BACKGROUND: Boerhaave syndrome is defined as a spontaneous perforation of the oesophagus. The mainstay of treatment is resuscitation of the patient, closure of the oesophageal defect, and drainage of perioesophageal and...BACKGROUND: Boerhaave syndrome is defined as a spontaneous perforation of the oesophagus. The mainstay of treatment is resuscitation of the patient, closure of the oesophageal defect, and drainage of perioesophageal and pleural fluid collections. Whether the optimal approach is endoscopic, surgical, or conservative management remains unknown and there are no clear guidelines. The aim of this multicentre retrospective cohort study was to evaluate current treatment strategies and outcomes for Boerhaave syndrome. METHODS: A multicentre retrospective analysis of data from 23 participating European tertiary centres was performed. Patients with Boerhaave syndrome treated between January 2019 and December 2023 were eligible for inclusion. The primary endpoint was the length of ICU stay and secondary endpoints included in-hospital mortality, 90-day mortality, and the length of overall hospital stay. RESULTS: In total, 216 patients were included; 151 were men (70%), the median age was 62 (22-95) years, and 81 (40%) were treated >24 h after the start of symptoms. Seventy (32%) patients were managed endoscopically (group I), 73 (34%) were managed surgically (group II), 67 (31%) were managed using a combination of endoscopy and surgery (group III), and 6 (3%) were managed using other methods (group IV). For patients in groups I-III: the median length of ICU stay was 8 (0-67) days, with no differences between the three groups (P = 0.105); the in-hospital mortality rate and 90-day mortality rate were both 12% (P = 0.490 and P = 0.637, respectively); and the median length of overall hospital stay was 27 (range 1-193) days, with the longest stays observed in patients who received combined treatment (P = 0.032). CONCLUSION: This study provides a comprehensive overview of the current treatment strategies and outcomes for patients with Boerhaave syndrome in Europe.
BACKGROUND: Magnetic seeds have comparable performance to guidewires in breast lesion localization with the advantages of shorter operating time, facilitated logistics, and higher staff satisfaction. However, the high co...BACKGROUND: Magnetic seeds have comparable performance to guidewires in breast lesion localization with the advantages of shorter operating time, facilitated logistics, and higher staff satisfaction. However, the high cost of the device remains a concern and warrants health economic evaluation. METHODS: This is a predefined health economic analysis of a pragmatic RCT including 426 patients (median age of 65 (interquartile range (i.q.r.) 56-71) years, median BMI of 26.6 (i.q.r. 24.0-29.8) kg/m2, and a median tumour size of 11 (i.q.r. 8-15) mm) with non-palpable breast cancer, randomized to localization of the tumour with either a magnetic seed or a guidewire. Sentinel lymph node detection was performed using superparamagnetic iron oxide nanoparticles, enabling a totally magnetic approach. A cost-minimization analysis was conducted, from a healthcare system perspective, using unadjusted and adjusted analyses of costs. RESULTS: The unadjusted analysis did not show any difference in incremental costs (guidewire €3337 versus magnetic seed €3274; difference -€63 (95% c.i. -€302 to €174); P = 0.599). The adjusted analysis, including marker, type of breast surgery performed, and single-session lesion and SLN localization, showed that the magnetic seed was associated with reduced costs (guidewire €3514 versus magnetic seed €3123; difference -€391 (95% c.i. -€422 to -€360); P = 0.002), corresponding to a 11.1% reduction. Sensitivity analyses did not change direction of outcome. CONCLUSION: In this predefined health economic analysis of an RCT, the use of magnetic seeds resulted in incremental cost containment, despite the increased cost of the device. Contributing factors included shorter localization time, shorter operating time, and process streamlining.
