Prospective Multicenter Study Research Articles

Effect of cardiopulmonary resuscitation training for layperson bystanders on outcomes of out-of-hospital cardiac arrest: A prospective multicenter observational study

BackgroundEffective bystander cardiopulmonary resuscitation (CPR) improves outcomes in out-of-hospital cardiac arrest (OHCA) patients. However, the effect of CPR training on the rate of return of spontaneous circulation (ROSC) among laypersons has yet to be thoroughly evaluated. MethodsThis prospective, multicenter observational study was conducted across 42 centers in Japan. We assessed OHCA patients who received bystander CPR from a layperson, excluding those performed by healthcare staff. The primary outcome was the ROSC rate. Secondary outcomes included pre-hospital ROSC, ROSC after hospital arrival, favorable neurological outcomes, and 30-day survival. Propensity score with inverse probability treatment weighting (IPTW) was used to adjust for confounders, including age, sex, presence or absence of witnesses, and past medical history. ResultsA total of 969 OHCA patients were included, divided into CPR-trained (n = 322) and control (n = 647). Before adjustment, the ROSC rate was higher in the trained group than the control (40.1% vs. 30.1%, P < 0.01). After IPTW adjustment, the trained group showed a significantly higher ROSC rate (36.7% vs. 30.6%; P = 0.02). All secondary outcomes in the trained group were significantly improved before adjustment. After IPTW adjustment, the trained group showed improved rates of pre-hospital ROSC and ROSC after hospital arrival (30.7% vs. 24.0%; P < 0.01, 23.9% vs. 20.7%; P = 0.04). There were no differences in neurological outcomes and 30-day survival. ConclusionThis study demonstrated that CPR training for laypersons was associated with increased ROSC rates in OHCA patients, indicating potential advantages of CPR training for non-healthcare professionals.

Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort study

The clinical relevance of recurrent venous thromboembolism (VTE) after discontinuing anticoagulation in patients with COVID-19-associated VTE remains uncertain. We estimated the incidence rates and mortality of VTE recurrences developing after discontinuing anticoagulation in patients with COVID-19-associated VTE. A prospective, multicenter, non-interventional study was conducted between March 25, 2020, and July 26, 2023, including patients who had discontinued anticoagulation after at least 3 months of therapy. All patients from the registry were analyzed during the study period to verify inclusion criteria. Patients with superficial vein thrombosis, those who did not receive at least 3 months of anticoagulant therapy, and those who were followed for less than 15 days after discontinuing anticoagulation were excluded. Outcomes were: 1) Incidence rates of symptomatic VTE recurrences, and 2) fatal PE. The rate of VTE recurrences was defined as the number of patients with recurrent VTE divided by the patient-years at risk of recurrent VTE during the period when anticoagulation was discontinued. Among 1106 patients with COVID-19-associated VTE (age 62.3 ± 14.4 years; 62.9% male) followed-up for 12.5 months (p25-75, 6.3-20.1) after discontinuing anticoagulation, there were 38 VTE recurrences (3.5%, 95% confidence interval [CI]: 2.5-4.7%), with a rate of 3.1 per 100 patient-years (95% CI: 2.2-4.2). No patient died of recurrent PE (0%, 95% CI: 0-7.6%). Subgroup analyses showed that patients with diagnosis in 2021-2022 (vs. 2020) (Hazard ratio [HR] 2.86; 95% CI 1.45-5.68) or those with isolated deep vein thrombosis (vs. pulmonary embolism) (HR 2.31; 95% CI 1.19-4.49) had significantly higher rates of VTE recurrences. In patients with COVID-19-associated VTE who discontinued anticoagulation after at least 3 months of treatment, the incidence rate of recurrent VTE and the case-fatality rate was low. Therefore, it conceivable that long-term anticoagulation may not be required for many patients with COVID-19-associated VTE, although further research is needed to confirm these findings. Sanofi and Rovi, Sanofi Spain.

Postoperative risk of bleeding after removal of third molars in healthy patients - a prospective observational clinical study

Removal of third molars in healthy patients is considered a procedure with a low risk of bleeding. However, exactly how low the incidence of postoperative bleeding is remains unclear due to the heterogeneity of available studies. To determine the exact postoperative risk of bleeding after the removal of third molars in healthy patients, a prospective observational multicentre study was conducted. A total of 1,035 patients with complete follow-up was included. Of these, 329 patients reported subsequent bleeding, but did not consult their attending physician. A total of 15 patients visited the hospital, 8 of whom required minimally invasive (re)treatment. No hospitalizations were necessary. There was a large difference between the incidence of postoperative bleeding reported by patients and postoperative bleeding requiring clinical examination and/or treatment. To reduce this difference in future, patients should be given detailed information about what degree of postoperative bleeding is considered normal after removal of a third molar.

