mFOLFIRINOX versus mFOLFOX 6 as adjuvant treatment for high-risk stage III colon cancer - the FROST trial: study protocol for a multicenter, randomized controlled, phase II trial.

BACKGROUND: High-risk stage III colon cancer has a considerably poorer prognosis than stage II and low-risk stage III colon cancers. Nevertheless, most guidelines recommend similar adjuvant treatment approaches for all these stages despite the dearth of research focusing on high-risk stage III colon cancer and the potential for improved prognosis with intensive adjuvant treatment. Given the the proven efficacy of triplet chemotherapy in metastatic colorectal cancer treatment, the goal of this study is to evaluate the oncologic efficacy and safety of mFOLFIRINOX in comparison to those of the current standard of care, mFOLFOX 6, as an adjuvant treatment for patients diagnosed with high-risk stage III colon cancer after radical resection. METHODS: This multicenter, randomized (1:1), open-label, phase II trial will assess and compare the effectiveness and toxicity of mFOLFIRINOX and mFOLFOX 6 in patients with high-risk stage III colon cancer after radical resection. The goal of the trial is to enroll 312 eligible patients, from 11 institutes, aged between 20 and 70 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, or between 70 and 75 with an ECOG performance status of 0. Patients will be randomized into two arms - Arm A, the experimental arm, and Arm B, the reference arm - and will receive 12 cycles of mFOLFIRINOX and mFOLFOX 6 every 2 weeks, respectively. The primary endpoint of this study is the 3-year disease-free survival, and secondary endpoints include the 3-year overall survival and treatment toxicity. DISCUSSION: The Frost trial would help determine the oncologic efficacy and safety of adjuvant triplet chemotherapy for high-risk stage III colon cancers and ultimately improve prognoses. TRIAL REGISTRATION: ClinicalTrials.gov NCT05179889, registered on 17 December 2021.

Bridging Molecular Mechanism and Clinical Practice in Vitiligo Treatment: An Updated Review.

BACKGROUND: Treatment of vitiligo seeks to achieve three goals: cessation of disease progression, regeneration of pigmentation, and prevention of recurrence. SUMMARY: Number of nonsurgical interventions are available that suppress the autoimmune response and regenerate the melanocytes from the reservoir: phototherapy including psoralen and ultraviolet A, narrowband ultraviolet B, and 308-nm excimer and 311-nm Titanium:Sapphire lasers; topical agents including topical calcineurin inhibitors, topical corticosteroids, and topical 5-fluorouracil; and systemic agents including corticosteorids, mycophenolate mofetil, cyclosporine, methotrexate, minocycline, afamelanotide, and antioxidants. In recent years, a great advance has been made in the understanding of pathogenesis of vitiligo, and JAK inhibitors are being investigated as a new treatment. Minimally invasive procedures such as fractional lasers or microneedling can help achieve the optimal treatment outcome when used properly. KEY MESSAGES: Our review describes various treatment modalities for vitiligo based on their molecular mechanism of action. Bridging the gap between molecular mechanisms and therapeutic options would be a valuable reference for physicians in clinical practice.

Consideration of the diameter of superficial temporal arteries related to filler injections in the temporal region.

BACKGROUND: The concavity of the temple due to adipose tissue atrophy from aging accentuates the zygomatic arch and lateral orbital rim, leading to an aged appearance. The use of hyaluronic acid filler in the temporal region has gained popularity due to its procedural simplicity and consistent outcomes. OBJECTIVE: To evaluate the safety of administering hyaluronic acid filler in the temporal region concerning the frontal branch of the superficial temporal artery, which is at risk of injury. METHODS: Empirical observations were conducted on the internal diameter of the frontal branch of the superficial temporal artery, a critical anatomical site for potential injury. RESULTS: A significant proportion of the artery segments exhibited an internal diameter below 1 mm. Given that the outer diameter of an 18-gauge cannula is 1.27 mm, this method can be considered a relatively secure approach for enhancing the temporal region. CONCLUSION: The use of an 18-gauge cannula for hyaluronic acid filler administration in the temporal region appears to be a safe and effective method, with the potential risk to the frontal branch of the superficial temporal artery being minimal.

Factors influencing the quality of life in children with atopic dermatitis in Korea: A multicenter cross-sectional study.

