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The Brescia Internationally Validated European Guidelines on Minimally Invasive Pancreatic Surgery (EGUMIPS)

Ann Surg. 2023 Jul 14. doi: 10.1097/SLA.0000000000006006. Online ahead of print.

ABSTRACT

OBJECTIVE: To develop and update evidence- and consensus-based guidelines on laparoscopic and robotic pancreatic surgery.

SUMMARY BACKGROUND DATA: Minimally invasive pancreatic surgery (MIPS), including laparoscopic and robotic surgery, is complex and technically demanding. Minimizing the risk for patients requires stringent, evidence-based guidelines. Since the International Miami Guidelines on MIPS in 2019, new developments and key publications have been reported, necessitating an update.

METHODS: Evidence-based guidelines on 22 topics in 8 domains were proposed: terminology, indications, patients, procedures, surgical techniques and instrumentation, assessment tools, implementation and training, and artificial intelligence. The Brescia Internationally Validated European Guidelines on Minimally Invasive Pancreatic Surgery (EGUMIPS, September 2022) used the Scottish Intercollegiate Guidelines Network (SIGN) methodology to assess the evidence and develop guideline recommendations, the Delphi method to establish consensus on the recommendations among the Expert Committee, the AGREE II-GRS tool for methodological guideline quality assessment, and external validation by a Validation Committee.

RESULTS: Overall, 27 European experts, 6 international experts, 22 international Validation Committee members, 11 Jury Committee members, 18 Research Committee members, and 121 registered attendees of the two-day meeting were involved in the development and validation of the guidelines. In total, 98 recommendations were developed, including 33 on laparoscopic, 34 on robotic and 31 on general MIPS covering 22 topics in 8 domains. Out of 98 recommendations, 97 reached at least 80% consensus among the experts and congress attendees, and all recommendations were externally validated by the Validation Committee.

CONCLUSIONS: The EGUMIPS evidence-based guidelines on laparoscopic and robotic MIPS can be applied in current clinical practice to provide guidance to patients, surgeons, policy-makers and medical societies.

PMID:37450702 | DOI:10.1097/SLA.0000000000006006

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Discordance in TME Specimen Grading in a Prospective Phase II Multicenter Rectal Cancer Trial: Are We Overestimating the Quality of our Resections ?

Ann Surg. 2023 Jul 17. doi: 10.1097/SLA.0000000000005948. Online ahead of print.

ABSTRACT

OBJECTIVES: To report the results of a rigorous quality control (QC) process in the grading of total mesorectal excision (TME) specimens during a multicenter prospective phase II trial of transanal TME.

SUMMARY BACKGROUND DATA: Grading of TME specimens is based on macroscopic assessment of the mesorectum and standardized through synoptic pathology reporting. TME grade is a strong predictor of outcomes with incomplete (IC) TME associated with increased rates of local recurrence relative to complete or near complete (C/NC) TME. Although TME grade serves as an endpoint in most rectal cancer trials, in protocols incorporating centralized review of TME specimens for quality assurance, discordance in grading and the management thereof has not been previously described.

METHODS: A phase II prospective taTME trial was conducted from 2017-2022 across 11 North American centers with TME quality as primary study endpoint. QC measures included training of site pathologists in TME protocols, (2) blinded grading of de-identified TME specimen photographs by central pathologists, and (3) reconciliation of major discordance prior to trial reporting. Cohen’s Kappa statistic was used to assess agreement in grading.

RESULTS: Overall agreement in grading of 100 TME specimens between site and central reviewer was rated as fair, (κ=0.35 (95% CI, 0.10-0.61, P<0.0001). Concordance was noted in 54%, with minor and major discordance in 32% and 14% of cases respectively. Upon reconciliation, 13/14 (93%) major discordances were resolved. Pre- versus post-reconciliation rates of C/NC and IC TME are 77%/16% and 7% versus 69%/21% and 10%. Reconciliation resulted in a major upgrade (IC to NC, N=1) or major downgrade (NC/C to IC, N=4) in 5 cases overall (5%).

CONCLUSIONS: A 14% rate of major discordance was observed in TME grading between site and central reviewers. Resolution resulted in a major change in final TME grade in 5% of cases, which suggests that reported rates or TME completeness are likely overestimated in trials. QC through central review of TME photographs and reconciliation of major discordances is strongly recommended.