Optimal management options for esophageal gastrointestinal stromal tumors (E-GIST)

ObjectiveTo explore the different treatment modalities for esophageal gastrointestinal stromal tumors (E-GIST) and their respective applicability and clinical outcomes. MethodsThis is a retrospective study in which consecutive patients diagnosed with E-GIST at our hospital from January 2017 to August 2023 were included. The clinical characteristics of all the patients as well as long-term quality of life were recorded and analyzed. ResultsA total of 23 (12 males, 11 females) E-GIST patients with a mean age of 56.7 ± 12.0 years were included in this study. Common symptoms, including upper abdominal pain, acid reflux, and heartburn, accounted for over 60 % of cases. Fifteen patients underwent endoscopic resection, five patients underwent surgical resection, two patients underwent surgical resection after receiving preoperative imatinib therapy, and one patient received conservative management. ConclusionDifferent treatment strategies may be applied to the patients with E-GIST depending on the their clinical features. Our study provides insights into precise treatment for different patients. However, due to the rarity of the disease, it is challenging to collect a large sample size from a single center, necessitating more multicenter prospective large-scale studies.

Cost-effectiveness and safety of continuous pulse oximetry for management of undiagnosed obstructive sleep apnea in bariatric surgery: a nationwide cohort study

BackgroundUndetected obstructive sleep apnea (OSA) is highly prevalent in patients undergoing bariatric surgery and increases perioperative risks. Screening for OSA using preoperative polygraphy (PG) with subsequent continuous positive airway pressure (CPAP) is costly and time-consuming. Postoperative continuous pulse oximetry (CPOX) is less invasive, and is hypothesized to be a safe and cost-effective alternative. ObjectivesThis nationwide multicenter prospective observational cohort study compared CPOX monitoring with OSA-screening using PG. SettingsHigh-volume bariatric centers. MethodsPatients were either postoperatively monitored using CPOX without pre-operative OSA-screening, or underwent pre-operative PG and CPAP treatment when OSA was diagnosed. Cohort placement was based on local hospital protocols. Cost-effectiveness was analyzed using quality adjusted life years (QALY) and healthcare costs. Surgical outcomes were also analyzed. Propensity score matching was used in sensitivity analyses. ResultsA total of 1390 patients was included. QALYs were similar between groups at baseline and one-year postoperatively. Postoperative complications, ICU-admissions and admissions, particularly OSA-related, did not differ between groups. Mean costs per patient/year in the CPOX group was €3,094 vs. €3,680 in the PG group; mean difference €-586 (95% CI €-933 to €-242). Following propensity score matching, 1090 of 1390 included patients remained, and similar findings for cost-effectiveness, complications and ICU admissions were observed. ConclusionCPOX monitoring without pre-operative OSA-screening was not associated with higher complication or readmission rates compared to PG. CPOX resulted in lower costs from a healthcare perspective and can therefore be considered a cost-effective alternative to routine OSA-screening in patients undergoing bariatric surgery.

Monitoring levetiracetam concentration in saliva during pregnancy is stable and feasible.

This multicenter prospective cohort study (registration no. ChiCTR2000032089) aimed to investigate the relationship between saliva and plasma levetiracetam concentrations to determine whether saliva could be used for routine monitoring of levetiracetam during pregnancy. The slot concentrations of levetiracetam in simultaneously obtained saliva and plasma samples were measured using UPLC-MS/MS. The correlations between saliva and plasma levetiracetam concentrations and the dose-normalized concentrations were compared among pregnant women in different stages and nonpregnant control participants with epilepsy. In total, 231 patients with 407 plasma and saliva sample pairs were enrolled from 39 centers. Linear relationships between salivary and plasma levetiracetam concentrations were reported in the enrolled population (r = 0.898, p < 0.001), including pregnant (r = 0.935, p < 0.001) and nonpregnant participants (r = 0.882, p < 0.001). Plasma concentrations were moderately higher than saliva concentrations, with ratios of saliva to plasma concentrations of 0.98 for nonpregnant women, 0.98, 1, and 1.12 for pregnant women during the first trimester, the second trimester, the and third trimester, respectively. The effective range of saliva levetiracetam concentration was found to be 9.98 μg/mL (lower limit) with an area under the curve (AUC) of 0.937 (95% confidence intervals, 0.915-0.959), sensitivity of 88.9%, specificity of 86.8%, and p < 0.001, to 24.05 μg/mL (upper limit) with an AUC of 0.952 (0.914-0.99), sensitivity of 100%, specificity of 92.3%, and p = 0.007. The saliva/plasma concentration ratio of levetiracetam remains constant during pregnancy and is similar to that in non-pregnant individuals. Monitoring levetiracetam concentration in saliva during pregnancy should be widely promoted.

