International Journal of Surgery Protocols最新文献

Introduction: Focal therapy (FT) for localized prostate cancer (PC) aims to achieve cancer control and maintain quality of life. Microwave tissue coagulation (MTC) is a tissue-coagulation thermotherapy that has been used to treat solid tumors such as kidney, liver, and lung tumors. However, the use of this technology in lesion-targeted FT for PC has not been established.

Methods: We will perform a prospective multi-center, single-arm, clinical study to evaluate the efficacy and safety of lesion-targeted focal MTC for localized PC. In eight centers with expert urologists for performing magnetic resonance imaging (MRI)/ultrasound (US) fusion biopsy, patients will be evaluated prospectively after lesion-targeted MTC. The target sample size is 65. This study was registered with the Japan Registry of Clinical Trials and ClinicalTrials.gov. Inclusion criteria were patients who had a single MRI-visible lesion with Prostate Imaging Reporting and Data System (PI-RADS) category 3 or 4 that was proven as Gleason score of 7 or 8 cancer by enrollment biopsy or patients who had a single MRI-visible lesion with PI-RADS category 4 or 5 that was proven as Gleason score of 6 or 7 by enrollment biopsy. The primary endpoint is the disappearance of the targeted cancer lesion at 6 months after microwave coagulation, evaluated by a combined response in prostate-specific antigen, MRI, and prostate biopsy.

Discussion: The importance of this clinical trial is to establish a new ablative treatment option for lesion-targeted FT in PC.

Background and aim: Superficial musculoaponeurotic system (SMAS) rhytidectomy techniques are widely used in facelift surgery to achieve long-lasting facial rejuvenation. Nonetheless, variations in technique lead to differences in complication rates, aesthetic outcomes, and longevity of results. Current literature lacks a comprehensive network meta-analysis (NMA) that ranks these techniques based on both safety and efficacy. Thus, the aim of this study is to perform a NMA to determine their rankings based on complication and aesthetic outcomes.

Methods and analysis: A network meta-analysis comparing different facelift techniques following PRISMA-NMA guidelines will be conducted. MEDLINE (PubMed), Scopus, Web of Science, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Clinicaltrials.org will be searched from inception to search date. Screening, data extraction, and risk-of-bias assessments will be performed independently by two reviewers and discrepancies resolved by a third independent reviewer. Eligible studies will include randomized controlled trials (RCTs) and observational studies of adult patients undergoing a facelift procedure (SMAS plication, SMASectomy/imbrication, SMAS flap, high lateral SMAS, deep plane facelift, and composite rhytidectomy) and reporting at least one complication outcome (e.g., facial nerve injury, hematoma, seroma, skin necrosis, infection) and/or aesthetic outcome (e.g., patient satisfaction, longevity of results). R 4.4.2 Software (netmeta package) will be used to generate forest plots, treatment rankings, evaluate consistency between direct and indirect evidence, and assess heterogeneity. The ROBINS tool will be used to assess the risk of bias in nonrandomized studies and the RoB 2 tool will be used for RCTs. We will conduct a frequentist fixed- and/or random-effects NMA using the graph theory approach for each outcome. For dichotomous outcomes, odds ratios (ORs) with their corresponding 95% confidence intervals (CIs) will be calculated for all possible pairwise comparisons between the SMAS techniques. For continuous outcomes, standardized mean differences (SMDs) with 95% CIs will be calculated. Sensitivity analyses will be performed in cases of significant heterogeneity. Subgroup analyses by patient characteristics will be performed if sufficient data is available in the included studies.

Background: Large language models (LLMs) are increasingly used in healthcare settings to provide patient education and answer medical inquiries. However, their reliability in delivering accurate, clear, and unbiased information remains uncertain. This study aims to evaluate the quality of responses generated by LLMs to common patient questions regarding facial plastic surgery.

Methods: A total of 60 patient-oriented questions related to facial plastic surgery will be selected from professional bodies, patient support groups, and social media platforms. These questions will be categorized into six main topics: fundamental knowledge, preoperative considerations, surgical procedures, procedural risks and postoperative complications, preparation and recovery, and miscellaneous concerns. Seven LLMs - ChatGPT 4o, Claude, Copilot, DeepSeek, Gemini, Grok, and OpenEvidence - will be tested by inputting each question twice using the "New Chat" feature to assess response consistency. Responses will be evaluated by ten American board-certified plastic surgeons using a structured scoring rubric covering four criteria: accuracy, clarity, completeness, and appropriateness. A standardized scoring system will be employed, and inter-rater reliability will be measured to ensure consistency among evaluators.

Discussion: By systematically assessing the responses of multiple LLMs to patient inquiries on facial plastic surgery, this study will provide insights into their reliability and clinical applicability. Findings may help refine LLM-based tools for patient education and identify areas requiring improvement to ensure safe and effective AI-assisted communication in plastic surgery.

