Multicenter Randomized Trial Research Articles

Ten-Year Outcome of a Randomized Trial: Cytoreduction and HIPEC with Mitomycin C Versus Oxaliplatin for Appendiceal Neoplasm with Peritoneal Dissemination.

Appendiceal cancer is a rare disease that has proven difficult to study in prospectively. Our initial reportof this trial showed minor hematologic toxicity with both mitomycin C and oxaliplatin and similar 3-year survival. We now report an update of the first prospective randomized trial for appendiceal cancer with 10-year follow up. Patients with mucinous appendiceal neoplasms and evidence of peritoneal dissemination were enrolled in the Multicenter Randomized Trial to evaluating HIPEC for 120min with oxaliplatin (200mg/M2) or mitomycin C (40mg). Overall survival and disease-free survival were calculated at 10 years and compared between the groups. A total of 121 patients were included in the study. The patients were 57% female, with a mean age of 55.3 years (range 22-82 years). The disease was low grade in 71% and high grade in 29%. The average peritoneal cancer index (PCI) score was 18 (SD 10) in the mitomycin C group and 17.9 (SD 9.4) in the oxaliplatin group (p = 0.94). The 10-year survival rate was 56.2% (SE 7.2) with mitomycin C and 47.5% (SE 8.4) with oxaliplatin, p = 0.83. The 10-year progression-free survival rate in the mitomycin C group was 45.2% (SE 8.4) compared with 50.4% (SE 6.7) in the oxaliplatin group, p = 0.95. Median survival was 9.1 years after HIPEC with oxaliplatin, and median not reached for the mitomycin C group (> 5.6years). Oxaliplatin and mitomycin C have similar long-term efficacy for hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with appendiceal neoplasms and peritoneal dissemination. Long-term survival is experienced by most patients after cytoreduction surgery (CRS) and HIPEC for appendiceal neoplasms.

Comment on “Long-Term Outcome of Immediate Versus Postponed Intervention in Patients With Infected Necrotizing Pancreatitis (POINTER)”: Multicenter Randomized Trial

Comment on “Long-Term Outcome of Immediate Versus Postponed Intervention in Patients With Infected Necrotizing Pancreatitis (POINTER)”: Multicenter Randomized Trial

Influence of the Olfatín Project on the reduction of pain related to intranasal influenza vaccination, as part of a school influenza vaccination program

PurposeTo evaluate the influence of viewing the Olfatín Project video on the assessment of school LAIV-associated pain in three and four-year-old children through the Wong Baker Faces® pain classification scale. Design and methodsA three-arm randomized multicenter clinical trial with a placebo control group was carried out. The main variable measured was pain, assessed through the score on the Wong Baker Faces® Pain Rating Scale. There were a total population of 4591 children three and four-year-olds (born in 2019 and 2020) and who attended the 1st and 2nd year of early childhood education. Before the school vaccination, researchers randomly assigned participant schools corresponding to each of the basic health areas to each of the three study groups: Olfatín's video viewing, a control video viewing not related to influenza and no video viewing. ResultsNo significant differences according to sex, age or the minor's grade according to the assigned intervention were detected. 72.3% of those vaccinated assigned a 0 from the Wong Baker Faces® scale: 75.4% of those who watched Olfatín's video, 68.3% for those in Drilo's group and 72.8% for those who didn't watch any video, but without significant differences (p = 0.08). There were no significant differences either stratifying by sex. ConclusionLAIV is a painless vaccine for children, which has to be taken into account by the health authorities when planning the pediatric influenza vaccination campaign. Practice implicationsOlfatín's cartoon video can be used by professionals to create a greater experience for children and therefore a better acceptance.

Effectiveness of a Sugar Consumption Prevention Program in the First Year of Life on the Occurrence of Early Childhood Caries: A Multicentric Randomized Trial in Brazil.