Psychosocial outcomes following emergency laparotomy (POLO) study: a study protocol for a multicentre mixed-methods prospective cohort study assessing the psycho-social outcomes following emergency laparotomy in adults

IntroductionMorbidity from an emergency laparotomy (EmLap) is difficult to define and poorly understood. Morbidity is a holistic concept, reliant upon an interplay of bio-psychosocial outcomes that evolve long after discharge....

PECARN prediction rule for cervical spine imaging of children presenting to the emergency department with blunt trauma: a multicentre prospective observational study.

Cervical spine injuries in children are uncommon but potentially devastating; however, indiscriminate neck imaging after trauma unnecessarily exposes children to ionising radiation. The aim of this study was to derive and validate a paediatric clinical prediction rule that can be incorporated into an algorithm to guide radiographic screening for cervical spine injury among children in the emergency department. In this prospective observational cohort study, we screened children aged 0-17 years presenting with known or suspected blunt trauma at 18 specialised children's emergency departments in hospitals in the USA affiliated with the Pediatric Emergency Care Applied Research Network (PECARN). Injured children were eligible for enrolment into derivation or validation cohorts by fulfilling one of the following criteria: transported from the scene of injury to the emergency department by emergency medical services; evaluated by a trauma team; and undergone neck imaging for concern for cervical spine injury either at or before arriving at the PECARN-affiliated emergency department. Children presenting with solely penetrating trauma were excluded. Before viewing an enrolled child's neck imaging results, the attending emergency department clinician completed a clinical examination and prospectively documented cervical spine injury risk factors in an electronic questionnaire. Cervical spine injuries were determined by imaging reports and telephone follow-up with guardians within 21-28 days of the emergency room encounter, and cervical spine injury was confirmed by a paediatric neurosurgeon. Factors associated with a high risk of cervical spine injury (>10%) were identified by bivariable Poisson regression with robust error estimates, and factors associated with non-negligible risk were identified by classification and regression tree (CART) analysis. Variables were combined in the cervical spine injury prediction rule. The primary outcome of interest was cervical spine injury within 28 days of initial trauma warranting inpatient observation or surgical intervention. Rule performance measures were calculated for both derivation and validation cohorts. A clinical care algorithm for determining which risk factors warrant radiographic screening for cervical spine injury after blunt trauma was applied to the study population to estimate the potential effect on reducing CT and x-ray use in the paediatric emergency department. This study is registered with ClinicalTrials.gov, NCT05049330. Nine emergency departments participated in the derivation cohort, and nine participated in the validation cohort. In total, 22 430 children presenting with known or suspected blunt trauma were enrolled (11 857 children in the derivation cohort; 10 573 in the validation cohort). 433 (1·9%) of the total population had confirmed cervical spine injuries. The following factors were associated with a high risk of cervical spine injury: altered mental status (Glasgow Coma Scale [GCS] score of 3-8 or unresponsive on the Alert, Verbal, Pain, Unresponsive scale [AVPU] of consciousness); abnormal airway, breathing, or circulation findings; and focal neurological deficits including paresthesia, numbness, or weakness. Of 928 in the derivation cohort presenting with at least one of these risk factors, 118 (12·7%) had cervical spine injury (risk ratio 8·9 [95% CI 7·1-11·2]). The following factors were associated with non-negligible risk of cervical spine injury by CART analysis: neck pain; altered mental status (GCS score of 9-14; verbal or pain on the AVPU; or other signs of altered mental status); substantial head injury; substantial torso injury; and midline neck tenderness. The high-risk and CART-derived factors combined and applied to the validation cohort performed with 94·3% (95% CI 90·7-97·9) sensitivity, 60·4% (59·4-61·3) specificity, and 99·9% (99·8-100·0) negative predictive value. Had the algorithm been applied to all participants to guide the use of imaging, we estimated the number of children having CT might have decreased from 3856 (17·2%) to 1549 (6·9%) of 22 430 children without increasing the number of children getting plain x-rays. Incorporated into a clinical algorithm, the cervical spine injury prediction rule showed strong potential for aiding clinicians in determining which children arriving in the emergency department after blunt trauma should undergo radiographic neck imaging for potential cervical spine injury. Implementation of the clinical algorithm could decrease use of unnecessary radiographic testing in the emergency department and eliminate high-risk radiation exposure. Future work should validate the prediction rule and care algorithm in more general settings such as community emergency departments. The Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Health Resources and Services Administration of the US Department of Health and Human Services in the Maternal and Child Health Bureau under the Emergency Medical Services for Children programme.