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: Minimally invasive liver surgery (MILS), such as laparoscopic and robotic hepatectomy, has been developed and is an effective alternative to traditional open hepatectomy. Although surgical techniques and postoperative management have improved, many institutions continue to perform routine postoperative abdominal drainage. In open hepatectomy, abdominal drainage after uncomplicated hepatectomy increases overall and wound-related complications without a reduction in the risk of intra-abdominal fluid collections that require intervention. The aim of this study was to elucidate the feasibility of non-routine abdominal drainage for patients who undergo MILS for tumors located outside the posterosuperior area.

Methods and analysis: This study is a multicenter randomized controlled trial and will recruit 182 patients who undergo MILS. The study duration is three years, including a 2-year registration duration. Participants will be randomly assigned to either the non-routine drainage group or the routine drainage group (ratio 1:1) to prove non-inferiority. The primary study outcome is the incidence of in-hospital postoperative complications of Clavien-Dindo grade ≥ II. The secondary study outcomes are length of postoperative hospital stay, incidences of specific postoperative complications and all postoperative complications, and surgery-related mortality.

Ethics and dissemination: Ethical approval has been obtained from the institutional review board (No. 20232008). The results of this study will be published in international peer-reviewed journals.

Background: Stroke is a leading cause of death and disability globally, with significant impairments in upper limb motor function affecting the quality of life of survivors. Despite the potential of transcranial direct current stimulation (tDCS) as a noninvasive neuromodulation technique for enhancing post-stroke recovery, current findings regarding its efficacy and optimal parameters remain heterogeneous and controversial. The purpose of this study is to systematically evaluate the effects of different tDCS parameters on upper limb motor impairments in stroke patients and provide guidance for selecting optimal stimulation parameters via a meta-analysis of available literature.

Methods: A comprehensive literature search (up to 31 December 2024) will be conducted in MEDLINE via PubMed, Cochrane Library, Web of Science, Embase, China National Knowledge Infrastructure (CNKI), and Wanfang Data to gather relevant data on tDCS interventions for post-stroke upper limb impairments. We will use EndNote 21 software for study selection and Stata 16.0 software for data analysis. Studies included will be randomized controlled trials involving adult stroke patients receiving tDCS interventions, with primary outcomes focusing on upper limb motor function scores and secondary outcomes including activities of daily living and adverse events.

Results: This study aims to provide the most up-to-date evidence and recommendations for clinicians and stroke patients to choose an optimal type of tDCS intervention. It will elucidate the impact of different stimulation parameters (e.g., current density, stimulation duration, and target location) on therapeutic outcomes.

Conclusion: tDCS has the potential to positively impact upper limb motor function in stroke patients. This study will provide insights into optimal stimulation parameters, encouraging the integration of tDCS into clinical rehabilitation protocols.

Traumatic injuries remain a leading cause of preventable death globally, and continue to burden global healthcare services, particularly in low-resource settings. Mobile phone-based community injury response and coordination (mCIRC) systems represent a promising solution in facilitating rapid identification of injured persons, and coordinating a community-led response as an alternative or adjunct to a formal emergency service. mCIRC systems may use technologies such as geolocation and push notifications to mobilize trained responders in the vicinity of the incident, ensuring timely intervention before professional medical services arrive. This scoping review aims to provide a comprehensive overview of the existing evidence on the effectiveness and implementation of mCIRC systems in response to trauma as well as other medical emergencies, such as out-of-hospital cardiac arrest. We will evaluate their deployment in both high- and low-resource settings. In particular, the review will assess how these systems improve health outcomes of patients, such as reducing mortality and morbidity, and the feasibility and uptake of such systems by the global community. Additionally, the review will explore the operational challenges and facilitators of implementing such systems, particularly in low- and middle-income countries where healthcare infrastructure is often limited. This review will offer a comprehensive insight into the role of mobile technologies in improving trauma care at the community level, highlighting possible avenues for future research in this domain.

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 and objectives: Musculoskeletal pain is one of the most common conditions in the general population, causing a variety of adverse effects. In addition to pharmacological treatments, the use of acupuncture has increased in recent decades and has shown satisfactory effects. However, the effect of catgut implantation at acupoint (CIA), a specific form of acupuncture, on the treatment of musculoskeletal pain has remained uncertain. Therefore, the aim of this study is to access whether CIA is effective and safe compared with other treatments for musculoskeletal pain.

Methods: Nine electronic databases, including six English databases (e.g. Medline and Embase) and three Chinese databases (e.g. CNKI and Wanfang database) will be searched from the inception to 1 May 2024. Only randomized controlled trials evaluating the effect of CIA for musculoskeletal pain in adults will be included. Two reviewers will independently perform the literature screening, data extraction and quality assessment. Primary outcome is pain symptoms assessed by any pain scale (e.g. visual analogue scale). Pooled results will be calculated using a fixed-effects model if heterogeneity is not significant (I²  < 50%), otherwise, a random-effects model will be used. Several subgroup analyses and sensitivity analyses will be performed. All statistical analyses will be conducted using STATA 18.0.

Results: A synthesis of the current evidence on the effect of CIA on the treatment of musculoskeletal pain will be published in a peer-reviewed journal.

Conclusions: This study will provide high quality evidence of the effect of CIA on the treatment of musculoskeletal pain.