabilitation and control groups on POD1, the impact of prehabilitation on postoperative immune function may be limited.
INTRODUCTION: Staging laparoscopy (SL) enables direct detection of peritoneal disease (PD), including peritoneal dissemination (P1) and positive peritoneal cytology (CY1), which are often undetectable by preoperative ima...INTRODUCTION: Staging laparoscopy (SL) enables direct detection of peritoneal disease (PD), including peritoneal dissemination (P1) and positive peritoneal cytology (CY1), which are often undetectable by preoperative imaging in gastric cancer (GC). This study aimed to evaluate the diagnostic accuracy of SL and to develop a simple preoperative scoring system for predicting peritoneal disease. METHODS: A total of 889 patients with advanced GC who underwent SL were retrospectively reviewed. After excluding 128 post-chemotherapy cases, 761 treatment-naive patients were analyzed. Clinicopathologic variables were compared between PD- and PD+ groups, and predictors of peritoneal disease were identified. A simple predictive score was constructed based on significant independent factors. RESULTS: Peritoneal disease was detected at SL in 418 patients (54.9%). Positivity rates by indication were 61.7% for type 4, 51.1% for large type 3 (≥8 cm), 24.2% for bulky or para-aortic lymph node enlargement, and 76.8% for CT-suspected dissemination. The sensitivity, specificity, and accuracy of SL were 94.6%, 100%, and 96.8%, respectively. Multivariate analysis identified four independent predictors of peritoneal disease: CA19-9 >37 U/mL, CA125 >35 U/mL, poorly differentiated or signet-ring cell histology, and pan-regional tumor involvement. A scoring system (range 0-6) based on these variables demonstrated a stepwise increase in peritoneal disease incidence, from 32.4% for score 0 to 100% for score 6. CONCLUSIONS: SL offers excellent diagnostic performance for peritoneal disease in advanced GC. The proposed four-factor predictive score provides a simple and practical tool for estimating peritoneal disease risk, potentially allowing for more selective and rational use of SL.
INTRODUCTION: The short-term benefits of endovascular aortic repair (EVAR) compared with open repair for the treatment of abdominal aortic aneurysm (AAA) patients are well established. However, concerns have been raised...INTRODUCTION: The short-term benefits of endovascular aortic repair (EVAR) compared with open repair for the treatment of abdominal aortic aneurysm (AAA) patients are well established. However, concerns have been raised regarding a potential increased long-term cancer risk associated with EVAR, related to procedural and surveillance-related radiation exposure. The aim of this nationwide population-based cohort study was to evaluate whether EVAR is associated with an increased long-term cancer risk compared with open repair. METHODS: All patients undergoing primary AAA repair for an intact AAA (ICD-10: I71.4) from January 2005 to February 2024 were identified from the Swedish National Patient Register. Previous and subsequent cancer diagnoses, as well as previous co-morbidities, for this cohort were recorded. Cause of death was retrieved from the Cause of Death Register. Inverse probability of treatment weighting (IPTW) was applied using propensity scores derived from baseline characteristics and co-morbidities. Weighted Cox regression models, with EVAR as the sole regressor, were then fitted for the event of a new cancer diagnosis and cancer related death. RESULTS: Some 15 509 patients were identified (mean age of 73 years, 16.8% female, and 23.7% with a previous cancer diagnosis). After weighting, standardized mean differences for co-morbidities, age, sex, and recent hospital admissions were all within ±0.1. The median survival was 8.7 (95% c.i. 8.4 to 8.9) years for EVAR patients and 9.4 (95% c.i. 9.1 to 9.6) years for open repair patients. The median follow-up time was 4.9 (interquartile range (i.q.r.) 2.3 to 8.4) years for new cancer and 5.9 (i.q.r. 3.0 to 9.4) years for cancer-related death. Freedom from new cancer was lower in EVAR patients (HR 0.92 (95% c.i. 0.86 to 0.98)), whereas cancer-related survival was similar (HR 0.93 (95% c.i. 0.85 to 1.02)). CONCLUSION: EVAR was not associated with an increased risk of dying of cancer, but with an increased risk of being diagnosed with a new cancer. This should be interpreted carefully, as there is a clear risk of detection bias of otherwise unknown tumours due to routine imaging during EVAR surveillance.