Shortened progression free and overall survival to immune-checkpoint inhibitors in BRAF-, RAS- and NF1- (“Triple”) wild type melanomas

BackgroundMelanomas lacking mutations in BRAF, NRAS and NF1 are frequently referred to as “triple wild-type” (tWT) melanomas. They constitute 5-10% of all melanomas and remain poorly characterized regarding clinical characteristics and response to therapy. This study investigates the largest multicenter collection of tWT-melanomas to date. MethodsTargeted next-generation sequencing of the TERT promoter and 29 melanoma-associated genes were performed on 3109 melanoma tissue samples of the prospective multicenter study ADOREG/TRIM of the DeCOG. revealing 292 patients suffering from tWT-melanomas. Clinical characteristics and mutational patterns were analyzed. As subgroup analysis, we analyzed 141 tWT-melanoma patients receiving either anti-CTLA4 plus anti-PD1 or anti PD1 monotherapy as first line therapy in AJCC stage IV. Results184 patients with cutaneous melanomas, 56 patients with mucosal melanomas, 34 patients with acral melanomas and 18 patients with melanomas of unknown origin (MUP) were included. A TERT promoter mutation could be identified in 33.2% of all melanomas and 70.5% of all tWT-melanomas harbored less than three mutations per sample. For the 141 patients with stage IV disease, mPFS independent of melanoma type was 6.2 months (95% CI: 4-9) and mOS was 24.8 months (95% CI: 14.2-53.4) after first line anti-CTLA4 plus anti-PD1 therapy. After first-line anti-PD1 monotherapy, mPFS was 4 months (95%CI: 2.9-8.5) and mOS was 29.18 months (95% CI: 17.5-46.2). ConclusionsWhile known prognostic factors such as TERT promoter mutations and TMB were equally distributed among patients who received either anti-CTLA4 plus anti-PD1 combination therapy or anti-PD1 monotherapy as first line therapy, we did not find a prolonged mPFS or mOS in either of those. For both therapy concepts, mPFS and mOS were considerably shorter than reported for melanomas with known oncogene mutations.

Prognostic Factors and Clinical Outcomes in Patients with Blast Phase Chronic Myeloid Leukemia.

Given the low incidence of patients with advanced chronic myeloid leukemia (CML), comprehensive clinical characteristics and outcomes of cohort studies of patients diagnosed with blast phase chronic myeloid leukemia (BP-CML) are limited. We examined the clinical features of blast phase CML, including the TKI selection, treatment response, and whether they have had hematopoietic stem cell transplantation (HSCT) or not. We performed a retrospective cohort study, including BP-CML patients diagnosed in our center from January 2013 to December 2022. Clinical features, treatment therapy, and overall survival (OS) were investigated. Out of the 11 patients, 2 were myeloid type, eight patients were B-lymphoid, and one was T-lymphoid. Four patients suffered from chromosome abnormalities. Four patients were identified with BCR-ABL1 kinase domain mutation, including T315I, E255K, M244v, and E279K. The overall CR, CRi, PR, and MLFS rates were 9%, 54%, 27%, and 9%, respectively. The median follow-up was 21 months (9.5 - 33 months). At the end of the follow-up time, seven patients died. CML patients with lymphoids tended to get a better OS than patients with a type of myeloid, but the difference was not statistically significant (p > 0.05). Patients who received HSCT had an improved OS by two years compared to those who had not received HSCT. The prognosis of BP-CML patients was poor. Given the rarity of BP-CML and the limitation of clinical trial data, large-scale multi-center prospective studies are urgently needed to confirm and improve the treatment of patients with BP-CML in the future.

Phenotypic subgroup in serologically active clinically quiescent systemic lupus erythematosus: A cluster analysis based on CSTAR cohort.