BACKGROUND: Risk assessment plays an important role in surgical decision-making. To estimate complication risk, many surgeons rely on gestalt, a mental process that involves integrating a range of clinical information. O...BACKGROUND: Risk assessment plays an important role in surgical decision-making. To estimate complication risk, many surgeons rely on gestalt, a mental process that involves integrating a range of clinical information. Others utilize dedicated risk scoring tools, which offer more standardized assessments. The aims of this systematic review were to explore the current evidence on the predictive value of gestalt for adverse postoperative events and to compare gestalt prediction with various scoring tools. METHODS: This systematic review was conducted following the PRISMA 2020 guidelines and the Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy. MEDLINE, Embase, Scopus, ClinicalTrials.gov, ACM digital library, and IEEE Xplore databases were searched. Studies concerned with surgeon gestalt prediction of adverse postoperative outcomes were included. Risk of bias was assessed using the QUADAS-2 tool. Outcomes evaluated were gestalt and scoring tool predictive accuracies for mortality and morbidity. A narrative synthesis was conducted. RESULTS: A total of 34 studies encompassing 33 657 patients were included. Surgeons had good discrimination when predicting mortality, but consistently overestimated risk. Scoring tools generally outperformed surgeons, but integrated tools incorporating both gestalt and scoring tool outputs performed best. There was some evidence that gestalt accuracy improved with surgeon experience. Surgeons may also be better at predicting complications for elective procedures compared with emergency procedures. CONCLUSION: Surgeon gestalt can be a valuable predictor of surgical outcomes both on its own and as a component of integrated risk scoring tools. Future studies should aim to elucidate what factors contribute to effective gestalt assessment.
BACKGROUND: The benefit of closed incision negative-pressure therapy (ciNPT) after open incisional hernia repair in reducing surgical-site infection (SSI) is uncertain. METHODS: The PROPRESS multicentre RCT was conducted...BACKGROUND: The benefit of closed incision negative-pressure therapy (ciNPT) after open incisional hernia repair in reducing surgical-site infection (SSI) is uncertain. METHODS: The PROPRESS multicentre RCT was conducted from 1 March 2023 to 25 June 2024 at three Danish hospitals. Patients undergoing elective open incisional hernia repair were randomized to ciNPT or a standard wound dressing (SWD). The primary outcome was the incidence of SSI at 30 days. Secondary outcomes at 30 days included the pooled incidence of surgical-site occurrences (SSOs), patient-reported quality of life (QoL), and patient-reported scar assessment. The last follow-up date was 25 July 2024. RESULTS: A total of 110 patients were randomized (54 SWD patients and 56 ciNPT patients; median age of 63.9 (interquartile range 50.7-69.0) years; 45 (40.1%) were female) and 108 (98.2%) completed follow-up at 30 days. In total, 7 of the 110 patients (6.4%) were smokers, the mean(s.d.) BMI was 29.3(4.1) kg/m2, and the mean(s.d.) horizontal defect size was 8.7(4.7) cm. One death in each group was unrelated to the intervention, but surgery and anaesthesia may have been predisposing factors for mortality. There was no difference in SSI rates; 4 of 53 patients (8%) in the SWD group versus 7 of 55 patients (13%) in the ciNPT group (P = 0.673). With regard to SSOs, these affected 12 of 53 patients (23%) in the SWD group versus 14 of 55 patients (26%) in the ciNPT group (P = 0.907). There was no difference in scar scores (equal mean scores of 24; P = 0.892) and overall QoL improved significantly (mean score difference: -12.8 (95% c.i. -15.4 to -10.2); P < 0.001) without a difference between the groups (mean score change: SWD -12.6 versus ciNPT -13.0; P = 0.874). CONCLUSION: ciNPT did not reduce SSI after open incisional hernia repair in this RCT, which was limited by the relatively small number of patients. REGISTRATION NUMBER: NCT05050786 (http://www.clinicaltrials.gov).
