Prostate cancer is one of the most prevalent malignancies among men, with early and accurate diagnosis is essential for optimizing clinical outcomes. The Trinetra-ProstateTM study is a prospective multicenter observational trial designed to evaluate the diagnostic performance of a novel blood-based test for detection of clinically significant prostate cancer. The test, developed by Datar Cancer Genetics, identifies circulating tumor cells (CTCs) in peripheral blood and is assessed against standard diagnostic modalities, including multiparametric magnetic resonance imaging and prostate biopsy. The primary objective of this study is to determine the sensitivity and specificity of the CTC assay for detecting cancer in men with elevated prostate-specific antigen levels and/or abnormal digital rectal examinations. Secondary objectives include assessing concordance with histopathological findings, potential to reduce unnecessary biopsies, and integration with existing diagnostic pathways. The study aims to enroll 250 men aged 45–75 years across multiple centers, applying the defined inclusion and exclusion criteria to ensure methodological rigor. The protocol includes detailed procedures for blood sampling, imaging, biopsy, and data analysis. Ethical approval was obtained and data protection measures are in place in accordance with international research standards. If validated, the CTC-based assay may offer a noninvasive and accurate alternative to current diagnostic approaches, improving patient stratification and reducing the burden of invasive procedures in prostate cancer diagnostics.

Introduction:There are multiple surgical options such as fistulotomy and fistulectomy to treat anal fistula (AF), yet treatment failure rates can be as high as 50%. In 1976, Parks et al classified AF into inter-sphincteric, trans-sphincteric, supra-sphincteric, and extra-sphincteric based on sphincter anatomy. This system overlooks complex features, which prompted Emile et al to incorporate risk factors into a modified version. In this retrospective cohort study, the external validity of this new classification will be investigated.Methods:A retrospective cohort design will be used and patients with cryptoglandular anal fistula who had preoperative MRI will be consecutively enrolled. Patients will be categorized according to the modified Parks classification. We will use descriptive analysis to describe imaging and clinical data. Moreover, logistic regression will be employed to develop a predictive model for recurrence. A P <0.05 will be considered significant, and the results will be reported with 95% confidence intervals (CI), if applicable. The study was approved by the institutional ethics committee.Discussion:Patient with cryptoglandular AF often experience recurrent disease. Modified Parks classification integrates risk factors to guide management. This retrospective study is the first to externally validate Parks classification using MRI findings.

Introduction:For evidence-based healthcare decisions, systematic reviews are essential, yet data extraction errors, often overlooked, pose a substantial threat. In the field of urology, there has been a notable increase in the number of reviews that are not subject to rigorous examination. This study pioneers a shift, investigating data reproducibility issues in urological systematic reviews, highlighting the critical need for scrutiny in evidence synthesis.Methods:This study examines data extraction errors in systematic reviews from 58 urology journals indexed in PubMed and Embase. Systematic reviews that include meta-analyses with randomized controlled trials will be selected. Data extraction will be carried out independently by two reviewers using standardized forms, followed by cross-verification with original sources. Errors will be categorized at the review, meta-analysis, and study levels. Statistical analyses will evaluate the prevalence of these errors and their impact on meta-analytic results. Sensitivity analyses will explore the effect of missing data on the study outcomes.Discussion:This study addresses the often-overlooked issue of data extraction errors in urology systematic reviews, which could impact the reliability of evidence-based decisions. By evaluating the reproducibility of data extraction, the study aims to enhance methodological rigor in urological reviews and improve the validity of conclusions drawn from evidence synthesis. Despite its limitations, this research will contribute valuable insights into the quality of systematic reviews and guide future improvements in evidence-based practice.

Background:Patients who undergo gastrectomy for gastric cancer experience gastrointestinal symptoms, psychological responses, and social problems. These factors reduce a patient’s quality of life (QoL) after surgery. A web-based platform (Wecare®) has been developed to address distress and provide solutions. This study aimed to evaluate whether Wecare® improved the QoL of patients who underwent gastrectomy.Methods:A total of 88 patients who undergo gastrectomy for gastric cancer will be randomly allocated to either the “Wecare®” group or the control group at a 1:1 ratio. After using the “Wecare®” platform for the first 22 patients and making modifications, the next 66 patients will be randomized equally. The primary outcome of this trial is the QoL among gastric cancer survivors (KOQUSS-40). The values of weight change, nutritional index change, KOQUSS-40 questionnaire compliance, self-efficacy, physical activity change, and satisfaction will be compared between the two groups as secondary outcomes. The investigator will follow-up with the patients at 1, 3, and 6 months after surgery at the outpatient clinic.Discussion:This is the first randomized controlled trial to analyze the usefulness of a symptom management platform (Wecare®) among gastric cancer survivors. This study aimed to verify the efficacy of web-based platforms in relieving discomfort after gastric cancer surgery. Future large-scale clinical trials are planned.