Serologically active clinically quiescent (SACQ) is a state within systemic lupus erythematosus (SLE) characterized by elevated serologic markers without clinical activity. The heterogeneity in SACQ patients poses challenges in disease management. This multicenter prospective study aimed to identify distinct SACQ subgroups and assess their utility in predicting organ damage. SACQ was defined as a sustained period of at least 6months with persistent serologic activity, marked by positive anti-double-stranded DNA (dsDNA) antibodies and/or hypocomplementemia, and without clinical activity. Cluster analysis was employed, utilizing 16 independent components to delineate phenotypes. Among the 4,107 patients with SLE, 990 (24.1%) achieved SACQ within 2.0± 2.3 years on average. Over a total follow-up of 7,105.1 patient years, 340 (34.3%) experienced flares, and 134 (13.5%) developed organ damage. Three distinct SACQ subgroups were identified. Cluster 1 (n= 219, 22.1%) consisted predominantly of elderly males with a history of major organ involvement at SLE diagnosis, showing the highest risk of severe flares (16.4%) and organ damage (27.9%). Cluster 2 (n= 279, 28.2%) was characterized by milder disease and a lower risk of damage accrual (5.7%). Notably, 86 patients (30.8%) in cluster 2 successfully discontinued low-dose glucocorticoids, with 49 of them doing so without experiencing flares. Cluster 3 (n= 492, 49.7%) featured the highest proportion of lupus nephritis and a moderate risk of organ damage (11.8%), with male patients showing significantly higher risk of damage (hazard ratio [HR]= 4.51, 95% confidence interval [CI], 1.82-11.79). This study identified three distinct SACQ clusters, each with specific prognostic implications. This classification could enhance personalized management for SACQ patients. This work was funded by the National Key R&D Program (2021YFC2501300), the Beijing Municipal Science& Technology Commission (Z201100005520023), the CAMS Innovation Fund (2021-I2M-1-005), and National High-Level Hospital Clinical Research Funding (2022-PUMCH-D-009).

Prognostic Factors and Clinical Outcomes in Patients with Blast Phase Chronic Myeloid Leukemia.

Given the low incidence of patients with advanced chronic myeloid leukemia (CML), comprehensive clinical characteristics and outcomes of cohort studies of patients diagnosed with blast phase chronic myeloid leukemia (BP-CML) are limited. We examined the clinical features of blast phase CML, including the TKI selection, treatment response, and whether they have had hematopoietic stem cell transplantation (HSCT) or not. We performed a retrospective cohort study, including BP-CML patients diagnosed in our center from January 2013 to December 2022. Clinical features, treatment therapy, and overall survival (OS) were investigated. Out of the 11 patients, 2 were myeloid type, eight patients were B-lymphoid, and one was T-lymphoid. Four patients suffered from chromosome abnormalities. Four patients were identified with BCR-ABL1 kinase domain mutation, including T315I, E255K, M244v, and E279K. The overall CR, CRi, PR, and MLFS rates were 9%, 54%, 27%, and 9%, respectively. The median follow-up was 21 months (9.5 - 33 months). At the end of the follow-up time, seven patients died. CML patients with lymphoids tended to get a better OS than patients with a type of myeloid, but the difference was not statistically significant (p > 0.05). Patients who received HSCT had an improved OS by two years compared to those who had not received HSCT. The prognosis of BP-CML patients was poor. Given the rarity of BP-CML and the limitation of clinical trial data, large-scale multi-center prospective studies are urgently needed to confirm and improve the treatment of patients with BP-CML in the future.

The Cardiac Pulsed Wave Doppler Pattern of the Common Femoral Vein in Diagnosing the Likelihood of Severe Pulmonary Hypertension: Results from a Prospective Multicentric Study.

Background and Objectives: Pulmonary hypertension (PH) is a clinical condition with high mortality rates, particularly in patients over 65. Current guidelines recommend assessing the likelihood of pulmonary hypertension (LPH) using advanced echocardiography before proceeding to right heart catheterization. This study proposed using the common femoral vein (CFV), an accessible vein that reflects right atrial pressure, as an alternative method to assess the high likelihood of pulmonary hypertension (H-LPH). Materials and Methods: This prospective observational study included 175 emergency patients from three hospitals. Ultrasound assessed the pulsed wave Doppler (PW-Doppler) morphology of the CFV. This diagnostic yield for H-LPH was evaluated alongside traditional ultrasound parameters (right-to-left ventricular basal diameter ratio greater than 1 (RV > LV), septal flattening, right ventricular outflow acceleration time (RVOT) of less than 105 ms and/or mesosystolic notching, pulmonary artery diameter greater than the aortic root (AR) diameter or over 25 mm, early pulmonary regurgitation maximum velocity > 2.2 m/s; TAPSE/PASP less than 0.55, inferior vena cava (IVC) diameter over 21 mm with decreased inspiratory collapse, and right atrial (RA) area over 18 cm2). Results: The CFV's PW-Doppler cardiac pattern correlated strongly with H-LPH, showing a sensitivity (Sn) of 72% and a specificity (Sp) of 96%. RA dilation and TAPSE/PASP < 0.55 also played significant diagnostic roles. Conclusions: The CFV's PW-Doppler cardiac pattern is an effective indicator of H-LPH, allowing reliable exclusion of this condition when absent. This approach could simplify initial LPH evaluation in emergency settings or where echocardiographic resources are limited.