Menso JE, Bruna CL, Ali M
… +30 more, Bonsing B, Bosscha K, Brosens LAA, Busch OR, Crobach ASLP, Daams F, Derksen W, Dewulf MJL, Doukas M, Fariña Sarasqueta A, Festen S, Abu Hilal M, de Hingh IHJT, Homs MYV, Kazemier G, Lips DJ, Luyer MDP, de Meijer VE, Mieog JSD, Te Riele WW, van Santvoort HC, van der Schelling GP, Stommel M, Verheij J, de Wilde RF, Wilmink JW, Molenaar IQ, Groot Koerkamp B, van der Geest LG, Besselink MG
BACKGROUND: Robot-assisted pancreatoduodenectomy (RPD) aims to enhance postoperative recovery compared to open pancreatoduodenectomy (OPD). Although recent randomized trials confirmed the short-term safety of RPD, they d...BACKGROUND: Robot-assisted pancreatoduodenectomy (RPD) aims to enhance postoperative recovery compared to open pancreatoduodenectomy (OPD). Although recent randomized trials confirmed the short-term safety of RPD, they did not confirm superiority or assess oncological safety. This nationwide observational cohort study compares oncological outcome after RPD versus OPD in patients with resectable pancreatic ductal adenocarcinoma (PDAC) and distal cholangiocarcinoma (DCC) without vascular contact. METHODS: All consecutive patients undergoing RPD and OPD for upfront resectable PDAC and DCC without vascular contact on preoperative imaging in the Netherlands were included. Data were obtained from the Netherlands Cancer Registry (2016-2023). Primary outcomes were overall survival (OS) and R0-resection rate. RESULTS: Overall, 1675 patients after pancreatoduodenectomy for upfront resectable PDAC and DCC were included (375 RPD; 1300 OPD). Adjusted median OS was 23 months after RPD versus 22 months after OPD, with comparable 5-year survival rate (23.3% versus 22.4%, HR 0.96 [0.82-1.14], P = 0.665). The R0-resection rate was comparable (57.1% versus 59.7%, P = 0.368). RPD was associated with a shorter hospital stay (median 9 versus 11 days, P < 0.001) and comparable in-hospital/30-day (3.1% versus 2.6%, P = 0.618) and 90-day mortality rate (7.7% versus 6.2%, P = 0.276). In patients with PDAC, no differences in receipt (58.2% versus 58.7%, P = 0.900), time to start (median 54 versus 58 days, P = 0.107), or completion of adjuvant chemotherapy (30.4% versus 30.4%, P = 0.999) were observed. CONCLUSIONS: In this nationwide study, oncological outcome including 5-year survival was comparable between patients undergoing RPD and OPD for upfront resectable PDAC and DCC without vascular contact without differences in the use of adjuvant therapy for PDAC.
BACKGROUND: Rectus diastasis (RD) can cause functional impairment and pain. Surgical approaches vary regarding mesh use for linea alba restoration. The aim of this RCT was to compare plication supported by mesh (PSUM) wi...BACKGROUND: Rectus diastasis (RD) can cause functional impairment and pain. Surgical approaches vary regarding mesh use for linea alba restoration. The aim of this RCT was to compare plication supported by mesh (PSUM) with suture plication in patients with symptomatic postpartum RD. METHODS: This single-centre superiority double-blind RCT was conducted in Finland from April 2018 to November 2022. The pre-specified primary outcome was RD recurrence at 1 year (inter-rectus distance (IRD) >20 mm) and a post-hoc primary outcome was absolute reduction in IRD. Secondary outcomes included health-related quality of life (HRQoL), low back disability (Oswestry Disability Index (ODI)), motor control, and complications. The date of the last follow-up was 30 November 2022. RESULTS: In total, 86 normal-weight women (mean age of 38.7 (range 25-52) years) were randomized, with 84 patients (98%) available for follow-up (44 in the PSUM group and 40 in the suture plication group). At 1 year, there was no difference in RD recurrence between the PSUM group and the suture plication group (2 of 44 (5%) versus 2 of 40 (5%) respectively; P = 0.922). IRD reduction was greater in the PSUM group (52 (95% c.i. 48 to 56) mm) than in the suture plication group (44 (95% c.i. 40 to 47) mm) (P < 0.002). HRQoL, ODI, and enhanced performance test results all improved in both groups compared with baseline (P = 0.000-0.039). There was no difference in the complication rate between the PSUM group and the suture plication group (17 of 44 (39%) versus 13 of 40 (33%) respectively; P = 0.558). CONCLUSION: At 1 year, both PSUM and suture plication result in stable outcomes, with no difference in the RD recurrence rate, but the study was limited by both a small number of patients and a lower than anticipated overall RD recurrence rate. For the whole patient cohort, surgery was associated with improved motor control, low back function, and HRQoL compared with baseline. REGISTRATION NUMBER: NCT03509376 (http://www.clinicaltrials.gov).