Background: There is a lack of studies about which factors affect the quality of life (QoL) in children with atopic dermatitis (AD), although it is well known that AD has considerably negative effects on their QoL. Objective: This study aimed to measure the QoL in children with AD and identify the factors that affect their QoL. Methods: A questionnaire derived from the Children's Dermatology Life Quality Index (CDLQI) was used to measure QoL. Family history, allergic comorbidities, exacerbation-related factors, time of exacerbation, and previous and current treatment were also evaluated. The total immunoglobulin E (IgE) level and specific IgE sensitization were determined by the multiple allergen simultaneous test, allergy test, or skin-prick test. AD severity was categorized into mild, moderate, and severe based on treatments. Results: In total, 254 children (46.4 months, 53% boys) from seven hospitals completed the survey. The mean CDLQI score was 7.2 ± 5.5 (total score range of 0-30). The respondents were divided into three groups according to their QoL score distribution, with 0 - 4 points (n = 84), 5 - 9 points (n = 90), and ≥10 points (n = 80) representing good, fair, and poor QoL, respectively. The more severe AD showed the higher CDLQI score significantly (p = 0.001). Compared with other groups, children with poor QoL were more sensitized to inhalant allergens (odds ratio [OR] 1.29 [95% confidence interval {CI}], 1.03 - 1.62) and had more exacerbating factors (OR 1.26 [95% CI, 1.04 - 1.54]), which included inhalation allergen-related exacerbating factors (OR 2.54 [95% CI, 1.23 - 5.23), even after adjusting for age, total IgE, body mass index, severity, and use of moisturizer. The concordance between animal sensitization and an exacerbating factor, including dog and cat, was fair, with 0.39 κ and 0.85 accuracy. Conclusion: This study showed that impaired QoL in children with AD is associated with inhalant allergen sensitization and inhalant allergen-related exacerbation factors. Especially, dog and cat sensitization was a significant exacerbating factor. The inhalation-related exacerbation factors, including animal allergens, might be addressed to improve AD management in children.

Hyperactivation of YAP/TAZ Drives Alterations in Mesangial Cells through Stabilization of N-Myc in Diabetic Nephropathy.

SIGNIFICANCE STATEMENT: Mesangial cells (MCs) in the kidney are essential to maintaining glomerular integrity, and their impairment leads to major glomerular diseases including diabetic nephropathy (DN). Although high blood glucose elicits abnormal alterations in MCs, the underlying mechanism is poorly understood. We show that YAP/TAZ are increased in MCs of patients with DN and two animal models of DN. High glucose directly induces activation of YAP/TAZ through the canonical Hippo pathway in cultured MCs. Hyperactivation of YAP/TAZ in mouse MCs recapitulates the hallmarks of DN. Activated YAP/TAZ bind and stabilize N-Myc, one of the Myc family. N-Myc stabilization leads to aberrant enhancement of its transcriptional activity and to MC impairments. Our findings shed light on how high blood glucose in diabetes mellitus leads to DN and support a rationale that lowering blood glucose in diabetes mellitus could delay DN pathogenesis. BACKGROUND: Mesangial cells (MCs) in the kidney are central to maintaining glomerular integrity, and their impairment leads to major glomerular diseases, including diabetic nephropathy (DN). Although high blood glucose elicits abnormal alterations in MCs, the underlying molecular mechanism is poorly understood. METHODS: Immunolocalization of YAP/TAZ and pathological features of PDGFRß + MCs were analyzed in the glomeruli of patients with DN, in Zucker diabetic fatty rats, and in Lats1/2i ΔPß mice. RiboTag bulk-RNA sequencing and transcriptomic analysis of gene expression profiles of the isolated MCs from control and Lats1/2iΔPß mice were performed. Immunoprecipitation analysis and protein stability of N-Myc were performed by the standard protocols. RESULTS: YAP and TAZ, the final effectors of the Hippo pathway, are highly increased in MCs of patients with DN and in Zucker diabetic fatty rats. Moreover, high glucose directly induces activation of YAP/TAZ through the canonical Hippo pathway in cultured MCs. Hyperactivation of YAP/TAZ in mouse model MCs recapitulates the hallmarks of DN, including excessive proliferation of MCs and extracellular matrix deposition, endothelial cell impairment, glomerular sclerosis, albuminuria, and reduced glomerular filtration rate. Mechanistically, activated YAP/TAZ bind and stabilize N-Myc protein, one of the Myc family of oncogenes. N-Myc stabilization leads to aberrant enhancement of its transcriptional activity and eventually to MC impairments and DN pathogenesis. CONCLUSIONS: Our findings shed light on how high blood glucose in diabetes mellitus leads to DN and support a rationale that lowering blood glucose in diabetes mellitus could delay DN pathogenesis.

Assessing residual fragrances on skin after body washing: Optimization of an analytical method using solid-phase microextraction coupled with gas chromatography-mass spectrometry.

OBJECTIVE: The aim of this study is to develop and optimize a method for evaluating the persistence of residual fragrance after body washing, addressing a significant requirement in the development of personal care products. The main objective is to establish a reliable, sensitive and reproducible analytical technique to assess fragrance longevity on skin post-use of body wash products. METHODS: Headspace solid-phase microextraction (HS-SPME) coupled with gas chromatography-mass spectrometry (GC-MS) is used to analyse residual fragrances. We investigate the extraction efficiencies of various SPME fibres and compare different methods for sampling skin-emitted fragrances, including tape stripping and sealed glass funnels. A controlled body-washing procedure is implemented to standardize the cleansing process. RESULTS: Our findings indicate that the relative standard deviation for measuring five distinct fragrances is within the range of 3%-14%, highlighting the precision of the method. A notable variance exists in the extraction efficiency of fragrances using different types of SPME fibres, with some exhibiting over a threefold difference. Furthermore, the glass funnel method for fragrance collection demonstrates an 11.7 times greater sensitivity to galaxolide than that of the tape-stripping method. Residual fragrances with base notes as the main components can be detected on the skin up to 24 h after body washing. CONCLUSION: The optimized method for residual fragrance evaluation developed in this study offers a robust tool for analysing fragrance components persisting on the skin for up to 24 h post-wash. This advancement facilitates a deeper understanding of fragrance longevity in personal care products, enabling comparative analyses between different products.