Postoperative complications and hernia recurrence after the use of various ventral hernia repair techniques

Prosthetic hernioplasty (HP) for ventral hernias (VH) has a complication rate of up to 27% and a hernia recurrence rate up of to 37%, depending on the chosen technique. The use of laparoscopic HP techniques allows for a shorter hospital stay and a lower risk of wound infection. There is a wide range of data on the superiority of laparoscopy over the open technique in terms of recurrence rates and various types of complications. The results of comparing HP with and without suturing of the hernia defect are controversial. Objective — to study the structure and incidence of postoperative complications, as well as the frequency of hernia recurrences after the use of open and laparoscopic HP for VH. Materials and methods. A multicenter prospective study, which included 482 patients diagnosed with VH, was conducted at the clinical base of the Department of General Surgery No. 2 at Bogomolets National Medical University. A total of 279 (57.9%) patients had primary VH, while 203 (42.1%) had incisional VH. The patients were divided into two groups, comparable in terms of age, sex, and hernia size distribution. Group 1 included 250 (51.9%) patients who underwent open HP with suturing of the hernia defect: subgroup 1a — open sublay (n=243; 50.4%), and subgroup 1b — open intraperitoneal onlay mesh technique (IPOM) (n=7; 1.5%). Group 2 included 232 (48.1%) patients who underwent laparoscopic HP using the IPOM technique: subgroup 2a — IPOM without suturing of the aponeurosis defect (n=81; 16.8%), subgroup 2b — IPOM with suturing of the aponeurosis defect (n=108; 22.4%), and subgroup 2c — IPOM+ with open aponeurosis defect suturing (n=43; 8.9%). Follow‑up evaluations were carried out at intervals of 2 weeks, 1 month, 6 months, and 1 year to assess the presence of complications, recurrence, and satisfaction with the cosmetic effect of the operation. Results. The overall frequency of complications after HP was 15.6%, while after open sublay it was 21.2%, and after laparoscopic IPOM it was 9.9%. All cases of complications belonged to Grades I—IIIb according to the Clavien‑Dindo classification. In both groups, there were no fatalities. In group 1, the frequency of seroma was 11.6% and hematoma was 5.6%, and in group 2, it was 7.3% and 0.9%, respectively. A statistically significant increase in the frequency of hematoma development was observed after open HP techniques compared to laparoscopic ones (p=0.004), while the frequency of seroma detection was comparable (p=0.148). Non‑suturing of the aponeurosis defect after laparoscopic IPOM in patients with VH did not result in an increase in the total number of complications or the percentage of recurrence (p &gt;0.05). Laparoscopic IPOM with hernia suturing demonstrated significantly higher patient satisfaction with the appearance of the anterior abdominal wall compared to other HP techniques (р &lt;0.05). Conclusions. The open sublay and laparoscopic IPOM HP procedures have a comparable recurrence rate of VH (p &gt;0.05). The incidence of infectious complications and hematomas is significantly higher after open operations compared to laparoscopic ones (p=0.041 and p=0.004, respectively).

Preliminary results of Polish national multicenter LILEO study on ileostomy reversal

Introduction: Ileostomy reversal is a common surgical procedure and currently standardized perioperative and surgical protocols are lacking. Aim: LILEO study was designed to perform a multicenter analysis on numerous perioperative parameters and estimation of the incidence of postoperative complications.Materials and methods: The study is an open multicenter prospective cohort study. Preliminary results of the LILEO study after 3 months were available from 18 Polish surgical centers comprising full data of 59 patients who underwent ileostomy reversal.Results: Parameters such as preoperative care, surgical technique, postoperative course and complications were analyzed. Preoperative fasting was used in 49,1% of patients. Fifty nine percent of anastomosis were handsewn and in 72,9% of patients had primary single suture wound closure. Mean length of hospital stay was 7,9 days (min 2 days, max 26 days). Complications occurred overall in 20 patients (33,9%). In 11,9% of patient’s complications had grade 3 A/B in Clavien-Dindo classification. Discussion: The perioperative care in the group of patients undergoing ileostomy reversal still lacks standardized and optimized treatment.Conclusions: Ileostomy removal is a procedure with high risk of postoperative complications. Standardization of perioperative care based on further multicenter national study could result in a decrease of complications rate.

