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Ayer — Octubre 2nd 2025Tus fuentes RSS

Investigation of prophylactic clip haemorrhage control for colorectal cold snare polypectomy in patients taking antithrombotic drugs (PERCOLD): study protocol--a multicentre prospective parallel-group non-inferiority RCT phase 3 trial

Por: Okimoto · K. · Matsumura · T. · Taida · T. · Ishikawa · T. · Koshibu · Y. · Shu · N. · Ozeki · Y. · Furuya · M. · Mamiya · Y. · Nakazawa · H. · Ohyama · Y. · Takahashi · S. · Horio · R. · Goto · C. · Kurosugi · A. · Sonoda · M. · Kaneko · T. · Ohta · Y. · Matsusaka · K. · Inaba · Y. · Kato · J.
Introduction

The effect of prophylactic clipping for colorectal cold snare polypectomy (CSP) on delayed bleeding (DB) in patients with antithrombotic drugs remains unverified. The aim of the PERCOLD study is to demonstrate the non-inferiority of DB rates in cases without prophylactic clips compared with cases with prophylactic clips in patients taking antithrombotic drugs for colorectal CSP through randomised controlled trial (RCT).

Methods and analysis

This study is a multicentre prospective parallel-group RCT phase 3 trial that is being conducted at 14 institutions in Japan at the time of writing this manuscript. After providing consent, patients will undergo screening and assessment for study enrolment eligibility. Patients taking antithrombotic drugs (aged 20 years or older at the time of consent and who have agreed to participate in this study) will be selected if they have a preoperative suspected adenoma (including sessile serrated lesion) with an endoscopic diameter of

Ethics and dissemination

The trial protocol has been approved by the Chiba University Certified Clinical Research Reviewer Board (CRB3180015), which serves as the central ethics committee, and registered with Japan Registry of Clinical Trials. The current protocol V.1.7, dated 4 October 2024. Written informed consent for participation in the study will be obtained from all participating patients. All participating institutions have formally agreed to conduct the study in accordance with this central approval, and local site permissions were obtained as required by each institution. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.

Trial registration number

Japan Registry of Clinical Trials (jRCT1032230086).

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Perampanel for alleviation of secondary injury in traumatic brain injury (PEACE-TBI): a protocol for a phase-II multicentre randomised clinical trial

Por: Yamamoto · R. · Tamura · R. · Morimoto · Y. · Nakaya · M. · Terao · S. · Shoji · T. · Kanazawa · T. · Sasao · R. · Inaba · M. · Shimizu · M. · Kuranari · Y. · Katayama · M. · Ueno · K. · Oishi · Y. · Nakamura · A. · Kikuo · Y. · Murakami · R. · Homma · K. · Wakahara · S. · Ishikawa · K. · Kosu
Introduction

Traumatic brain injury (TBI) often causes permanent neurological dysfunction. Although no medication has been validated yet to prevent secondary injury of brain tissue, recent animal studies have reported that perampanel, a glutamine receptor antagonist, could improve the neurological functions of animals with TBI by mitigating the abnormal calcium influx and cell death around the site of primary injury. The present study aims to elucidate the efficacy of perampanel administration in improving the neurological function of patients with TBI.

Methods and analysis

The perampanel for alleviation of secondary injury in TBI trial is a multicentre, phase-II, open-label randomised controlled trial targeting patients with mild-to-moderate TBI. This trial will include adult TBI patients with a Glasgow Coma Scale score of 9–14 from five tertiary centres. Patients with epilepsy as a comorbidity, delayed presentation of symptoms (>24 hours after injury) or Injury Severity Score of ≥25 will be excluded. The study participants will be randomly assigned to either the perampanel group (2 mg/day) or the control group (fosphenytoin administered at a dose of 15–18 mg/kg/day, followed by 5–7.5 mg/kg/day of fosphenytoin). In both groups, the medication will be initiated within 12 hours of the TBI diagnosis and continued for 7 days. The antiepileptic drugs can be increased, changed or added as necessary if early post-traumatic seizures are observed. The primary outcome is favourable neurological outcome, defined as a Glasgow Outcome Scale Extended score of ≥5 at 90 days after the TBI diagnosis, which will then be compared between the groups through an intention-to-treat analysis.

Ethics and dissemination

The present study has been approved by the Certified Review Board of Keio at the principal institution (approval number: N20240004). Written informed consent will be obtained from all participants or their legal representatives. The results will be disseminated via publications and presentations.

Trial registration number

Japan Registry of Clinical Trials (jRCTs031250067).