PMID:37450694 | DOI:10.1097/SLA.0000000000005948

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Facial Mucosal Level Change Following Maxillary Anterior Single Immediate Tooth Replacement in Extraction Sockets With Facial Bone Wall Defects: A 4- to 15-Year Retrospective Study

Compend Contin Educ Dent. 2023 Jul-Aug;44(7):392-401.

ABSTRACT

An intact extraction socket has been considered a prerequisite for an immediate implant placement and provisionalization (IIPP) procedure. Recent studies, however, have shown successful outcomes when IIPP was performed in sockets with a facial bone wall defect. This retrospective study evaluated the facial implant mucosal stability following IIPP in extraction sockets with a facial bone wall defect in the esthetic zone. The study included 16 cases in 16 patients who received maxillary anterior single IIPP with contour bone graft (C-BG) and contour connective tissue graft (C-CTG) in compromised extraction sockets (V- or U-shaped defect). After a mean follow-up of 6 years, the implant success rate was 100% (16/16). Minimal and non-statistically significant changes were noted in the facial implant mucosal and marginal bone level. Statistically significant changes were observed in facial implant mucosal thickness gain (2.5 mm [1.8 mm to 3.5 mm]) and midfacial bone sounding reduction (6 mm). Within the confines of this study, IIPP with simultaneous C-BG and C-CTG in fresh extraction sockets exhibiting a V- or U-shaped facial bone wall defect can lead to long-term successful outcomes in terms of mucosal stability, contour bone gain, and marginal bone level stability.

PMID:37450677

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Pudendal Nerve Block With Liposomal Bupivacaine for Sacrospinous Ligament Suspension

Urogynecology (Phila). 2023 Jul 13. doi: 10.1097/SPV.0000000000001397. Online ahead of print.

ABSTRACT

IMPORTANCE: Pudendal nerve block has been frequently used as a pain management modality for vaginal prolapse surgery. However, studies investigating its efficacy and the type of anesthetic used have had conflicting results.

OBJECTIVE: This study aimed to evaluate the effect of intraoperative pudendal nerve block with liposomal bupivacaine on postoperative pain after sacrospinous ligament suspension surgery.

STUDY DESIGN: In this single-blinded randomized controlled trial, 83 women undergoing sacrospinous ligament suspension were randomized to receive either intraoperative pudendal nerve block with liposomal bupivacaine or no block. Participants recorded their pain level on postoperative days (PODs) 1-3 and 7, the number of pain medication pills consumed, and the quality of their recovery using a validated questionnaire.

RESULTS: There were no significant differences in pain scores between the groups on POD 1 and POD 3: 5 (2-6.25) versus 5.5 (4-8; P = 0.058) and 4 (1-6) versus 5 (2-7; P = 0.146), respectively. On POD 2, the overall pain score was statistically different between the groups, with the block group having lower interquartile ranges. This difference, however, was not clinically significant: 5 (1.75-5) versus 5 (3.25-7.75; P = 0.023). In the subset of participants who underwent a concomitant midurethral sling procedure, POD 2 and POD3 pain scores were significantly lower in those who received the block: 3 (1-5) versus 6 (5-8; P = 0.006) for POD 2 and 3 (1-5) versus 5 (3.250-7; P = 0.042) for POD 3. There were no significant differences in pain medication consumption or the quality of recovery scores.

CONCLUSION: Pudendal nerve block with liposomal bupivacaine did not result in significant differences in postoperative pain after sacrospinous ligament suspension, except in those participants who underwent a concomitant midurethral sling procedure.

PMID:37450670 | DOI:10.1097/SPV.0000000000001397

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Liver transplantation with uncontrolled versus controlled DCD donors using normothermic regional perfusion and ex-situ machine perfusion

Liver Transpl. 2023 Jul 17. doi: 10.1097/LVT.0000000000000219. Online ahead of print.

ABSTRACT

BACKGROUND: In Italy, 20 minutes of continuous, flat-line electrocardiogram are required for death declaration, which significantly increase the risks of DCD LT. Despite prolonged warm ischemia time, Italian centers reported good outcomes in controlled DCD (cDCD) LT by combining normothermic regional and end-ischemic machine perfusion. However, data on uncontrolled DCD (uDCD) LT performed by this approach are lacking.