This study aims to investigate the effectiveness of a nutritional counseling program for mothers of newborns to prevent sugar consumption in the first year of the child's life on the occurrence of Early Childhood Caries (ECC). A multicentric randomized clinical trial (ClinicalTrials.gov NCT03841123) was conducted in three state capitals of Brazil (n=516). Mothers were randomly assigned to the intervention group (IG) or control group (CG) after delivery. The IG received face-to-face nutritional counseling based on UNICEF dietary guidelines, followed by monthly phone calls. The CG received standard counseling. Dietary intake was measured through structured questionnaires and 24-hour recalls at six and 12 months. Calibrated dentists performed a dental clinical examination for ECC diagnosis after the children completed their first year of life. The prevalence of ECC was 17.4% in the overall sample (49/290). The number of affected teeth ranged from 0 to 6 (mean 0.43). The IG had a 2.4 times probability of not consuming sugar in the first six months of the child's life (RR 2.44; 95% CI 1.18-5.00) and they had Fa significantly lower mean number of sweet items consumed at 12 months (p=0.016). No significant differences between groups were found concerning the occurrence of ECC (RR 1.33; 95% CI 0.79-2.25) or the number of teeth affected by caries (p=0.273). The intervention to prevent and reduce sugar intake in the first year of life was not effective at reducing the occurrence of early childhood caries or the number of teeth with carious lesions.

Thursday, July 11, 202410:30 AM - 11:30 AMPPP01 Presentation Time: 10:30 AM: Late Toxicity of Intermediate / High Risk Prostate Cancer Patients Treated within a Multicenter Randomized Trial Comparing External Beam Radiotherapy Alone with External Beam Radiotherapy Plus a Brachytherapy Boost

Thursday, July 11, 202410:30 AM - 11:30 AMPPP01 Presentation Time: 10:30 AM: Late Toxicity of Intermediate / High Risk Prostate Cancer Patients Treated within a Multicenter Randomized Trial Comparing External Beam Radiotherapy Alone with External Beam Radiotherapy Plus a Brachytherapy Boost

Pre-hospital transdermal glyceryl trinitrate for transient ischaemic attack: Data from the RIGHT-2 trial.

Ambulance trials assessing interventions in suspected stroke patients will recruit patients with currently active symptoms that will resolve into transient ischaemic attack (TIA). The safety and efficacy of glyceryl trinitrate (GTN) in the pre-specified subgroup of patients with TIA in the Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial 2 (RIGHT-2) was assessed. RIGHT-2 was a pre-hospital-initiated multicentre randomized sham-controlled blinded-endpoint trial that randomized patients with presumed ultra-acute stroke within 4 h of symptom onset to transdermal GTN or sham. Final diagnosis was determined by site investigators. The primary outcome was a shift in modified Rankin Scale (mRS) scores at 90 days analysed using ordinal logistic regression reported as adjusted common odds ratio with 95% confidence intervals (CIs). Secondary outcomes included death or dependence (mRS >2). In all, 109 of 1149 (9.5%) patients had a final diagnosis of TIA (GTN 57, sham 52) with mean age 73 (SD 13) years, 19 (17.4%) had pre-morbid mRS >2, and onset to randomization was 80 min (interquartile range 49, 105). GTN lowered blood pressure by 7.4/5.2 mmHg compared with sham by hospital arrival. At day 90, GTN had no effect on shift in mRS scores (common odds ratio for increased dependence 1.47, 95% CI 0.70-3.11) but was associated with increased death or dependence (mRS >2): GTN 29 (51.8%) versus sham 23 (46.9%), odds ratio 3.86 (95% CI 1.09-13.59). Pre-hospital ultra-acute transdermal GTN did not improve overall functional outcome in patients with investigator-diagnosed TIA compared with sham treatment.

Letter to the Editor Regarding “Randomized Trial of Augmented Pelvic Fixation in Patients Undergoing Thoracolumbar Fusion for Adult Spine Deformity: Initial Results from a Multicenter Randomized Trial”

Letter to the Editor Regarding “Randomized Trial of Augmented Pelvic Fixation in Patients Undergoing Thoracolumbar Fusion for Adult Spine Deformity: Initial Results from a Multicenter Randomized Trial”

In Reply to the Letter to the Editor Regarding “Randomized Trial of Augmented Pelvic Fixation in Patients Undergoing Thoracolumbar Fusion for Adult Spine Deformity: Initial Results from a Multicenter Randomized Trial”

In Reply to the Letter to the Editor Regarding “Randomized Trial of Augmented Pelvic Fixation in Patients Undergoing Thoracolumbar Fusion for Adult Spine Deformity: Initial Results from a Multicenter Randomized Trial”

Somatosensory and dynamic balance improvement in older adults with diabetic peripheral neuropathy through sensorimotor exercise: A multisite randomized controlled trial