OBJECTIF: l'objectif de cette étude est de développer et d'optimiser une méthode d'évaluation de la persistance du parfum résiduel après la toilette du corps, répondant à une exigence significative dans le développement de produits de soins personnels. L'objectif principal est d'établir une technique analytique fiable, sensible et reproductible pour évaluer la longévité des parfums sur la peau après utilisation de produits de toilette pour le corps. METHODES: la microextraction en phase solide de l'espace de tête (HS­SPME) couplée à la chromatographie en phase gazeuse­spectrométrie de masse (GC­MS) est utilisée pour analyser les parfums résiduels. Nous étudions l'efficacité de l'extraction de diverses fibres SPME et nous comparons différentes méthodes d'échantillonnage des senteurs émises par la peau, y compris le stripping sur ruban adhésif et les entonnoirs en verre scellés. Une procédure contrôlée de lavage du corps est mise en place pour standardiser le processus de nettoyage. RÉSULTATS: nos résultats indiquent que l'écart­type relatif pour mesurer cinq parfums distincts se situe dans la plage de 3% à 14%, ce qui souligne la précision de la méthode. Une variance notable existe dans l'efficacité d'extraction des parfums utilisant différents types de fibres de SPME, certaines présentant plus d'un triplement de différence. En outre, la méthode de l'entonnoir en verre pour la collecte des parfums démontre une sensibilité au galaxolide 11,7 fois supérieure à celle de la méthode de stripping sur ruban adhésif. Les parfums résiduels avec des notes de fond comme principaux composants peuvent être détectés sur la peau jusqu'à 24 h après le lavage du corps. CONCLUSION: la méthode optimisée pour l'évaluation du parfum résiduel développée dans cette étude offre un outil fiable pour analyser les composants du parfum persistant sur la peau jusqu'à 24 heures après le lavage. Cette avancée offre une meilleure compréhension de la longévité des parfums dans les produits de soins personnels, permettant des analyses comparatives entre les différents produits.

A novel description of the supporting system of the orbicularis oculi muscle in the infraorbital area: Tear trough muscle fiber.

BACKGROUND: The aim of this study was to elucidate the anatomical structures of supporting system of the infraorbital area. MATERIALS AND METHODS: Forty-four hemifaces from eleven Korean and eleven Thai cadavers were used to dissect the infraorbital area. Based on the dissection and previous histologic results, they were analyzed. RESULTS: The orbicularis oculi muscle (OOc) had two portions (palpebral and orbital portion) and four subparts (pretarsal, preseptal, prezygomatic, and premaxillary part). The elliptical muscle fiber of OOc was supported by circumferential connective tissue including skin ligament, orbicularis retaining ligament, zygomatic ligament, and zygomatic cutaneous ligament. The vertical muscle fiber, the tear trough muscle fiber, and medial muscular band directly attached to the skin. CONCLUSION: Full of subcutaneous tissue in the tear trough groove, strong attachment to the bone by tear trough ligament and to the skin by tear trough muscle fiber would multiply result in the tear trough on the face.

Socioeconomic and Other Risk Factors for Retear after Arthroscopic Surgery for Nontraumatic Rotator Cuff Tear.

Background and Objectives: Few studies have investigated the socioeconomic factors associated with retear after rotator cuff repair. This study aimed to identify the risk factors, including socioeconomic factors, for rotator cuff retear in patients who underwent arthroscopic rotator cuff repair. Materials and Methods: This retrospective study included 723 patients diagnosed with full-thickness rotator cuff tears who underwent arthroscopic rotator cuff repair from March 2010 to March 2021. The outcome variable was rotator cuff retear observed on postoperative magnetic resonance imaging or ultrasonography. Sex, age, obesity, diabetes, symptom duration, and tear size were the independent variables. Socioeconomic variables included occupation, educational level, type of medical insurance, and area of residence. We compared patients with and without retear and estimated the effects of the independent factors on retear risk. Results: The mean age of the patients, symptom duration, and tear size were 62.4 ± 8.0 years, 1.8 ± 1.7 years, and 21.8 ± 12.5 mm, respectively. The age, type of medical insurance, diabetes, tear size, and symptom duration differed significantly between patients with and without retearing (p < 0.05). Age, occupation, type of medical insurance, diabetes, initial tear size, and symptom duration significantly affected the risk of retear. Patients who performed manual labor had a significantly higher retear rate (p = 0.005; OR, 1.95; 95% CI, 1.23-3.11). The highest retear risk was seen in patients with Medicaid insurance (p < 0.001; OR, 4.34; 95% CI, 2.09-9.02). Conclusions: Age, initial tear size, and symptom duration significantly affect retear risk after arthroscopic rotator cuff repair. Occupation and type of medical insurance were also risk factors for retear. Socioeconomically vulnerable patients may be at a greater risk of retear. Proactive efforts are required to expand early access to medical care.