Introduction:Water-Jet (WJ) dissection is an innovative technique for liver surgery that uses high-pressure saline jets to selectively dissect liver parenchyma while preserving vascular and biliary structures. Compared to the Cavitron Ultrasonic Surgical Aspirator (CUSA), WJ offers advantages such as reduced thermal damage, lower blood loss, and shorter operative times. These benefits are particularly important in living-donor liver transplantation (LDLT), where donor safety and rapid recovery are critical. This WORLD trial (“W”ater-Jet versus CUSA f“o”r Liver Pa“r”enchymal Transection in “L”iving “D”onor Liver Transplantation) aims to compare the efficacy and safety of WJ and CUSA in LDLT.Methods and analysis:This single-blind, randomized controlled trial will include 48 living liver donors, allocated in a 1:1 ratio to the WJ or CUSA group. Experienced surgeons will perform liver parenchymal transection using standardized protocols. The primary endpoint is transection speed (cm2/min), with secondary outcomes including operative time, blood loss, complication rates, length of postoperative hospital stays, and postoperative liver function tests. Statistical analysis will assess the non-inferiority of WJ using JMP and R software, with a one-sided α of 2.5% and 80% power.Ethics and dissemination:This study protocol was approved by the institutional review board of Kyushu University (No. 20232001). The study is registered in UMIN-CTR as UMIN000051662. Written informed consent will be obtained from all participants. The results will be published in a peer-reviewed journal and will be presented at medical meetings.

Background:Neurogenic thoracic outlet syndrome (NTOS), characterized by brachial plexus compression, causes chronic pain and numbness in the upper extremities. Recurrences are common after surgical treatment, which typically includes an anterior scalenectomy and rib resection. Brachial plexus neurolysis and flap coverage can reduce scar fibrosis and prevent further recurrence. The latissimus dorsi flap is a common choice for this purpose. However, perforator fat flaps minimize donor site complications by avoiding muscle harvesting. Furthermore, a free flap transfer prevents new scars from developing in an already painful anatomical region. Given the lack of literature on this subject, we plan to use validated and recommended questionnaires to investigate the impact on pain and quality of life of brachial plexus wrapping with a free fat flap following neurolysis in cases of recurrent NTOS.Methods:FIRST is a single-center, prospective observational pilot study recruiting participants over 24 months. Eligible patients over the age of 18 are treated with brachial plexus neurolysis and a free perforator fat flap for recurrent NTOS. The study aims to enroll 20 patients and involves preoperative and postoperative assessments at a six-month follow-up. The primary outcome, measured using numerical scales, is pain reduction. Secondary outcomes include decreased painful body surface area, maximum and average pain levels, changes in quality of life, upper limb function, and anxiety-depressive symptoms, which are measured using various validated scales and questionnaires.Discussion:This study will provide insight into the efficacy of free perforator fat flaps in recurrent NTOS using standardized, validated assessments for neuropathic pain, including psychosocial aspects. By providing vascularization around the brachial plexus, fat flaps may reduce inflammation, fibrosis, and perineural scar adhesions, thereby alleviating pain. This technique also avoids extensive local dissection required for regional flaps and reduces donor site morbidity. Potential limitations include the technical complexity of free flap surgery.

Background:End-to-end anastomosis to the internal mammary artery (IMA) is the current standard anastomosis technique for women undergoing autologous breast reconstruction with deep inferior epigastric perforator (DIEP) flap. This approach fails to preserve the length of the IMA, compromising its availability for cardiac surgery use in women who develop coronary heart disease. A viable alternative may be end-to-side anastomosis, but data on its feasibility is currently lacking.Methods:This pilot study will involve 60 patients at a single-center institute over approximately 24 months. Inclusion criteria are female sex, age >18 years, history of breast cancer, and eligibility for unilateral autologous DIEP breast reconstruction. Exclusion criteria include patients with a legal guardian, inability to consent, and history of blood clotting disorders or hypercoagulability. Data will be collected at 2 weeks, 6 weeks, 6 months, and 1-year post-surgery. The primary outcome is “major complication” of the recipient site, including anastomotic insufficiency, arterial thrombosis, hematoma, reoperation, or flap loss. Secondary outcomes are abdominal perfusion and major donor site complications, such as wound healing disorders. Patient satisfaction will be assessed using the SF-36 and BREAST-Q (reconstructive module) questionnaires.Study status:The DIEP-ES study has begun enrolment in February 2023. As this is an ongoing trial, no results have been gathered yet. The results will be reported upon completion of the study. We anticipate that the primary and secondary outcomes of the end-to-side approach will be comparable to the accepted standard of care, i.e., end-to-end anastomoses.Conclusions:End-to-side anastomosis may be a safe alternative for DIEP breast reconstruction, especially for patients at risk for coronary heart disease. This pilot study aims to evaluate the feasibility and safety of the end-to-side anastomosis technique in DIEP-flap breast reconstruction. The preliminary findings will inform the design of future multicentric trials to confirm the efficacy of this approach.