Feasibility of articulating laparoscopic instrument use in laparoscopic adnexectomy: a multicenter prospective observational study.

Ovarian cysts, common in women of reproductive age, often require surgical intervention, with minimally invasive laparoscopic surgery becoming the preferred method due to its reduced complications and faster recovery. Despite its benefits, challenges such as instrument collisions and operational difficulties limit the use of single- or two-port approaches. The purpose of this study was to evaluate the feasibility of laparoscopic adnexa surgery using an articulating laparoscopic instrument, which offers flexible and ergonomic movements similar to robotic systems. This multicenter prospective observational study was conducted in South Korea and Taiwan. The electronic medical records of patients who underwent laparoscopic adnexectomy using the articulating laparoscopic instrument (ArtiSential®, LIVSMED Inc., Seongnam-si, South Korea) between October 2022 and September 2023 were analyzed. Data on patient demographics, operative and pathologic data were collected prospectively. A total of 66 patients underwent laparoscopic adnexal surgery using the articulating instrument. The median age of the patients was 43 (range, 23-76) years, and the median body mass index (BMI) was 22.5 (range, 17.1-43.4) kg/m2. Thirty-five (53.0%) patients underwent oophorectomy or salpingectomy, while 31 (47.0%) underwent cystectomy of the ovary or fallopian tube. The final pathology after surgery was benign in 61 patients (92.4%), borderline in 3 patients (4.5%), and malignant in 2 patients (3.0%). During surgery, pelvic adhesions were found in 13 patients (19.7%) and adhesiolysis was performed. The median total operation time was 53.5 (range, 26-174) minutes, and median estimated blood loss (EBL) was 50 (range, 10-200) mL. Median length of hospital stay was 1 (range, 0-3) days. Only two patients experienced a postoperative complication, which was trocar site wound dehiscence in both cases. The results of this study demonstrated the feasibility of using the articulating laparoscopic instrument during laparoscopic adnexectomy.

Seroprevalence of transfusion-transmitted infections among blood donors in Makkah, Saudi Arabia.

Blood donation is vital for healthcare; however, transfusion-transmitted infections (TTIs) pose a serious risk. This study investigated the seroprevalence of TTIs among Saudi blood donors. This retrospective study included male blood donors aged ≥ 18 years who donated blood at Al-Noor Specialist Hospital in Makkah from January 2017 to December 2022. The blood units were screened for hepatitis B surface antigen (HBsAg) and core antibodies (HBc-IgG), hepatitis C antibodies (HCV-Abs), syphilis, HIV-1 antigen/antibody (HIV-1 Ag/Ab), human T-lymphotropic virus 1, 2 (HTLV-1/2), and malaria. There were 40,287 donors with an average age of 44.33 ± 18.12 years, and 62.3% (n = 25103) were Saudis. The overall rate of TTIs seropositivity was 7.4% (n = 2953); HBc-IgG (6.1%; n = 2473) was the most common, followed by HCV-Abs (0.4%; n = 177), and syphilis (0.34%; n = 136). All cases were negative for malaria, whilst HIV and HTLV positive donors were 0.06% (n = 24) and 0.13% (n = 52), respectively. Syphilis was more prevalent among non-Saudis (0.24%; n = 83) than among Saudis (0.1%; n = 53), whereas anti-HBc antibodies seropositivity was significantly higher among Saudi (3.4%; n = 1373) than non-Saudi donors (2.7%; n = 1100). Hepatitis B virus was the most frequently detected bloodborne pathogen, followed by hepatitis C virus and syphilis. Hepatitis B virus was also more prevalent among Saudi donors, whilst expatriates had higher rates of syphilis. Additional prospective multicenter studies are needed to accurately determine the prevalence of TTIs in Saudi Arabia.

Time-to-Treatment Delays and Their Prognostic Implications in Pharyngeal Cancer—An Exploratory Analysis in Western Romania

Background: Diagnosis and treatment for pharyngeal cancer are decisive in determining prognosis. Diagnosis delays are frequent, representing a significant cause of avoidable mortality, and an important factor in subpar survival across the continuous HNC care delivery. Methods: The present study represents a retrospective analysis of medical records from Western Romania, which included 180 patients, to evaluate the impact of time-to-treatment delay on patients diagnosed with pharyngeal cancer. The data analyses were performed using the Kaplan–Meier method R (version 3.6.3) packages, including tidyverse, final-fit, mcgv, survival, stringdist, janitor, and Hmisc. Results: The mean days from diagnosis until the end of treatment were higher for the nasopharynx group. Cox regression analysis regarding diagnosis to treatment duration categories showed an increased risk mortality by 3.11 times (95%CI: 1.51–6.41, p = 0.0021) with a Harrell’s C-index of 0.638 (95%CI: 0.552–0.723). The hypopharynx and oropharynx locations increased risk mortality by 4.59 (95%CI: 1.55–13.55) and 5.49 times (95%CI: 1.79–16.81) compared to the nasopharynx location. Conclusions: The findings of this study led to the conclusion that it seems there is a trend of mortality risk for oropharynx and hypopharynx cancers due to delays in the time to treatment over 70 days, standing as a basis for further research as there is an imperative need for prospective multicenter studies.