Usefulness of double plate fixation after failed ORIF for clavicle shaft fracture.

PURPOSE: We aimed to evaluate the clinical and radiological outcomes of double plate fixation for failed clavicle shaft fracture surgery. MATERIALS AND METHODS: We analyzed 14 patients who underwent double plate fixation due to plate failure after clavicle shaft fracture surgery from March 2016 to March 2021. The study used 3.5 mm locking compression plates for superior clavicle and anterior reconstruction in all patients. In addition, moldable allograft bone was used to fill the bone defect. Clinical and radiological evaluation was performed immediately, at 2 and 4 weeks, and 3, 6, 9, and 12 months postoperatively. The visual analog scale (VAS), University of California at Los Angeles (UCLA) shoulder scale, and American Shoulder and Elbow Surgeons (ASES) scores and range of motion of the shoulder were evaluated as clinical results. For radiological evaluation, anteroposterior, caudal, and cephalad views of both clavicles were used. Successful bone union was defined as complete adjoining of the fracture site through callus formation. RESULTS: Successful bone union was achieved in all patients, and the mean time to bone union was 16.7 ± 1.2 weeks (range, 12-24 weeks). Statistically significant improvement in forward flexion and external and internal rotation was observed from 135.5° ± 6.3, 45.2° ± 5.3, and 13° ± 2.3 preoperatively to 157.0° ± 9.3, 68.7° ± 6.3, and 9.8° ± 3.1 at the final follow-up, respectively. The VAS score improved from an average of 6.2 ± 2.8 preoperatively to 1.3 ± 0.7 at the final follow-up, which was statistically significant (P = 0.018). In addition, the ASES score significantly increased from a mean of 52.1 ± 6.3 points preoperatively to 83.6 ± 7.8 points at the final follow-up (P = 0.001). The average UCLA shoulder score was 16.7 ± 1.4 and 31.4 ± 2.2 points preoperatively and at the final follow-up, respectively, which was statistically significant (P = 0.001). CONCLUSION: Double plate fixation has shown good results after failed open reduction and internal fixation (ORIF) for clavicle shaft fractures. Therefore, in complicated situations after ORIF, double plate fixation is considered a surgical treatment option.

Has the core outcome (domain) set for vitiligo been implemented? An updated systematic review on outcomes and outcome measures in vitiligo randomized clinical trials.

BACKGROUND: In 2015, a major achievement in vitiligo research was the development of an internationally agreed upon core outcome domain set for randomized clinical trials (RCTs). Three outcomes were identified as being essential: repigmentation, side-effects/harms and maintenance of gained repigmentation. Four items were further recommended for inclusion. The following recommendations then followed: repigmentation should be assessed by measuring the percentage of repigmentation in quartiles (0-25%, 26-50%, 51-79%, 80-100%) and cosmetic acceptability of the results should be assessed using the Vitiligo Noticeability Scale. OBJECTIVES: The primary objective of this study was to assess uptake of the core outcome domain set for RCTs in vitiligo. Secondary objectives were to update the systematic review on outcomes reported in vitiligo RCTs, and to assess whether repigmentation and cosmetic acceptability of the results were measured using the above-mentioned recommended scales. METHODS: We searched PubMed, Cochrane Library (CENTRAL and Systematic Reviews) and ClinicalTrials.gov for vitiligo RCTs between November 2009 and March 2021. Screening and data extraction were independently performed on title and summary by two researchers. All outcomes and outcome measures reported in eligible RCTs were retrieved and collated. RESULTS: In total, 174 RCTs were identified: 62 were published between 2009 and 2015, and 112 were published between 2016 and 2021.Thirty-eight different outcomes were reported. Repigmentation was the primary outcome in 89% of trials (150 of 169). Forty-nine different tools were used to measure repigmentation. Side-effects and harms were reported in 78% of trials (136 of 174). Maintenance of gained repigmentation was reported in only 11% of trials (20 of 174) and duration of follow-up varied greatly from 1 to 14 months. Cosmetic acceptability of the results and cessation of disease activity were assessed in only 2% of trials (four of 174). Quality of life of patients with vitiligo was assessed in 13% of trials (22 of 174). Finally, only 11 of 112 RCTs (10%) published between 2016 and 2021 reported all three essential core outcome domains (repigmentation, side-effects and maintenance of gained repigmentation) and none of the trials reported both essential and recommended core outcome domains. CONCLUSIONS: Efforts are still needed to close the gap between set recommendations and RCT outcome reporting.