González-Sagredo A, Gil Olaria M, D'Oria M
… +10 more, López-García P, Grando B, Gonzalo Villanueva B, Espinar Garcia E, Carnaval T, Llagostera S, Lepidi S, Vila R, Iborra E, Videla S
BACKGROUND: Surgical-site infection (SSI) is a relevant complication in vascular surgery due to its associated morbidity and mortality. However, the optimal type of skin closure (intradermal suture versus metallic staple...BACKGROUND: Surgical-site infection (SSI) is a relevant complication in vascular surgery due to its associated morbidity and mortality. However, the optimal type of skin closure (intradermal suture versus metallic staples) to minimize SSI rates has been scarcely studied. The aim of this study was to compare the incidence of SSI associated with intradermal suture versus metallic staples in patients undergoing arterial surgery through a groin femoral approach. METHODS: A multicentre, open-label, superiority RCT was conducted between April 2022 and January 2024 across three tertiary hospitals (two in Spain and one in Italy). The last-patient, last-visit date was 31 March 2024. Patients were randomized (1 : 1) to receive intradermal sutures (experimental group) or metallic staples (control group) via a computer-generated random sequence prepared by an independent researcher not involved in other aspects of the trial. The primary outcome was the 28-day cumulative incidence of SSI after elective revascularization procedures with inguinal vertical incisions with or without concomitant incisions, assessed per the definitions of the US Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network. RESULTS: In this trial, 112 patients were randomized to intradermal suture and 113 patients were randomized to metallic staples. SSIs occurred in eight patients in the intradermal suture group (cumulative incidence of 7.1% (95% c.i. 3.7% to 13.5%)) and six patients in the metallic staples group (cumulative incidence of 5.3% (95% c.i. 2.5% to 11.1%)). The relative risk (RR) of SSI was 1.4 (95% c.i. 0.5 to 3.8) times higher in the intradermal suture group, but the results were not statistically significant (P = 0.769). No additional SSIs occurred at 84 days after surgery, and the rates of lymphocele, haematoma, or lymphorrhoea did not differ significantly between groups. CONCLUSION: Intradermal sutures were not superior to metallic staples in preventing SSIs in patients undergoing vascular surgery through a groin femoral approach. REGISTRATION NUMBER: NCT05434182 (http://www.clinicaltrials.gov).
INTRODUCTION: In recent years there have been a plethora of new endovascular devices have entered the market, including paclitaxel (PTX) drug-coated balloons (DCB) and drug-eluting stents (DES) for treating patients with...INTRODUCTION: In recent years there have been a plethora of new endovascular devices have entered the market, including paclitaxel (PTX) drug-coated balloons (DCB) and drug-eluting stents (DES) for treating patients with chronic limb-threatening ischaemia (CLTI). There have been concerns that the use of PTX is associated with increased all-cause mortality rate in this patient population. METHODS: In the BASIL-3 trial (ISRCTN14469736) UK patients with CLTI were randomized (1:1:1) to receive femoro-popliteal (FP) plain balloon angioplasty (PBA; with or without bailout bare metal stenting (BMS), DCB angioplasty (DCBA) (with or without BMS), or primary DES. Here, data from the DCBA and DES arms have been pooled into a single 'drug technologies' (DT) group and compared with PBA ± BMS. The primary outcome was overall survival (OS). Secondary outcomes included amputation-free survival (AFS), major amputations, major adverse limb events, major adverse cardiovascular events, reinterventions, and 30-day mortality and morbidity rates. RESULTS: Four hundred and eighty-one participants were randomized (PBA: n = 160; DT: n = 321). At a median follow-up in survivors of 5.6 years, OS was similar between the pooled DT and PBA groups (adjusted hazard ratio (HR): 0.83; 95% c.i.: 0.64 to 1.07). There was no evidence of a statistically significant difference in AFS between the groups (adjusted HR: 0.84; 95% c.i.: 0.66 to 1.06), or other secondary outcomes. CONCLUSIONS: This further pooled analysis of the BASIL-3 RCT does not support the notion that the use of drug-eluting technologies, when compared to plain balloon angioplasty, increases all-cause mortality rate, or has other clinically important adverse effects, when used in patients with CLTI.