Association between the use of an app for providing healthcare information for parents and urgent emergency department visits for children: a cross-sectional study in Japan

Por: Sakamoto · M. · Suzuki · A. · Ishikawa · H.
Objective

To evaluate the association between the use of medical information applications and urgent emergency room consultation behaviour among parents who visited the emergency department (ED) of their children.

Design

Cross-sectional survey.

Setting

A primary-level paediatric emergency medical facility in Nagano Prefecture.

Participants

Parents of children aged 8 years or younger who had visited the medical facility between December 2023 and March 2024.

Primary and secondary outcome measures

The primary outcome was defined as an association between the urgency of ED visits and parental use of mobile applications. The secondary outcome was the association between the urgency of ED visits and app evaluations among parents using the app. The urgency of the ED visits was classified according to the Japan Triage and Acuity Scale.

Results

In total, 386 parents participated in this study (response rate: 91%). Among these, 77% were mothers and the median age was 36.3 years. Of the ED visits by app users, 63.7% were classified as urgent, compared with 41.7% of visits by non-users (adjusted OR: 2.8, 95% CI: 1.7 to 4.7, p

Conclusions

The use of the medical information app was significantly associated with parental ED urgency. These findings suggest that such apps may support informed decision-making in paediatric emergency care. Future research should investigate the effect of this app on a broader population, including cases involving ambulance transport.

Short sleep duration is a significant risk factor of obesity: A multicenter observational study of healthy adults in Japan

by Mami Takahashi, Takeshi Shimamoto, Lumine Matsumoto, Yusuke Mitsui, Yukari Masuda, Hirotaka Matsuzaki, Eriko Hasumi, Chie Bujo, Keiko Niimi, Takako Nishikawa, Ryoichi Wada, Nobutake Yamamichi

This multicenter study aimed to elucidate the association between sleep duration and various lifestyle-related disorders in healthy adults in Japan. A total of 62,056 healthy participants (age: 49.4 ±  10.9 years) who received medical checkups from 2010 to 2020 were analyzed cross-sectionally and longitudinally. The mean sleep duration was 6.2 ±  1.0 h in men and 6.1 ±  1.0 h in women. The distribution of sleep duration showed that older people tended to sleep longer, which was clearly observed in men but not in women. Univariate analyses showed that older age, lower body mass index (BMI), habitual drinking, and habitual exercise were significantly associated with longer sleep duration. Multivariate analyses in men showed that sleep duration was positively associated with age, habitual exercise, serum triglyceride (TG), systolic blood pressure (SBP), and habitual drinking and negatively associated with BMI and hemoglobin A1c (HbA1c). Alternatively, in women, sleep duration was positively associated with habitual exercise and TG and negatively associated with BMI, high-density lipoprotein-cholesterol, HbA1c, and current smoking. During the follow-up period, 3,360 of 31,004 individuals (10.8%) developed obesity. The Cox proportional hazards model showed that shorter sleep duration was a significantly higher risk of obesity, and longer sleep duration might be a lower risk of obesity. On the other hand, 1,732 of 39,048 participants (4.4%) developed impaired glucose tolerance, and 6,405 of 33,537 participants (19.1%) developed hypertriglyceridemia. However, the Cox proportional hazards model did not show significant association between sleep duration and impaired glucose tolerance or hypertriglyceridemia. In conclusion, our large-scale cross-sectional study showed that sleep duration was positively associated with habitual exercise and TG and negatively associated with BMI and HbA1c, regardless of sex. Longitudinal analysis revealed that shorter sleep duration is a significant risk factor for obesity.

Effectiveness of SCAR‐Q for assessment of incisional SCAR after implant‐based reconstruction in breast cancer patients: Can it be a tool for incision selection?

Abstract

Incisional scarring is a factor of cosmetic appearance evaluated after breast reconstruction, along with the shape, position, and size of the breast. This study aimed to examine the effect of the incision scar location on patient satisfaction after breast reconstruction. Using the Japanese version of the SCAR-Q, we assessed the scar appearance, symptoms and psychosocial effects. Plastic surgeons performed assessments using the Manchester Scar Scale. The patients were divided into two groups: those with scars on the margins of the breast (MB group) and those with scars in the breast area (IB group). The results revealed that patients in the MB group reported significantly higher satisfaction with the scar appearance and psychological impact than those in the IB group. However, assessments using the Manchester Scar Scale did not reveal any significant differences between the two groups. In conclusion, this study underscores the importance of patient-reported outcomes in the evaluation of scar satisfaction after breast reconstruction. Patients tend to prefer and have higher satisfaction with scars along the breast margin, which offers valuable insights into surgical decisions. Further studies with larger and more diverse sample sizes are required for validation.

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