PurposeTo examine the effect of the Feldenkrais method on lower legs and foot somatosensory postural control-related function, dynamic balance, fear of falling and quality of life in adults with diabetic polyneuropathy in the short and mid-term. MethodsA single-blinded, parallel, multicentric randomized control trial was conducted in two health hospitals. Subjects with diabetic polyneuropathy and older than 55 years with a history of falls or dynamic balance dysfunction were recruited from the hospital databases and randomly allocated to the experimental or control group. The experimental group received 16 sessions of sensorimotor training based on the Feldenkrais method. Both groups received diabetic foot care instructions. The results were measured at the 3 and 6-month follow-up periods. ResultsThe mean age was 70 ± 8. A total of 44 participants were enrolled in the study, and 27 completed the process. No adverse events were reported. After the intervention, significant somatosensory results were obtained (p < 0.001). The results of the Up and Go and POMA tests were significant after the intervention (p < 0.001) and during the 3-month follow-up period for POMA (p = 0.018). The fear of falling showed significant results at the 3-month follow-up period (p = 0.03), and the quality of life in all measurements. ConclusionsSignificant short-term effects were obtained on somatosensory postural control-related function, dynamic balance, and fear of falling. Significant short and mid-term effects were achieved on quality of life. Older adults with diabetic polyneuropathy, dynamic balance impairment, or a history of falls can improve their abilities through the Feldenkrais method. Trial registrationClinicaltrials.gov: NCT05262946.

Efficacy assessment of intravenous immunoglobulin for gastrointestinal involvement in systemic sclerosis using UCLA SCTC GIT: Case-based review.

To summarize the published evidence in the literature on the use of intravenous immunoglobulin in gastrointestinal tract involvement in systemic sclerosis patients and report the experience of our department. A systematic literature review was performed; and a literature search was conducted in MEDLINE and Embase until 1/5/2024, using the participants, intervention, comparator and outcomes framework. Only full-text articles involving systemic sclerosis adults, submitted to intravenous immunoglobulin (at least one administration) to treat primary gastrointestinal tract manifestations. The outcome was the University of California at Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 score to evaluate response to treatment. Two reviewers performed the assessment of data extraction and synthesis, independently. Four papers (two case reports and two retrospective studies) out of 35 references were included. In addition, we added two systemic sclerosis patients from our department in this review. In 25 systemic sclerosis patients, with various gastrointestinal tract manifestations, the intravenous immunoglobulin therapy was found to improve digestive tract symptoms in SSc patients, as shown by the decrease in the scores of University of California at Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0. No adverse events were reported, except for one case of low-grade fever post-administration. The results from this systematic literature review based on case series suggest that intravenous immunoglobulin may improve gastrointestinal tract symptoms assessed by the University of California at Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 scale, with only minor reported adverse events, suggestive of an acceptable safety profile. We believe that this systematic literature review will contribute to shed light on the efficacy and safety aspects of intravenous immunoglobulin treatment in the management of gastrointestinal tract symptoms; and multicenter randomized placebo-controlled trials are urgently needed to foster progress in this field.

A multicenter randomized control trial: Point-of-care syndromic assessment versus standard testing in urgent care center patients with acute respiratory illness.

Syndromic assessment with multiplex polymerase chain reaction (mPCR) testing in patients with acute respiratory illness (ARI) allows for simultaneous identification of multiple possible infectious etiologies. Point-of-care (POC) syndromic assessment can be conducted in a clinical setting, such as an urgent care center (UCC), without requiring certified laboratories. The primary objective of this study was to determine whether POC syndromic assessment improved patient satisfaction for patients seen at an UCC with ARI; secondary objectives included whether syndromic assessment reduced self-isolation time, increased diagnostic confidence, and reduced overall antibiotic utilization. We conducted an unblinded multicenter randomized controlled trial on UCC patients with an ARI. Patients were randomized to either SC (defined as standard UCC testing for ARI) or syndromic assessment with POC mPCR. Patients were surveyed for patient satisfaction, self-isolation plans, diagnostic confidence, and overall antibiotic utilization. Among the 360 patients enrolled, those in the syndromic assessment group were more satisfied with the time required to communicate the results (98.4%vs. 42.4%, p<0.001) on day of treatment, more likely to resume normal activities sooner (83.3%vs. 69.4%, p=0.039), and more confident in their illness cause (60.7%vs. 29.6%, p<0.001); however, the rate of antibiotic utilization did not differ (33.5%vs. 26%, p=1.0). In conclusion, our study provides evidence supporting the use of syndromic assessment in UCCs for ARI diagnosis, including patient-centered outcomes such as greater confidence in diagnosis and more efficient isolation strategies. This study did not show a difference in more clinically oriented outcomes, such as a change in antibiotic utilization. Future studies should identify clinical care pathways to improve antibiotic stewardship for likely viral syndromes and whether the increased initial cost of syndromic assessment is offset by the clinical benefits and subsequent cost savings.