PATIENTS AND METHODS: This was a multicenter, retrospective study performed at three large volume centers comparing clinical outcomes of uncontrolled versus controlled DCD LT. The aim of the study was to assess outcomes of sequential normothermic regional perfusion (NRP) and end-ischemic machine perfusion in uncontrolled DCD liver transplantation (LT) Results: Of 153 DCD donors evaluated during study period, 40 uDCD and 59 cDCD grafts were transplanted (utilization rate 52% vs. 78%, p = 0.004). Recipients of uDCD grafts had higher MEAF (4.9 vs. 3.5, p < 0.001) and CCI score at discharge (24.4 vs. 8.7, p = 0.026), longer ICU stay (5 vs. 4 d, p = 0.047) and a trend towards more severe AKI. At multivariate analysis, 90-days graft loss was associated with recipient BMI and lactate downtrend during NRP. One-year graft survival was lower in uDCD (75% vs. 90%, p = 0.007) but became comparable when non-liver-related graft losses were treated as censors (77% vs. 90%, p = 0.100). Incidence of ischemic cholangiopathy was 10% in uDCD versus 3% in cDCD, p = 0.356.

CONCLUSIONS: uDCD LT with prolonged warm ischemia is feasible by the sequential use of NRP and end-ischemic machine perfusion. Proper donor and recipient selection are key in achieving good outcomes in this setting.

PMID:37450659 | DOI:10.1097/LVT.0000000000000219

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Acceptability for the influenza virus vector COVID-19 vaccine for intranasal spray: A cross-sectional survey in Beijing, China

Hum Vaccin Immunother. 2023 Aug 1;19(2):2235963. doi: 10.1080/21645515.2023.2235963.

ABSTRACT

The intranasal spray COVID-19 vaccine was made available for the first time in China, it is necessary to understand receivers’ satisfaction and experience toward the vaccine to help optimize vaccination service. A self-administered multicenter cross-sectional questionnaire survey was conducted in Beijing, China, in December 2022. The vaccination experience was evaluated through three dimensions: immediate tolerance, smooth progress, and time-saving. Vaccine acceptability was measured by receivers’ preference for the intranasal spray over intramuscular injection after vaccination and their recommendation willingness. Stepwise multinomial and binary logistic regression models were applied to investigate factors associated with vaccine acceptability. Among 10,452 participants included in the analysis, 92.6% felt no discomfort during the inoculation, 99.8% thought the vaccination process went well, and 89.4% deemed it a time-saving option. For vaccine acceptability, 5566 (53.3%) participants were willing to recommend the vaccine to others, 534 (5.1%) refused, and 4352 (41.6%) had not decided yet; 6142 (58.8%) participants preferred the intranasal spray, 873 (8.4%) preferred the intramuscular injection, and 3437 (32.9%) had no preferences. The most concerned aspects of the intranasal spray vaccine were vaccine effectiveness and safety. Receivers who perceived higher vaccine effectiveness or safety were more likely to recommend it to others (OR, 95%CI: 4.41, 3.24-6.00; 6.11, 4.52-8.27) or prefer it over intramuscular injection after vaccination (OR, 95%CI: 5.94, 4.62-7.65; 8.50, 6.70-10.78). Receivers showed good acceptability and experience toward the intranasal spray COVID-19 vaccine. Vaccine effectiveness and safety were the most concerned aspects, and corresponding publicity and education efforts may help improve vaccine acceptability.

PMID:37450312 | DOI:10.1080/21645515.2023.2235963

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Evaluation and Forecasting Analysis of the Association of Conditional Cash Transfer With Child Mortality in Latin America, 2000-2030

JAMA Netw Open. 2023 Jul 3;6(7):e2323489. doi: 10.1001/jamanetworkopen.2023.23489.

ABSTRACT

IMPORTANCE: Latin America has implemented the world’s largest and most consolidated conditional cash transfer (CCT) programs during the last 2 decades. As a consequence of the COVID-19 pandemic, poverty rates have markedly increased, and a large number of newly low-income individuals, especially children, have been left unprotected.

OBJECTIVE: To evaluate the association of CCT programs with child health in Latin American countries during the last 2 decades and forecast child mortality trends up to 2030 according to CCT alternative implementation options.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used a multicountry, longitudinal, ecological design with multivariable negative binomial regression models, which were adjusted for all relevant demographic, socioeconomic, and health care variables, integrating the retrospective impact evaluations from January 1, 2000, to December 31, 2019, with dynamic microsimulation models to forecast potential child mortality scenarios up to 2030. The study cohort included 4882 municipalities from Brazil, Ecuador, and Mexico with adequate quality of civil registration and vital statistics according to a validated multidimensional criterion. Data analysis was performed from September 2022 to February 2023.