Reliability and agreement testing of a new automated measurement method to determine facial vitiligo extent using standardized ultraviolet images and a dedicated algorithm.

BACKGROUND: Facial repigmentation is the primary outcome measure for most vitiligo trials. The Facial Vitiligo Area Scoring Index (F-VASI) score is often chosen as the primary outcome measure to assess the efficacy of treatments for facial vitiligo. Although useful, this scoring system remains subjective and has several limitations. OBJECTIVES: To assess the agreement and reliability of an algorithmic method to measure the percentage depigmentation of vitiligo on the face. METHODS: We developed a dedicated algorithm called Vitil-IA® to assess depigmentation on standardized facial ultraviolet (UV) pictures. We then conducted a cross-sectional study using the framework of the ERASE trial (NCT04843059) in 22 consecutive patients attending a tertiary care centre for vitiligo. Depigmentation was analysed before any treatment and, for 7 of them, after 3 and 6 months of narrowband UVB treatment combined with 16 mg methylprednisolone, both used twice weekly. Interoperator and interacquisition repeatability measures were assessed for the algorithm. The results of the algorithmic measurement were then compared with the F-VASI and the percentage of depigmented skin scores assessed by 13 raters, including 7 experts in the grading of vitiligo lesions. RESULTS: Thirty-one sets of pictures were analysed with the algorithmic method. Internal validation showed excellent reproducibility, with a variation of < 3%. The percentage of depigmentation assessed by the system showed high agreement with the percentage of depigmentation assessed by raters [mean error (ME) -11.94 and mean absolute error (MAE) 12.71 for the nonexpert group; ME 0.43 and MAE 5.57 for the expert group]. The intraclass correlation coefficient (ICC) for F-VASI was 0.45 [95% confidence interval (CI) 0.29-0.62] and 0.52 (95% CI 0.37-0.68) for nonexperts and experts, respectively. When the results were analysed separately for homogeneous and heterogeneous depigmentation, the ICC for homogeneous depigmentation was 0.47 (95% CI 0.31-0.77) and 0.85 (95% CI 0.72-0.94) for nonexperts and experts, respectively. When grading heterogeneous depigmentation, the ICC was 0.19 (95% CI 0.05-0.43) and 0.38 (95% CI 0.20-0.62) for nonexperts and experts, respectively. CONCLUSIONS: We demonstrated that the Vitil-IA algorithm provides a reliable assessment of facial involvement in vitiligo. The study underlines the limitations of the F-VASI score when performed by nonexperts for homogeneous vitiligo depigmentation, and in all raters when depigmentation is heterogeneous.

Impact of 3-second rule for high confidence assignment on the performance of endoscopists for the real-time optical diagnosis of colorectal polyps.

BACKGROUND: Confusion between high and low confidence decisions in optical diagnosis hinders the implementation of real-time optical diagnosis in clinical practice. We evaluated the effect of a 3-second rule (decision time limited to 3 seconds for a high confidence assignment) in expert and nonexpert endoscopists. METHODS: This single-center prospective study included eight board-certified gastroenterologists. A 2-month baseline phase used standard real-time optical diagnosis for colorectal polyps < 10 mm and was followed by a 6-month intervention phase using optical diagnosis with the 3-second rule. Performance, including high confidence accuracy, and Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) and Simple Optical Diagnosis Accuracy (SODA) thresholds, was measured. RESULTS: Real-time optical diagnosis was performed on 1793 patients with 3694 polyps. There was significant improvement in high confidence accuracy between baseline and intervention phases in the nonexpert group (79.2 % vs. 86.3 %; P = 0.01) but not in the expert group (85.3 % vs. 87.5 %; P = 0.53). Using the 3-second rule improved the overall performance of PIVI and SODA in both groups. CONCLUSIONS: The 3-second rule was effective in improving real-time optical diagnosis performance, especially in nonexperts.

Capillary instability in screen-printed micropatterns.

Screen printing (SP) has been extensively studied owing to its widespread industrial applications; however, only a few studies have focused on the substrate effect. Herein, we demonstrate that a screen-printed line can undergo a broadening effect or lateral undulation, which is determined by the substrate and printed dimensions. The degree of spreading was systematically investigated by employing 1D and 2D geometrical parameters. Based on the liquidity of the ink, we developed a simple inviscid theory with imposed perturbation to analyze the instability of screen-printed lines. The dispersion relation was derived to estimate the geometry of the laterally undulated lines and compared with the experimental results. The proposed argument is particularly applicable to a regime in which SP inks have greater liquidity. The screen-printed patterns exhibited unique undulated shapes and were utilized as photomasks for the facile fabrication of raccoon-type microchannels.

Lateral Lymph Node Size and Tumor Distance From Anal Verge Accurately Predict Positive Lateral Pelvic Lymph Nodes in Rectal Cancer: A Multi-Institutional Retrospective Cohort Study.