Equal Treatment, Unequal Outcomes? Debunking the Racial Disparity in Renin Angiotensin Aldosterone System Inhibitor Associated Reduction in Heart Failure Hospitalizations

BackgroundRenin angiotensin aldosterone system inhibitors (RAASi) are a mainstay treatment in patients with heart failure with reduced ejection fraction (HFrEF) in part to prevent hospitalizations. However, whether RAAS inhibitors reduce the risk of hospitalization in Black patients is not entirely clear because enrollment of Black patients in previous clinical trials was low, and a previous meta-analysis showed a significant racial disparity: reduction in hospitalizations with an RAAS inhibitor in White patients but not Black patients. Previous studies relied on the use of self-identified race instead of genomic ancestry. Therefore, this study aimed to investigate the role of self-identified race and genomic ancestry in the racial disparity in RAAS inhibitor associated reductions in HFrEF hospitalizations. MethodsThe primary outcome was time to first heart failure hospitalization. A (de-identified) heart failure patient registry and data from the GUIDE-IT multi-center randomized control trial were analyzed with Cox proportional hazards models un/adjusted for clinical risk factors, death as a competing risk, and time-varying RAAS inhibitor exposure. The proportion of Yoruba African ancestry was quantified.. Analysis of self – identified race were performed in both the registry and GUIDE-IT. Analysis of genomic ancestry was only performed in the registry since this information was not available in GUIDE-IT. A fixed effect meta-analysis combined results of both the registry and GUIDE-IT for race. ResultsThe registry had 1010 total HFrEF patients (Black = 509 and White = 501) with 852 having ancestry quantification (>80% Yoruba African Ancestry = 381 and <5% Yoruba African Ancestry = 471). GUIDE-IT had 810 HFrEF patients (Black = 322 and White = 488). There was no significant difference in the association of RAAS inhibitor exposure with heart failure hospitalization by race (meta-analysis p-value for race*RAAS inhibitor exposure interaction = 0.49; Black patients HR [95% CI] for RAAS inhibitor exposure = 0.89 [0.64-1.23)] P = 0.47; White patients = 1.20 (0.83-1.75) P = 0.34). Results were similar when analyzed by ancestry (p-value for ancestry*RAAS inhibitor exposure interaction = 0.57; >80% Yoruba African Ancestry = 0.93 [0.51-1.69] P = 0.80; <5% Yoruba African Ancestry = 1.29 [0.57-2.92] P = 0.54). ConclusionsIn contrast to a previous meta-analysis, this more contemporary analysis of 2 HFrEF patient datasets demonstrates the absence of a racial disparity in RAAS inhibitor associated reductions in heart failure hospitalizations. The difference in this racial disparity over time may be due to improvements in background heart failure therapies, racial differences in healthcare usage, and the use of more advanced statistical approaches.

Results of the RE-DINO multicenter randomized trial on the repeated use of vaginal dinoprostone (Propess®) for labor induction in patients at term

