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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).
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
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.
Japan Registry of Clinical Trials (jRCT1032230086).
To examine the relationship between weight loss and problems with oral intake in institutionalised older adults.
A 1-year longitudinal observational study.
Data were obtained from a prospective study conducted in three nursing homes and two long-term care facilities in Japan. Participants' problems with oral intake were assessed using items published in 2021 by the Japanese Ministry of Health, Labour and Welfare. Baseline and follow-up factors were compared between individuals who experienced a weight loss of 5% or more and those who did not. Separate multivariable logistic regression models were constructed for each oral intake assessment item to examine its independent association with weight loss of 5% or more, accounting for transitions in each item between baseline and the 1-year follow-up.
In total, 172 institutionalised older adults were included in the analysis. Among them, 57 (33.1%) participants experienced a weight decrease of 5% or more. The emergence of somnolence or clouding of consciousness during meals at the 1-year follow-up in participants without these signs at baseline was independently associated with a weight loss of 5% or more, after adjustment for baseline characteristics.
Recognising signs of somnolence or clouding of consciousness during meals may be useful for the early detection and prevention of weight loss in institutionalised older adults.
Early detection of individuals at risk is essential to prevent significant weight loss and its associated adverse outcomes. Recognising somnolence or clouding of consciousness during meals may enable earlier detection and intervention to prevent weight loss and improve the quality of care for older adults.
Strengthening the Reporting of Observational Studies in Epidemiology.
No patient or public contribution.
To investigate the association between self-stigma evaluated using the Japanese version of the Self-Stigma Scale (SSS-J) and diabetic complications, such as diabetic retinopathy (DR) and diabetic kidney disease (DKD).
Cross-sectional study.
One university hospital and one clinic in Fukuoka, Japan.
People (age ≥20 years) with type 2 diabetes receiving outpatient care, who were treated by diabetologists, and completed the SSS-J questionnaire (n=259).
The primary outcome was the level of self-stigma assessed using the SSS-J. The presence of DR and DKD was evaluated as secondary outcomes.
A positive correlation was found between self-stigma and glycated haemoglobin (HbA1c) levels (r=0.132, p=0.034). The mean SSS-J score was significantly higher in people with type 2 diabetes who had DR than in those without DR (p=0.006). There was no significant difference in the mean SSS-J scores of the patients with albuminuria (p=0.318) or a decreased kidney function (p=0.887). Additionally, the relative risk for the presence of DR, as assessed by quartiles of SSS-J scores and a logistic regression analysis, was significantly increased in the Q4 group with the highest SSS-J score after adjustment for sex, age and HbA1c (OR=3.91, 95% CI 1.49 to 10.3, p=0.006). The relative risk for the presence of albuminuria as a DKD significantly increased in the Q4 group immediately after adjustment for sex and age (OR=2.45, 95% CI 1.04 to 5.81, p=0.042). However, this association was attenuated and became non-significant after additional adjustment for HbA1c levels. In contrast, no significant association was observed between the SSS-J score quartiles and decreased kidney function.
The presence of DR was more strongly associated with self-stigma than DKD. Although the causality between self-stigma and the presence of DR could not be elucidated due to the cross-sectional nature of the study, the present study suggests that addressing self-stigma may aid in glycaemic management and the prevention of DR, emphasising the need for healthcare providers to recognise self-stigma as a barrier to optimal diabetes care.
FreshRSS 