Frailty Index Based on Common Laboratory Tests for Patients Starting Home-Based Medical Care

ObjectivesTo determine whether a Frailty Index based on laboratory tests (FI-lab) is associated with clinical outcomes independently of a standard nonlaboratory Frailty Index (FI-clinical) in older patients starting home-based medical care. DesignSecondary analysis of data from a multicenter prospective cohort study. Setting and ParticipantsPatients aged ≥65 years who were starting home-based medical care services provided by doctors and nurses at Nagoya, Japan. MethodsWe calculated FI-lab (proportion of abnormal results out of 25 commonly tested laboratory parameters) and FI-clinical using 42 items based on data obtained at enrollment. The primary outcome was mortality within 2 years after starting home-based medical care. A sensitivity analysis was also conducted with 1-year mortality as the outcome. Other outcomes included hospitalization and nursing home admission within 2 years. ResultsIn total, 188 patients (mean age 79.9 ± 10.2 years, 57.5% male) were included. The median FI-lab was 0.40 [interquartile range (IQR) 0.29-0.50] and the median FI-clinical was 0.32 (IQR 0.24-0.43). Sixty-nine patients (36.7%) died within 2 years of starting home-based medical care. A Cox proportional hazards regression analysis including age, sex, FI-lab, and FI-clinical as independent variables revealed that FI-lab was associated with 2-year mortality independently of FI-clinical [FI-lab per 0.1 unit, odds ratio (OR) 1.49, 95% CI 1.25-1.77; FI-clinical per 0.1 unit, OR 1.13, 95% CI 0.90-1.41]. The sensitivity analysis showed similar results for 1-year mortality. Neither FI-lab nor FI-clinical was associated with hospitalization or nursing home admission within 2 years. Conclusions and ImplicationsFI-lab was associated with 2-year mortality in patients starting home-based medical care, independently of FI-clinical, and may be useful for risk assessment in this population. Studies with larger sample sizes are needed.

Anti-VEGF Pharmaceutical Prior Authorization in Retina Practices

Anti-vascular endothelial growth factor (VEGF) intravitreal injections, a mainstay of treatment for many retinal diseases to optimize visual outcomes, have been included in prior authorization (PA) initiatives. However, if clinicians are extremely accurate in their use of anti-VEGF medications, such administrative burdens may need reconsideration. To quantify PA for anti-VEGF medications (aflibercept, ranibizumab, and bevacizumab) that were approved and determine associated administrative burdens experienced by retina practices. Prospective multicenter quality improvement study conducted from January 2022 through June 2022, and participants were 9 private retina practices across the US. Overall rate of approval of PA requests, reasons for requesting PA, and overall rate of delay of care resulting from PA procedures. In total, 2365 PA requests were recorded, 2225 of which met inclusion criteria. Overall, 2140 (96.2%) requests were approved. The most common reason for requesting PA, at 64% (1423 of 2225 requests), was reauthorization for a previously utilized medication. Of the 2140 approvals, 59.6% (1277) resulted in a delay in care greater than 24 hours, and 40% (863) were given on the date of service. In a granular analysis of a subset of delayed approvals, 23.9% (173 of 725) were approved within 1 day, 15.9% (115 of 725) were approved within 2 to 3 days, 21.5% (156 of 725) were approved within 4 to 7 days, 26.3% (191 of 725) were approved within 8 to 31 days, and 12.4% (90 of 725) were approved within more than 31 days. Overall, PA denial for step therapy was 2.9% (65 of 2225) of requests and uncovered diagnoses was 0.9% (20 of 2225) of requests. The median staff time spent to obtain a single PA was 100 (range, 0-200) minutes. In this study, PA requests were almost always approved but led to a delay in patient care in most patients. The current study suggests that the PA process may not be effective for retina specialists if these results can be generalized to other practices in the US and if less burdensome and less costly approaches could result in similar approval rates. Potential short-term solutions may include eliminating the PA process for bevacizumab and reauthorizations for established patients.