Presently, there is a growing popularity of assisted reproductive technology (ART). Nevertheless, due to the significant fluctuations in reproductive hormone levels observed in patients receiving this novel technology, concerns have been raised regarding the potential increased risk of breast cancer associated with this treatment. The outcomes of pertinent clinical investigations exhibit significant disparities, leading to a lack of consensus regarding the association between ART and susceptibility to breast cancer. The primary objective of this study is to systematically evaluate the impact of ART on the risk of breast cancer. The study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis and Meta-analysis Guidelines for Observational Studies in Epidemiology guidelines. Researchers conducted an extensive electronic search across databases including PubMed, Web of Science, Embase, and the Cochrane Library, encompassing all articles published over the last two decades (from January 2003 to December 2023). Two independent researchers meticulously examined the titles and abstracts of the literature based on predetermined inclusion criteria and research qualifications. Through collaborative deliberation, they identified the literature to be incorporated in the following analysis. Researchers will extract data in accordance with predetermined tables and perform quality assessments and implement bias control measures for each literature. Researchers will conduct a meta-analysis based on the extracted data to assess the overall risk and subgroup risks. The analysis will employ the odds ratio as the summary statistic and will use fixed or random effects models for estimation. The findings of this systematic review will be disseminated through publication in peer-reviewed journals and presentation at international medical conferences, with the aim of reaching both medical professionals and the general public. As this study constitutes a systematic review, ethical approval is not required.

Introduction: Compared to conventional colon cancer surgery, laparoscopic complete mesocolic excision (CME) increases the likelihood of lymph node dissection. However, this surgery is not yet considered a safe strategy. The authors study this topic to evaluate the safety and feasibility of this surgery. Methods: A prospective cohort study was performed on patients undergoing laparoscopic CME surgery at the Hue University of Medicine and Pharmacy Hospital and Hue Central Hospital. Results: Demographic data, surgical features, and postoperative complications. Evaluate different clinicopathological factors determining the number and distribution of lymph nodes; and the rate of lymph node metastasis by tumor location and lymph node groups. Three-year overall survival and disease-free survival follow-up after surgery. Conclusion: The results of laparoscopic CME colectomy surgery are safe, with a reliable maximum number of harvested nodes.

Pneumoperitoneum - free air within the peritoneal cavity - is often the result of bowel perforation, though other causes include residual postprocedural or postoperative air and barotrauma. In non-cancer patients, operative intervention is often required. Cancer patients, on the other hand, present a unique set of challenges as they usually have elevated risk of pneumoperitoneum from local radiation therapy, frequent endoscopic procedures, and tumor invasion. Factors such as malnutrition, neutropenia, chemotherapy, and steroid use make emergent surgery tenuous in cancer patients. There is a paucity of published literature on the management of pneumoperitoneum in patients actively undergoing chemotherapy. The main objective of this scoping review is to assess the presentation, management, and subsequent outcomes of this unique patient population. The authors will utilize the framework for performing scoping reviews as outlined by Arksey and O'Malley. They will perform the search for articles in three electronic databases (i.e. SCOPUS, PubMed, Embase) and relevant gray literature. Only articles available in English and published between 1999 and 2022 will be included. Inclusion criteria will be a known diagnosis of cancer, chemotherapy within 6 months of presentation, and imaging confirmation of pneumoperitoneum. Exclusion criteria will be cancer diagnosis at the time of presentation, perforation secondary to cancer itself, and chemotherapy greater than 6 months prior to presentation. A tailored extraction frame to extract relevant information from published articles that meet our inclusion criteria. The data using both descriptive statistics and thematic analysis of the main study questions. Since the authors will not be collecting primary data, formal ethical approval is not required. They study findings will be disseminated through abstracts, conference presentations, and peer-reviewed publications.