BackgroundLabor is induced in over 25% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 hours, there is uncertainty about whether to administer a second dinoprostone pessary or to use oxytocin to induce labor in order to achieve a vaginal delivery. ObjectivesOur principal objective was to determine whether placement of a second Propess®, followed by oxytocin (Syntocinon®) if necessary, in pregnant women for whom the first Propess® failed to induce cervical ripening increases the vaginal delivery rate compared to direct oxytocin injection. The vaginal delivery rate was therefore the primary outcome. The secondary outcomes were the cervical ripening failure rate and maternal and fetal morbidity and mortality. Study DesignRE-DINO is a prospective, open-label, multicenter, randomized superiority trial with 2 parallel arms running in 7 French hospitals. Patients at > 37 weeks of gestation who had unfavorable cervical conditions (Bishop score < 6) 24 hours after placement of the first Propess® (vaginal patch featuring progressive continuous diffusion of 10 mg dinoprostone), with fetuses in cephalic presentation, were included. Results160 pregnant women were randomized, 80 patients in each group, from December 2016 through April 2022. Baseline characteristics such as age, BMI, maternal age at induction and Bishop score at induction were similar between both groups. Vaginal delivery occurred in 76.3% of cases in the 2nd Propess® group and 73.8% of cases in the Syntocinon® group (RR=1.03 [0.86; 1.24], p=.715). Although the cesarean section rate was similar in each group, there were significantly more cesarean sections for arrest of dilatation (52.6% vs 19%; p=.0262) in the Propess® group and a larger, borderline-significant difference in patients having operative vaginal delivery (24.6% vs 11.9%; p=.07) for abnormal fetal heart rate (80% vs 29%; p=.05). There was significantly more failure of cervical ripening in the Propess® group (57.1% vs 19%; RR=2.59 ; 95% CI [1.64; 4.11]; p<.0001) and the interval between study treatment and delivery was also significantly longer (28.1h vs 9,7h; p<.0001). There was a higher incidence of postpartum hemorrhage in the Propess® group, although this was not significant (11.3% vs 5% ; p=,15), but also more newborns with acidosis (39.3% vs 27.9% ; p=.18) or severe acidosis (8,6% vs 3.4% ; p=.27), more meconium fluid (11.3% vs 6.3% ; p=.26) and transferred to intensive care (5% vs 2.5% ; p=.68). ConclusionOur data showed no superiority of a second dinoprostone pessary over oxytocin in patients not responding to initial prostaglandins E2 maturation for labor induction. Repeated use of Propess® is not useful for induction of labor.

WP1.7 - A systematic review and a meta-analysis of randomised control trials of prophylactic ilioinguinal neurectomy versus ilioinguinal nerve preservation for open inguinal hernia repair

Abstract Objective The objective of this meta-analysis is to compare the outcomes of prophylactic ilioinguinal neurectomy versus ilioinguinal nerve preservation for open inguinal hernia repair. Methods Studies reporting the patient outcomes were selected from medical electronic databases and meta-analysis was conducted by following the guidelines of the Cochrane Collaboration using statistical software RevMan version 5. Results Seven studies on 1,333 patients reporting post-operative outcomes were included. In the random effect model analysis, the severe pain at the end of the follow-up period [odds ratio (OR) 0.45, 95%, CI (0.10, 2.08), Z = 1.03, p = 0.30] was similar in both the groups with high heterogeneity (Tau2 = 0.97; Chi2 = 4.45, df = 1 (P = 0.03; I2 = 78 %) among included studies. Hypoesthesia at 6-month follow-up period [odds ratio 1.00, 95%, CI (0.47, 2.15), Z = 0.00, p = 1.00] suggests comparable outcomes in both groups with no heterogeneity among the included studies. The absence of pain reported by patients at the 6-month follow-up period [odds ratio 0.96, 95%, CI (0.72, 1.27), Z = 0.28, P = 0.78] suggests comparable outcomes in both groups with no heterogeneity among the included studies. Conclusion Post-operative outcomes like chronic groin pain, hypoesthesia or no pain reported by patients were similar in both groups. There was a paucity of data, therefore a major multicentre randomised control trial is recommended to strengthen the findings of this meta-analysis.

ThP7.13 - A systematic review of the perioperative outcomes of surgical fixation versus conservative approach for severe rib fractures

Abstract Objective The objective of this meta-analysis is to compare the patient outcomes for severe rib fractures being managed by operative or non-operative treatment. Methods Studies reporting patient outcomes in patients undergoing surgical fixation or conservative approach were selected from medical electronic databases and meta-analysis was conducted by following the guidelines of the Cochrane Collaboration using statistical software RevMan version 5. Results Three studies on 258 patients reporting patient outcomes were included. In the random effect model analysis, the total hospital stay [mean difference -1.44, 95%, CI (-2.88, 0.00), Z = 1.96, p = 0.05] was comparable between the two groups with no heterogeneity among included studies. The intensive care stay [mean difference -2.36, 95%, CI (-5.92, 1.21), Z = 1.30, p = 0.20] and mortality [odds ratio 1.08, 95%, CI (0.11, 10.31), Z = 0.07, p = 0.94] was comparable between the two groups but with moderate heterogeneity among included studies. Pneumonia was more common in patients of the non-operative group [odds ratio 0.35, 95%, CI (0.15, 0.82), Z = 2.41, p = 0.02] with no heterogeneity among included studies. Conclusion Pneumonia was more common in patients in the patients managed with the conservative approach. Other patient outcomes were comparable between the two groups. Due to the paucity of data, multiple other crucial variables could not be assessed and a major multi-centre randomised control trial is needed to confirm the findings of this meta-analysis.