BACKGROUND: Lateral pelvic lymph node dissection improves oncological outcomes in rectal cancer patients with suspected lateral pelvic lymph node metastasis. However, the indication for this procedure remains unclear. OBJECTIVE: This study aimed to identify the predictive factors for lateral lymph node metastasis and the indications for lateral pelvic lymph node dissection. DESIGN: A multi-institutional retrospective study. SETTINGS: This study was conducted at 3 university hospitals. PATIENTS: This study involved 105 patients with locally advanced mid/low rectal cancer and clinically suspected lateral pelvic lymph node metastasis who underwent total mesorectal excision with lateral pelvic lymph node dissection between 2015 and 2020. MAIN OUTCOME MEASURES: Indications were set using lateral pelvic lymph node metastasis-associated preoperative factors. RESULTS: Among 105 patients, 36 (34.3%) had pathologically confirmed lateral pelvic lymph node metastasis and 77 (73.3%) underwent preoperative chemoradiation. Tumors located within 5 cm distance from the anal verge ( p = 0.02) and initial node size ≥ 6 mm ( p = 0.001) were significant predictors of lateral pelvic lymph node metastasis. The sensitivity was 100% (36/36) with a cutoff of 6 mm for the initial node size and 94.4% (34/36) with a cutoff of 8 mm for the initial node size. When using initial node size cutoffs of 8 mm for anal verge-to-tumor distance of >5 cm and 6 mm for anal verge-to-tumor distance of ≤5 cm, the sensitivity of lateral pelvic lymph node metastasis was found to be 100%. LIMITATIONS: The retrospective design and small sample size were the limitations of this study. CONCLUSION: Initial node size and tumor height were significant predictors of lateral pelvic lymph node metastasis. This study proposed that an initial node size of ≥8 mm with an anal verge-to-tumor distance of >5 cm and ≥6 mm with an anal verge-to-tumor distance of ≤5 cm are optimal indications for lateral pelvic lymph node dissection in rectal cancer. See Video Abstract at http://links.lww.com/DCR/C101 . EL TAMAO DEL GANGLIO LINFTICO LATERAL Y LA DISTANCIA DEL TUMOR DESDE EL BORDE ANAL PREDICEN CON PRECISIN LOS GANGLIOS LINFTICOS PLVICOS LATERALES POSITIVOS EN EL CNCER DE RECTO UN ESTUDIO DE COHORTE RETROSPECTIVO MULTIINSTITUCIONAL: ANTECEDENTES:La disección de los ganglios linfáticos pélvicos laterales mejora los resultados oncológicos en pacientes con cáncer de recto con sospecha de metástasis en los ganglios linfáticos pélvicos laterales. Sin embargo, la indicación de este procedimiento sigue sin estar clara.OBJETIVO:Nuestro objetivo fue identificar los factores predictivos de la metástasis de los ganglios linfáticos laterales y las indicaciones para la disección de los ganglios linfáticos pélvicos laterales.DISEÑO:Estudio retrospectivo multiinstitucional.AJUSTES:Este estudio se realizó en tres hospitales universitarios.PACIENTES:Este estudio involucró a 105 pacientes con cáncer de recto medio/bajo localmente avanzado y sospecha clínica de metástasis en los ganglios linfáticos pélvicos laterales que se sometieron a una escisión mesorrectal total con disección de los ganglios linfáticos pélvicos laterales entre 2015 y 2020.PRINCIPALES MEDIDAS DE RESULTADO:Las indicaciones se establecieron utilizando los factores preoperatorios asociados con la metástasis de los ganglios linfáticos pélvicos laterales.RESULTADOS:Entre 105 pacientes, 36 (34,3%) tenían metástasis en los ganglios linfáticos pélvicos laterales confirmada patológicamente y 77 (73,3%) se sometieron a quimiorradiación preoperatoria. Los tumores ubicados dentro de los 5 cm desde el borde anal ( p = 0,02) y el tamaño inicial del ganglio ( p = 0,001) fueron predictores significativos de metástasis en los ganglios linfáticos pélvicos laterales. La sensibilidad fue del 100 % (36/36), con un punto de corte de 6 mm para el tamaño inicial del ganglio, seguido de 8 mm para el tamaño inicial del ganglio (94,4%, 34/36). Cuando se utilizó un tamaño de corte inicial del ganglio de 8 mm para una distancia entre el borde anal y el tumor >5 cm y 6 mm para una distancia entre el borde anal y el tumor ≤5 cm, la sensibilidad de la metástasis en los ganglios linfáticos pélvicos laterales fue del 100 %.LIMITACIONES:El diseño retrospectivo y el pequeño tamaño de la muestra.CONCLUSIONES:El tamaño inicial del ganglio y la altura del tumor fueron predictores significativos de metástasis en los ganglios linfáticos pélvicos laterales. Este estudio propuso que un tamaño de ganglio inicial de ≥8 mm con un tumor a >5 cm del margen anal y ≥6 mm con un tumor a ≤5 cm del margen anal son indicaciones óptimas para la disección de los ganglios linfáticos pélvicos laterales en el cáncer de recto. Consulte Video Resumen en http://links.lww.com/DCR/C101 . (Traducción-Dr. Yolanda Colorado ).