EXPOSURE: Conditional cash transfer coverage of the target (lowest-income) population categorized into 4 levels: low (0%-29.9%), intermediate (30.0%-69.9%), high (70.0%-99.9%), and consolidated (≥100%).

MAIN OUTCOMES AND MEASURES: The main outcomes were mortality rates for those younger than 5 years and hospitalization rates (per 1000 live births), overall and by poverty-related causes (diarrheal, malnutrition, tuberculosis, malaria, lower respiratory tract infections, and HIV/AIDS), and the mortality rates for those younger than 5 years by age groups, namely, neonatal (0-28 days), postneonatal (28 days to 1 year), infant (<1 year), and toddler (1-4 years).

RESULTS: The retrospective analysis included 4882 municipalities. During the study period of January 1, 2000, to December 31, 2019, mortality in Brazil, Ecuador, and Mexico decreased by 7.8% in children and 6.5% in infants, and an increase in coverage of CCT programs of 76.8% was observed in these Latin American countries. Conditional cash transfer programs were associated with significant reductions of mortality rates in those younger than 5 years (rate ratio [RR], 0.76; 95% CI, 0.75-0.76), having prevented 738 919 (95% CI, 695 641-782 104) child deaths during this period. The association of highest coverage of CCT programs was stronger with poverty-related diseases, such as malnutrition (RR, 0.33; 95% CI, 0.31-0.35), diarrhea (RR, 0.41; 95% CI, 0.40-0.43), lower respiratory tract infections (RR, 0.66, 95% CI, 0.65-0.68), malaria (RR, 0.76; 95% CI, 0.63-0.93), tuberculosis (RR, 0.62; 95% CI, 0.48-0.79), and HIV/AIDS (RR, 0.32; 95% CI, 0.28-0.37). Several sensitivity and triangulation analyses confirmed the robustness of the results. Considering a scenario of moderate economic crisis, a mitigation strategy that will increase the coverage of CCTs to protect those newly in poverty could reduce the mortality rate for those younger than 5 years by up to 17% (RR, 0.83; 95% CI, 0.80-0.85) and prevent 153 601 (95% CI, 127 441-180 600) child deaths by 2030 in Brazil, Ecuador, and Mexico.

CONCLUSIONS AND RELEVANCE: The results of this cohort study suggest that the expansion of CCT programs could strongly reduce childhood hospitalization and mortality in Latin America and should be considered an effective strategy to mitigate the health impact of the current global economic crisis in low- and middle-income countries.

PMID:37450301 | DOI:10.1001/jamanetworkopen.2023.23489

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Lifestyle Enrichment in Later Life and Its Association With Dementia Risk

JAMA Netw Open. 2023 Jul 3;6(7):e2323690. doi: 10.1001/jamanetworkopen.2023.23690.

ABSTRACT

IMPORTANCE: Lifestyles enriched with socially and mentally stimulating activities in older age may help build cognitive reserve and reduce dementia risk.

OBJECTIVE: To investigate the association of leisure activities and social networks with dementia risk among older individuals.

DESIGN, SETTING, AND PARTICIPANTS: This longitudinal prospective cohort study used population-based data from the ASPREE Longitudinal Study of Older Persons (ALSOP) for March 1, 2010, to November 30, 2020. Community-dwelling individuals in Australia aged 70 years or older who were generally healthy and without major cognitive impairment at enrollment were recruited to the ALSOP study between March 1, 2010, and December 31, 2014. Data were analyzed from December 1, 2022, to March 31, 2023.

EXPOSURES: A total of 19 measures of leisure activities and social networks assessed at baseline were classified using exploratory factor analysis.

MAIN OUTCOMES AND MEASURES: Dementia was adjudicated by an international expert panel according to Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria. Cox proportional hazards regression examined dementia risk over 10 years, adjusting for education, socioeconomic status, and a range of health-related factors.