Associations between 6-minute walk distance and physiologic measures and clinical outcomes in myositis-associated interstitial lung disease.

The 6-min walk test (6MWT) is a simple test widely used to assess sub-maximal exercise capacity in chronic respiratory diseases. We explored the relationship of 6-min walk distance (6MWD) with measurements of physiological, clinical, radiographic measures in patients with myositis-associated interstitial lung disease (MA-ILD). We analyzed data from the Abatacept in Myositis Associated Interstitial lung disease (Attack My-ILD) study, a 48-week multicentre randomized trial of patients with anti-synthetase antibodies and active MA-ILD. 6MWD, forced vital capacity (FVC), diffusing capacity (DLCO), high resolution CT, and various physician/patient reported outcome measures were obtained during the trial. Spearman's correlations and repeated-measures analysis with linear mixed-effects models were used to estimate the associations between 6MWD and various physiologic, clinical and radiographic parameters both cross-sectionally and longitudinally. Twenty participants with a median age of 57, 55% male and 85% white were analyzed. Baseline 6MWD did not associate with baseline PFTs. Repeated-measures analysis showed 6MWD over time associated with FVC over time, but not with DLCO. 6MWD over time also correlated with UCSD dyspnea score, Borg scores, as well as global disease activity and muscle strength over time. Emotional role functioning, vitality, general health and physical functioning scores by short form 36 also correlated with 6MWD over time. : Exploratory work in a small cohort of MA-ILD demonstrated 6MWD over time associated with parallel changes in FVC and patient reported outcomes of dyspnea, but not with DLCO. Larger studies are needed to validate the reliability, responsiveness and utility of the 6MWT in MA-ILD. ClinicalTrials.gov, NCT03215927.

123 Green/grey spaces - What is the best urban setting to enhance physical activity? Preliminary findings of the Health Benefits of Outdoor Physical Activity (HOPA) study

Abstract Purpose Strategies aimed at increasing physical activity (PA) must be feasible and easy for participants to adhere to. Outdoor public spaces emerge as relevant venues due to their easy accessibility and lack of cost. However, it is not clear what kind of urban spaces (“nature-based” or “road/sidewalk-based”) contribute the most to increasing PA. This study seeks to investigate the effect of an outdoor intervention on enhancing PA levels and reducing sedentary time (SED) among inactive adults. Methods HOPA was a multi-centre parallel-group randomised control trial (ISRCTN64480977), carried out in three European cities (Lahti, Limerick, Tallinn). The sample comprised 101 adults, self-reported as inactive at baseline (IPAQ), aged between 25-65 years. Participants were instructed to engage in outdoor PA (walking/running) at least three times/week, at least 30 minutes/session, over eight weeks. They were randomly allocated into two groups, based on the type of outdoor spaces where they would perform their activities: “nature-based” and “road/sidewalk-based” spaces. PA (light PA, LPA; moderate-to-vigorous PA, MVPA) and SED were measured at baseline and during week-8 of the intervention, over 9-consecutive days, using activPAL accelerometers. Between- and within-group differences were analysed using General Linear Model, adopting a significance level of 95%. Results There were no significant between-groups differences. A significant time-effect was observed for total weekly LPA (ρ = 0.014;η2=0.06) and MVPA (ρ &amp;lt; 0.001;η2=0.126), but not for weekly average SED (ρ = 0.117). Specifically, LPA decreased from 511.1min/week to 489.1min/week in “nature-based” group, and from 539.3min/week to 498.2min/week in “road/sidewalk-based” group. Conversely, MVPA increased from 219.5min/week to 262min/week in “nature-based” group, and from 227.6min/week to 269.6min/week in “road/sidewalk-based” group. No significant group-time effect was observed, indicating that both “nature-based” and “road/sidewalk-based” groups provide changes in PA. Conclusions Outdoor spaces can be relevant venues for promoting PA engagement and increasing MVPA. Further analysis can provide insights into the relationship between environmental quality and PA, but these preliminary findings suggest that both “nature-based” and road/sidewalk-based” spaces have shown to be relevant to getting people active. Urban cities must develop strategic plans aimed at designing urban spaces that are conducive to PA, promoting its practice, that would positively impact population health. Funding EU-2020 (DOI:10.3030/869764).