BACKGROUND: Frailty is associated with mortality and adverse outcomes in chronic limb-threatening ischaemia (CLTI). Although prompt revascularization is recommended to reduce major adverse limb events (MALE), it is uncle...BACKGROUND: Frailty is associated with mortality and adverse outcomes in chronic limb-threatening ischaemia (CLTI). Although prompt revascularization is recommended to reduce major adverse limb events (MALE), it is unclear whether frailty modifies the relative effectiveness of surgical versus endovascular therapy. The aim of this study was to assess whether the outcomes of these strategies differ by frailty status in the BEST-CLI randomized trial. METHODS: A frailty index (FI; 0-1) was constructed using a deficit-accumulation approach; severe frailty was defined as an FI ≥0.45. The primary endpoint was MALE or death, and the safety endpoint was major adverse cardiovascular events (MACE). Patients with an adequate great saphenous vein (GSV) (cohort 1) and those requiring an alternative conduit (cohort 2) were analysed separately. RESULTS: Of 1830 randomized patients, the FI was calculable for 1754 patients. Severe frailty was present in 654 patients (47.6%) in cohort 1 and 187 patients (49.3%) in cohort 2 and was associated with higher MALE or death regardless of treatment. In cohort 1, surgical bypass reduced the risk of MALE or death in both severely frail patients (51.0% versus 67.2%; HR 0.68 (95% c.i. 0.55 to 0.83)) and non-severely frail patients (35.4% versus 48.2%; HR 0.68 (95% c.i. 0.54 to 0.86)) versus endovascular therapy (interaction P = 0.95). In cohort 2, outcomes were similar between treatment groups across frailty strata. No interaction was observed between frailty and treatment strategy for MACE. CONCLUSION: In the BEST-CLI trial, severe frailty was associated with higher MALE or death. Among patients suitable for bypass with an adequate GSV, surgical bypass was more effective than endovascular therapy irrespective of frailty status.
BACKGROUND: Lymphaticovenous anastomosis (LVA) is an increasingly applied microsurgical option for lymphoedema. The aim of this study was to evaluate the cost-effectiveness of LVA combined with complex decongestive thera...BACKGROUND: Lymphaticovenous anastomosis (LVA) is an increasingly applied microsurgical option for lymphoedema. The aim of this study was to evaluate the cost-effectiveness of LVA combined with complex decongestive therapy (CDT) versus CDT alone for breast cancer-related lymphoedema (BCRL). METHODS: A cost-effectiveness analysis was performed as a pre-specified secondary outcome of an RCT comparing LVA combined with CDT versus CDT alone. The primary outcome of the trial was health-related quality of life (HRQoL). A societal perspective with a 2-year time horizon was adopted. Quality-adjusted life-years (QALYs) were derived from the EuroQol five-dimension, five-level (EQ-5D-5L) questionnaire. Uncertainty was assessed using bootstrapping and sensitivity analysis. Data were collected from four Dutch hospitals. The primary outcome was the incremental cost-effectiveness ratio (ICER). RESULTS: One hundred female patients were included (mean age 58.5 years). Over 2 years, mean total costs were €16 234 (LVA) versus €14 293 (CDT); adjusted mean difference €78 (95% c.i. -€6044 to €6200). Mean(s.e.) QALYs were 1.636(0.003) (LVA) versus 1.579(0.002) (CDT); adjusted mean difference 0.045 (95% c.i. -0.021 to 0.112). The ICER from a societal perspective was €1716/QALY, with probabilities of cost-effectiveness of 0.60 and 0.71 at the €20 000 and €50 000 willingness-to-pay thresholds respectively. From a healthcare perspective, the ICER was €59 679/QALY, with probabilities of cost-effectiveness of 0.08 and 0.42 at the same thresholds respectively. CONCLUSION: LVA combined with CDT was more costly than CDT alone, but societal costs were limited during the 2-year follow-up interval. The LVA group acquired slightly more QALYs. From a societal perspective, LVA combined with CDT has the potential to be cost-effective, particularly when performed under local anaesthesia. REGISTRATION NUMBER: NCT02790021 (http://www.clinicaltrials.gov).