RESULTS: This study included 10 318 participants. Their median age was 73.8 (IQR, 71.6-77.2) years at baseline, more than half (52.6%) were women, and most self-identified as White (98.0%). In adusted analyses, more frequent engagement in adult literacy activities (eg, writing letters or journaling, using a computer, and taking education classes) and in active mental activities (eg, playing games, cards, or chess and doing crosswords or puzzles) was associated with an 11.0% (adjusted hazard ratio [AHR], 0.89 [95% CI, 0.85-0.93]) and a 9.0% (AHR, 0.91 [95% CI, 0.87-0.95]) lower risk of dementia, respectively. To a lesser extent, engagement in creative artistic activities (craftwork, woodwork, or metalwork and painting or drawing) (AHR, 0.93 [95% CI, 0.88-0.99]) and in passive mental activities (reading books, newspapers, or magazines; watching television; and listening to music or the radio) (AHR, 0.93 [95% CI, 0.86-0.99]) was also associated with reduced dementia risk. In contrast, interpersonal networks, social activities, and external outings were not associated with dementia risk in this sample.

CONCLUSIONS AND RELEVANCE: These results suggest that engagement in adult literacy, creative art, and active and passive mental activities may help reduce dementia risk in late life. In addition, these findings may guide policies for geriatric care and interventions targeting dementia prevention for older adults.

PMID:37450299 | DOI:10.1001/jamanetworkopen.2023.23690

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Clonal diversity and zoonotic potential of MDR Escherichia coli isolated from poultry at different age intervals

Br Poult Sci. 2023 Jul 14. doi: 10.1080/00071668.2023.2236038. Online ahead of print.

ABSTRACT

1. A pool of 480 E. coli isolates of poultry (broilers and ducks) representing different time intervals (0, 10, 20 and 30 days) was selected for ribotyping and used to determine polymorphism of 16-23S ribosomal RNA intergenic space. All the isolates were multidrug-resistant (MDR).2. Out of these, 10 isolates were tested for MLST (MultiLocus Sequence Typing) among which novel allelic combinations and therefore new sequence types were identified in seven isolates.3. This work showed the changes in E. coli strains structure at farm level and individual bird level in host species raised on organised farms with similar parental lineage and environmental housing. The statistical results showed that the structure of variation is very different by farm, supporting a strong effect of location, which confirms the temporal clustering.4. There were significant differences between E. coli strains in chickens and ducks, indicating host specificity of the E. coli strains.5. Some of the pathogenic E. coli strains found using MLST belonged to ST735, ST2796 and a pandemic clone ST752 of ST10 clonal complex. The results strongly suggested the clonal expansion and establishment of specific MDR clones that have zoonotic relevance.

PMID:37450277 | DOI:10.1080/00071668.2023.2236038

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Myomectomy in adult women of reproductive age: a propensity score-matched study for pregnancy rates

Arch Gynecol Obstet. 2023 Jul 14. doi: 10.1007/s00404-023-07135-0. Online ahead of print.

ABSTRACT

PURPOSE: To study whether it is better to perform or not a myomectomy, in terms of surgical and reproductive outcomes in patients of advanced reproductive age, by an observational prospective study in university-affiliated and Community Hospitals.

MATERIALS AND METHODS: 40 years and older patients affected by non-submucous symptomatic uterine fibroids and desiring future fertility were enrolled and treated by laparoscopic intracapsular myomectomy by (LIM) or by open laparotomy (OIM), or by a non-surgical management as control group, while attempting to conceive. The primary outcome measures were fibroid characteristics, pre- and post-surgical parameters, pregnancy achievement; the secondary outcome measures were the spontaneous or ART pregnancy outcomes, eventual week of abortion and type of delivery. Propensity scores have been calculated with logistic regression for binary and continuous variables.

RESULTS: 202 patients completed the study: 112 operated by LIM, 40 by OIM and 50 patients as control group. Patients undergoing OIM have a worse surgical outcome than LIM. No difference was seen in pregnancy either after myomectomy or control group during follow-up. In the LIM group, there were 44 pregnancies (39.2%), and in the OIM group, there were 9 (22.5%) and 16 in the control group (32%). The weeks of delivery were statistically greater for the control group versus the surgical groups, with no difference in Apgar score between the 3 groups.

CONCLUSION: Patients aged over 40 years did not show substantial differences in reproductive outcome, whether operated or not. Myomectomy in over 40-year-old patients has no detrimental effect on future pregnancy rates and over when compared to expectant management.

PMID:37450263 | DOI:10.1007/s00404-023-07135-0