Risk of autoimmune skin and connective tissue disorders after mRNA-based COVID-19 vaccination.

BACKGROUND: Data on the association between the development of autoimmune diseases and COVID-19 vaccination are limited. OBJECTIVE: To investigate the incidence and risk of autoimmune connective tissue disorders following mRNA-based COVID-19 vaccination. METHODS: This nationwide population-based study was conducted in South Korea. Individuals who received vaccination between September 8, 2020-December 31, 2021, were identified. Historical prepandemic controls were matched for age and sex in 1:1 ratio. The incidence rate and risk of disease outcomes were compared. RESULTS: A total of 3,838,120 vaccinated individuals and 3,834,804 controls without evidence of COVID-19 were included. The risk of alopecia areata, alopecia totalis, primary cicatricial alopecia, psoriasis, vitiligo, anti-neutrophil cytoplasmic antibody-associated vasculitis, sarcoidosis, Behcet disease, Crohn disease, ulcerative colitis, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren syndrome, ankylosing spondylitis, dermato/polymyositis, and bullous pemphigoid was not significantly higher in vaccinated individuals than in controls. The risk was comparable according to age, sex, type of mRNA-based vaccine, and cross-vaccination status. LIMITATIONS: Possible selection bias and residual confounders. CONCLUSION: These findings suggest that most autoimmune connective tissue disorders are not associated with a significant increase in risk. However, caution is necessary when interpreting results for rare outcomes due to limited statistical power.

Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial.

BACKGROUND: Vitiligo is a chronic autoimmune disorder characterized by depigmented patches of the skin. OBJECTIVE: To evaluate the efficacy and safety of ritlecitinib, an oral JAK3 (Janus kinase)/TEC (tyrosine kinase expressed in hepatocelluar carcinoma) inhibitor, in patients with active nonsegmental vitiligo in a phase 2b trial (NCT03715829). METHODS: Patients were randomized to once-daily oral ritlecitinib ± 4-week loading dose (200/50 mg, 100/50 mg, 30 mg, or 10 mg) or placebo for 24 weeks (dose-ranging period). Patients subsequently received ritlecitinib 200/50 mg daily in a 24-week extension period. The primary efficacy endpoint was percent change from baseline in Facial-Vitiligo Area Scoring Index at week 24. RESULTS: A total of 364 patients were treated in the dose-ranging period. Significant differences from placebo in percent change from baseline in Facial-Vitiligo Area Scoring Index were observed for the ritlecitinib 50 mg groups with (-21.2 vs 2.1; P < .001) or without (-18.5 vs 2.1; P < .001) a loading dose and ritlecitinib 30 mg group (-14.6 vs 2.1; P = .01). Accelerated improvement was observed after treatment with ritlecitinib 200/50 mg in the extension period (n = 187). No dose-dependent trends in treatment-emergent or serious adverse events were observed across the 48-week treatment. LIMITATIONS: Patients with stable vitiligo only were excluded. CONCLUSIONS: Oral ritlecitinib was effective and well tolerated over 48 weeks in patients with active nonsegmental vitiligo.

Immediate urinary catheter removal after colorectal surgery with the enhanced recovery after surgery protocol.

PURPOSE: The Enhanced Recovery After Surgery protocol for colorectal surgery recommends early urinary catheter (UC) removal after surgery. However, the optimal timing remains controversial. We aimed to evaluate the safety of immediate UC removal and risk factors of postoperative urinary retention (POUR) after colorectal cancer surgery. METHODS: From November 2019 and April 2022, patients who underwent elective colorectal cancer surgery at Seoul St. Mary's hospital were collected retrospectively. A UC was inserted in the operating room after general anesthesia and removed in the operating room immediately after surgery. The primary outcome was the occurrence of POUR following immediate UC removal after surgery, and the secondary outcomes were the identification of POUR-related risk factors and postoperative complications. RESULTS: Among 737 patients, 81 (10%) had POUR immediately after UC removal. No patient had urinary tract infection. The incidence of POUR was significantly higher in male and in those with a history of urinary disease. However, there were no significant differences in tumor location, surgical procedure, or approach. The mean operative time was significantly longer in the POUR group. Postoperative morbidity and mortality rates did not differ significantly between two groups. Multivariate analysis showed that risk factors for POUR were male, a history of urinary disease, and intrathecal morphine injection. CONCLUSIONS: Immediate removal of UC immediately after colorectal surgery is safe and feasible in the trend of ERAS. Male, a history of benign prostatic hyperplasia, and intrathecal morphine injection were risk factors for POUR.

Efficacy of oral sulfate tablets for bowel preparation and adenoma detection rate.