BACKGROUND: Sensory preservation of the nipple-areolar complex (NAC) is crucial for physical, psychological, and sexual health after mastectomy. Robotic-assisted nipple-sparing mastectomy (rNSM) techniques have shown pro...BACKGROUND: Sensory preservation of the nipple-areolar complex (NAC) is crucial for physical, psychological, and sexual health after mastectomy. Robotic-assisted nipple-sparing mastectomy (rNSM) techniques have shown promise in preserving NAC sensation, but there is limited detailed anatomical evidence supporting this observation. The aim of this study was to characterize the anatomical pathways and variability of sensory nerves innervating the NAC, particularly focusing on implications for the development of improved nerve-preserving techniques during breast surgery. METHODS: A cadaveric anatomical study on three adult female cadaveric donors (six breasts) was undertaken, which was complemented by a systematic review of the existing literature using a modified PRISMA approach. RESULTS: The anterior cutaneous branch (ACB) and the lateral cutaneous branch (LCB) of the fourth intercostal nerve (ICN) were consistently the primary cutaneous nerves innervating the NAC. The ACB of the fourth ICN, particularly its lateral division, followed a superficial and consistent subdermal route bypassing breast tissue in all cadavers. Conversely, the LCB of the fourth ICN, specifically its anterior division, traversed deeper breast tissue to reach the NAC. Variable supplementary contributions were observed from the second, third, and fifth ICNs, and previously undocumented ancillary branches. Significant inter-individual anatomical variability was noted. CONCLUSION: The consistent superficial pathway of the ACB of the fourth ICN provides a clear anatomical rationale for improved sensory preservation observed in rNSM, given the procedure's lateral incision and precise dissection capabilities. Recognition of anatomical variability and detailed nerve trajectories should guide surgical planning to optimize sensory outcomes in breast cancer surgery and reconstruction.
van Lieshout ML, Lemmens JMG, Greijdanus NG
… +20 more, Wienholts K, Ubels S, Talboom K, Hannink G, Wolthuis A, de Lacy FB, Lefevre JH, Solomon M, Frasson M, Rotholtz N, Denost Q, Perez RO, Konishi T, Panis Y, Rutegård M, Hompes R, van Workum F, Tanis PJ, de Wilt JHW, TENTACLE–Rectum Collaborative Group
BACKGROUND: People with multiple long-term conditions (MLTC) commonly undergo elective surgery, yet current pathways remain poorly equipped to meet their complex needs. These pathways present a unique, time-sensitive opp...BACKGROUND: People with multiple long-term conditions (MLTC) commonly undergo elective surgery, yet current pathways remain poorly equipped to meet their complex needs. These pathways present a unique, time-sensitive opportunity to act. The aim of this study was to co-design a feasible intervention that integrates MLTC care into surgical pathways. METHODS: This was a theory-informed mixed-methods co-design study (informed by the National Institute for Health and Care Research (NIHR)/Medical Research Council (MRC) complex intervention framework). Phase 1 involved contextual analysis of current UK pathways (pathway mapping, policy/guideline scan, and national survey) and phase 2 involved multidisciplinary stakeholder workshops to develop a Theory of Change. RESULTS: In phase 1, pathway mapping identified variation and delayed preassessment, resulting in a limited window to optimize chronic diseases. The scoping review found no UK guidance integrating MLTC into surgical pathways. In the survey (73 responses, 51 National Health Service (NHS) Trusts), few services screened at listing and structured pathways were uncommon. Only one-in-ten hospitals had an MLTC-specific care pathway for elective surgical patients, primarily focusing on diabetes or anaemia management. In phase 2, 21 stakeholders agreed upon a pragmatic intervention prioritized on four domains (diabetes, hypertension, weight management, and smoking cessation), with five intervention components: surgeon-led checklist-based early identification at listing; automated referral to primary care/specialist services; patient-activation materials; optimization during waiting time; and structured discharge communication. CONCLUSION: This study presents a co-designed model that shifts MLTC care upstream to the point of listing, offering the potential to improve short- and long-term health.