Impact of mediastinal tumor burden and lymphatic spread in locally advanced non-small-cell lung cancer: A secondary analysis of the multicenter randomized PET-Plan trial

PurposeThe aim of this secondary analysis of the prospective randomized phase 2 PET-Plan trial (ARO-2009-09; NCT00697333) was to evaluate the impact of mediastinal tumor burden and lymphatic spread in patients with locally advanced non-small-cell lung cancer (NSCLC). MethodsAll patients treated per protocol (n = 172) were included. Patients received isotoxically dose-escalated chemoradiotherapy up to a total dose of 60–74 Gy in 30–37 fractions, aiming as high as possible while adhering to normal tissue constraints. Radiation treatment (RT) planning was based on an 18F-FDG PET/CT targeting all lymph node (LN) stations containing CT positive LNs (i.e. short axis diameter > 10 mm), even if PET-negative (arm A) or targeting only LN stations containing PET-positive nodes (arm B). LN stations were classified into echelon 1 (ipsilateral hilum), 2 (ipsilateral station 4 and 7), and 3 (rest of the mediastinum, contralateral hilum). The endpoints were overall survival (OS), progression-free survival (PFS), and freedom from local progression (FFLP). ResultsThe median follow-up time (95 % confidence interval [CI]) was 41.1 (33.8 − 50.4) months. Patients with a high absolute number of PET-positive LN stations had worse OS (hazard ratio [HR] = 1.09; 95 % CI 0.99 − 1.18; p = 0.05) and PFS (HR = 1.12; 95 % CI 1.04 − 1.20; p = 0.003), irrespective of treatment arm allocation. The prescribed RT dose to the LNs did not correlate with any of the endpoints when considering all patients. However, in patients in arm B (i.e., PET-based selective nodal irradiation), prescribed RT dose to each LN station correlated significantly with FFLP (HR=0.45; 95 % CI 0.24–0.85; p = 0.01). Furthermore, patients with involvement of echelon 3 LN stations had worse PFS (HR = 2.22; 95 % CI 1.16–4.28; p = 0.02), also irrespective of allocation. ConclusionMediastinal tumor burden and lymphatic involvement patterns influence outcome in patients treated with definitive chemoradiotherapy for locally advanced NSCLC. Higher dose to LNs did not improve OS, but did improve FFLP in patients treated with PET-based dose-escalated RT.

WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts—study protocol for a multicentre randomised non-inferiority trial

BackgroundEndoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts.MethodsThe WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator’s discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs.DiscussionThe WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population.Trial registrationClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.

Wound healing after intracutaneous vs. staple-assisted skin closure in lumbar, non-instrumented spine surgery: a multicenter prospective randomized trial.

Superficial surgical site infection (SSSI) is a prominent problem in spine surgery. Intracutaneous sutures and staple-assisted closure are two widely used surgical techniques for skin closure. Yet, their comparative impact on wound healing and infection rates is underexplored. Our goal was to address this gap and compare wound healing between these two techniques. This study was a multicenter international prospective randomized trial. Patient data were prospectively collected at three large academic centers, patients who underwent non-instrumented lumbar primary spine surgery were included. Patients were intraoperatively randomized to either intracutaneous suture or staple-assisted closure cohorts. The primary endpoint was SSSI within 30days after surgery according to the wound infection Centers for Disease Control and Prevention (CDC) classification system. Of 207 patients, 110 were randomized to intracutaneous sutures and 97 to staple-assisted closure. Both groups were homogenous with respect to epidemiological as well as surgical parameters. Two patients (one of each group) suffered from an A1 wound infection at the 30-day follow up. Median skin closure time was faster in the staple-assisted closure group (198s vs. 13s, p < 0,001). This study showed an overall low superficial surgical site infection rate in both patient cohorts in primary non instrumented spine surgery.