BACKGROUND AND AIM: The adenoma detection rate (ADR), which is closely related to bowel preparation, is the most important factor for colonoscopy quality assessment. New oral sulfate tablets (OSTs) have been developed to improve bowel preparation compliance. This study evaluated the efficacy of OSTs in terms of the ADR and bowel preparation status. METHODS: Medical records of subjects under the age of 65 who underwent colonoscopy from March 2019 to February 2021 were retrospectively reviewed. Polyethylene glycol with ascorbic acid (PEG-A) was used as a bowel preparation for the first half of the study period, and OSTs were used for the second half. In total, 16 971 subjects were included in the study: 9199 (54.2%) used PEG-A, and 7772 (45.8%) used OSTs. Bowel cleansing quality was assessed by the Boston Bowel Preparation Scale (BBPS). RESULTS: The average age was 50 years. The rate of adequate bowel preparation was higher in the OST group than in the PEG-A group (97.2% vs 95.0%, P < 0.001). The mean BBPS was also higher in the OST group (8.02 vs 7.75, P < 0.001). The adenomas per colonoscopy (APC), the ADR and the sessile serrated polyp detection rate (SSPDR) were higher in the OST group than in the PEG-A group (APC 0.56 ± 1.01 vs 0.48 ± 0.91, P < 0.001; ADR 34.5% vs 30.7%, P < 0.001; SSPDR 5.2% vs 3.3%, P < 0.001). CONCLUSIONS: Compared with PEG-A, OSTs yielded superior APC, ADRs, SSPDRs, and better bowel cleanliness. Therefore, OSTs are a good alternative for patients who have difficulty taking large-volume bowel preparation formulations.

Pigmented contact dermatitis and hair dyes: A retrospective case-control multicentre study in Korea.

BACKGROUND: Pigmented contact dermatitis (PCD), a rare variant of non-eczematous contact dermatitis, is clinically characterized by sudden-onset brown or grey pigmentation on the face and neck. It is hypothesized to be caused by repeated contact with low levels of allergens. OBJECTIVES: This study evaluated the risk of using hair dyes in patients with PCD in Korea. METHODS: A total of 1033 PCD patients and 1366 controls from 31 university hospitals were retrospectively recruited. We collected and analysed the data from the patient group, diagnosed through typical clinical findings of PCD and the control group, which comprised age/sex-matched patients who visited the participating hospitals with pre-existing skin diseases other than current allergic disease or PCD. RESULTS: Melasma and photosensitivity were significantly more common in the control group, and a history of contact dermatitis was more common in the PCD group. There were significantly more Fitzpatrick skin type V participants in the PCD group than in the control group. There was no significant difference in sunscreen use between the groups. Using dermatologic medical history, Fitzpatrick skin type and sunscreen use as covariates, we showed that hair dye use carried a higher PCD risk (odds ratio [OR] before adjustment: 2.06, confidence interval [CI]: 1.60-2.65; OR after adjustment: 2.74, CI: 1.88-4.00). Moreover, henna users had a higher risk of PCD (OR before adjustment: 5.51, CI: 4.07-7.47; OR after adjustment: 7.02, CI: 4.59-10.74), indicating a significant increase in the risk of PCD with henna dye use. Contact dermatitis history was more prevalent in henna users than in those using other hair dyes in the PCD group (17.23% vs. 11.55%). CONCLUSION: Hair dye use is a risk factor for PCD. The risk significantly increased when henna hair dye was used by those with a history of contact dermatitis.

Worldwide expert recommendations for the diagnosis and management of vitiligo: Position statement from the International Vitiligo Task Force Part 1: towards a new management algorithm.

BACKGROUND: The treatment of vitiligo can be challenging and depends on several factors such as the subtype, disease activity, vitiligo extent, and treatment goals. Vitiligo usually requires a long-term approach. To improve the management of vitiligo worldwide, a clear and up-to-date guide based on international consensus with uniform stepwise recommendations is needed. OBJECTIVES: To reach an international consensus on the nomenclature and to develop a management algorithm for the diagnosis, assessment, and treatment of vitiligo. METHODS: In this consensus statement, a consortium of 42 international vitiligo experts and four patient representatives participated in online and live meetings to develop a consensus management strategy for vitiligo. At least two vitiligo experts summarized the evidence of topics included in the algorithms. A survey was utilized to resolve remaining issues among a core group of eight experts. Subsequently, the unanimous recommendations were finalized and validated based on further input from the entire group during two live meetings. RESULTS: The algorithms highlight the importance of shared decision-making. Dermatologists are encouraged to provide patients with detailed explanations of the prognosis and expected therapeutic outcomes based on clinical examination. The treatment goal should be discussed and clearly emphasized to patients given the different approaches for disease stabilization and repigmentation. The evaluation of disease activity remains a cornerstone in the tailor-made approach to vitiligo patients. CONCLUSIONS: These new treatment algorithms are intended to guide clinical decision-making in clinical practice. Promising novel therapies for vitiligo are on the horizon, further highlighting the need for reliable outcome measurement instruments and greater emphasis on shared decision-making.