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Total mesorectal excision has been adopted as standard procedure for resectable rectal cancer. However, there is no regulation in the current guidelines on the sequence of ligation of the inferior mesenteric artery and vein during rectal cancer surgery owing to a lack of sufficient evidence. Circulating tumour cells (CTCs) in peripheral blood can be used as potential indicators for predicting postoperative recurrence and prognosis in patients with colorectal cancer. The aim of the study is to investigate whether vascular ligation sequence affects the dissemination of CTCs into the bloodstream and survival during minimally invasive rectal cancer surgery.
This study is a prospective, multicentre, randomised controlled trial investigating the effect of ligation sequence (inferior mesenteric artery vs vein priority) on CTC levels and survival outcomes in minimally invasive rectal cancer surgery. 268 eligible patients with rectal cancer will be randomly assigned to the priority ligation of the inferior mesenteric vein group or priority ligation of the inferior mesenteric artery group during minimally invasive rectal cancer surgery. The primary endpoint of this study is the change of peripheral blood CTC levels before and after surgery, analysed using the Wilcoxon rank sum test. Secondary endpoints are 3-year disease-free survival, 3-year overall survival, 3-year recurrence pattern, intraoperative blood loss, operation duration, conversion rate, number of lymph nodes collected, intraoperative morbidity and mortality, postoperative morbidity and mortality and postoperative recovery course.
The study has been approved by the ethics committee of Sichuan Cancer Hospital (Approval number: SCCHEC-02-2024-102), all participants of the study will be well informed and written informed consent will be obtained from all participants. Findings from this trial will be published in peer-reviewed publications.
High-intensity statin therapy is recommended as a first-line strategy for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with acute myocardial infarction (AMI). A combination of moderate-intensity statin and ezetimibe at an equivalent dose to high-intensity statin may achieve similar LDL-C reduction with fewer side effects. This study evaluates the long-term efficacy and safety of this approach, initiated following AMI, compared with high-intensity statin monotherapy.
The ROSUZET-AMI trial is a multicentre, prospective, open-label, randomised, non-inferiority trial. Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint is the composite of cardiovascular death, major coronary events (non-fatal myocardial infarction, documented unstable angina requiring hospitalisation and all coronary revascularisation events occurring at least 30 days after randomisation), or non-fatal stroke.
Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary’s Hospital (No. 2020-0424-0003). Informed consent is obtained from every participant before randomisation. 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.
Recurrent in-stent restenosis (RISR) remains a major therapeutic challenge in patients undergoing percutaneous coronary intervention (PCI), with a high incidence of repeat revascularisation and increased mortality. Immune-mediated inflammation has been implicated in the pathogenesis of RISR. This trial aims to evaluate the clinical efficacy and safety of two anti-inflammatory strategies—low-dose colchicine and prednisone—on reducing ISR recurrence and cardiovascular events.
This is a multicentre, prospective, randomised, open-label controlled trial enrolling 252 patients with RISR. Following successful PCI, patients are randomly assigned (1:1:1) to receive: (1) standard medical therapy (control group); (2) colchicine 0.5 mg/day (colchicine group) or (3) prednisone 0.5 mg/kg/day, tapered monthly to 5–10 mg/day over 12 months (prednisone group). All groups receive background standard therapy per guidelines. The primary endpoint is angiographically confirmed ISR of the target lesion at 12 months post PCI. Secondary endpoints include the incidence of major adverse cardiovascular and cerebrovascular events (cardiovascular death, myocardial infarction, stroke and target vessel revascularisation), target lesion revascularisation and revascularisation of non-target coronary lesions within 12 months.
This trial has received ethical approval from the Ethics Committee of Fuwai Hospital (Chinese Academy of Medical Sciences and Peking Union Medical College), which acts as the central institutional review board. All participants will provide written informed consent. Study results will be disseminated via peer-reviewed journals and conference presentations.
ClinicalTrials.gov, NCT06090890. Registered 15 October 2023,
Prophylactic ileostomy plays a critical role in the radical resection of low rectal cancer, but the incidence of stoma site incisional hernia (SSIH) after stoma closure remains high. No study has been reported in which radiomics has been used to predict SSIH. The primary aim of this study is to evaluate the safety and efficacy of biological mesh in preventing incisional hernia in patients with high-risk incisional hernia factors, as identified by image-based deep learning model, undergoing ileostomy closure surgery.
40 patients who need to undergo ileostomy closure and have been identified with high risk factors for SSIH by image-based deep learning model will be selected for this study. Patients will be randomly assigned equally to the prophylactic biological mesh placement group and the control group, and outcomes will be tracked via clinic review at 1 month, 3 months, 6 months and 12 months postoperatively. The outcome measures are the rate of postoperative incisional hernia, local pain, incisional infection, seroma and so on. This study demonstrates that prophylactic placement of biological mesh with ileostomy closure reduces the incidence of SSIH. Furthermore, it validates the feasibility of image-based deep learning models in predicting postoperative complications and identifying high-risk SSIH patients.
Informed consent has been obtained from all subjects. This protocol has been approved by the Ethics Committee of Renji Hospital, Shanghai Jiao Tong University School of Medicine (KY2022-087-B). The findings will be disseminated through peer-reviewed manuscripts, reports and presentations.
ChiCTR2200064995. Registration date: October 2022. Registration authority: Chinese Clinical Trial Registry.
Overactive bladder (OAB) is a common condition, affecting approximately one-fifth to one-sixth of the world’s population. The American Urological Association and the Society of Urodynamics, Female Pelvic Medicine and Genitourinary Reconstruction guidelines recommend sacral neuromodulation (SNM) as third-line treatment. Although SNM can relieve the symptoms of refractory OAB, several factors, including high cost and the high incidence of adverse effects, limit its large-scale clinical use. Moreover, patient acceptance is low. Acupuncture is an alternative approach for treating OAB that is minimally invasive and has few side effects. Clinical studies have shown that it can reduce the number of episodes of urination and urgent urination within 24 hours and improve the quality of life. However, clinical evidence on the effectiveness of electroacupuncture for treating refractory OAB is limited.
Is to assess the short-term effectiveness of electroacupuncture for improving the symptoms and quality of life of women with refractory OAB and to observe its long-term effects. A secondary objective is to assess whether electroacupuncture is more effective than conventional acupuncture for treating patients with refractory OAB.
The study is designed as a two-arm, parallel, participant-blinded randomised controlled trial (RCT). A total of 60 women between the ages of 18 years and 60 years who are experiencing refractory OAB will be randomly assigned to two groups: one receiving electroacupuncture and the other receiving conventional acupuncture. Each participant will undergo a treatment regimen lasting 4 weeks. During the initial 2 weeks, participants will receive five sessions of either electroacupuncture or conventional acupuncture per week, followed by three sessions per week during the subsequent 2 weeks. In total, each individual will receive 16 treatment sessions throughout the course of the study. The primary outcome measure will be the change in OAB Symptom Score (OABSS) over time between groups. The secondary outcome measures will include the OABSS, the Patient-Perceived Bladder Symptom Grading Scale, the Overactive Bladder Questionnaire, the Self-Rating Anxiety Scale and the Self-Rating Depression Scale during the treatment and follow-up periods. Blinding and safety will also be assessed. Two-sided p values
The study protocol was approved by the Institutional Review Board of Beijing Fengtai Hospital of Integrated Traditional and Western Medicine on 5 February 2024 (Approval No. 2024020101). The results will be disseminated through presentations at scientific conferences and peer-reviewed publications.
ChiCTR2400081448.
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