This review aimed to systematically synthesize and standardize evaluation parameters for preclinical studies of absorbable meshes in abdominal wall hernia repair models. A comprehensive database search was conducted to identify comparative studies on the remodeling and regenerative properties of absorbable meshes in animal models of abdominal wall hernia. Stratified analysis of dimensional indicators was performed across species, and study characteristics, epidemiological data, and key model attributes were visually summarized and analyzed. Remodeling and regenerative properties were assessed across seven major dimensions: inflammatory response, scaffold degradation, tissue integration, neovascularization, extracellular matrix (ECM) deposition, cellular infiltration, and fibrotic encapsulation. Evaluation methods encompassed histological analysis, molecular assays, general observation, and biomechanical testing, with outcomes reported in qualitative, quantitative, or combined formats. Inflammatory response, scaffold degradation, tissue integration, and neovascularization emerged as the most frequently assessed metrics. Histological assessment was the predominant evaluation method, and qualitative data presentation was most common. Species-stratified analysis revealed that rats and rabbits were the most frequently used models. Rat studies primarily focused on ECM deposition, inflammation, and tissue integration, whereas rabbit studies emphasized ECM deposition and inflammatory response. Inflammatory response, scaffold degradation, tissue integration, neovascularization and ECM deposition constitute core dimensions for evaluating tissue remodeling and regeneration. However, current studies show substantial inconsistency in endpoint selection and dimensional emphasis, with limited diversity in measurement techniques and a lack of consensus across species-specific models. Future research should establish species-specific core outcome sets and adopt multidimensional strategies to enable comprehensive evaluation of absorbable mesh performance.
PURPOSE: To comprehensively analyze the epidemiological characteristics of research protocols on international animal experiment registration platforms, explore potential factors influencing protocol publication, and offer recommendations to improve animal experiment registration systems. METHODS: Research protocols registered on the Netherlands’ PCT(Preclinical Trials) and Germany’s ASR(Animal Study Registry) animal experiment registration platforms up to December 30, 2024, were included. Relevant data were extracted, and frequency distributions and percentages were calculated to statistically describe the findings. Factors influencing publication rates were identified using chi-square tests and multivariate binary logistic regression analysis. RESULTS: A total of 272 registered protocols were analyzed, including 124 from the PCT platform and 148 from the ASR platform, originating from 31 countries, spanning 47 research areas, and involving 11 different animal species. Among the studies, 10.0% (27/272) did not report randomization, and none of the randomized studies (132/272) addressed allocation concealment. Additionally, 24.6% (67/272) and 35.3% (96/272) failed to report blinding during intervention implementation and outcome measurement, respectively. Only 43.3% (97/224) of the experiments were completed within the specified timeframe, and among these, merely 23.7% (23/97) achieved full publication. Animal species were identified as potential influencing factors. Studies using pigs as animal models were more frequently published. CONCLUSION: As a vital measure to enhance the quality of animal experiments, the registration of animal protocols requires joint emphasis and coordinated promotion by multiple stakeholders, including researchers, research institutions, ethics committees, journal editors, funding agencies, and regulatory authorities. Strengthening protocol registration will not only improve transparency, reproducibility, and ethical oversight, but also build a more trustworthy foundation for high-quality evidence and accelerate the clinical translation of animal research.
ObjectiveTo systematically map the landscape of animal studies on absorbable meshes for hernia repair published from 2003 to 2025, with a focus on material types, animal models, follow-up durations, and outcome measures, and to access their implications for clinical translation.MethodsStudies published between 2003 and 2025 involving animal models of hernia repair were systematically identified and screened. Data on material classification, animal species, follow-up duration, and outcome domains were extracted and synthesized using an evidence mapping framework.ResultsA total of 165 studies covering 183 mesh types were included. Self-fabricated meshes were more commonly used than commercial products (62.3% vs 37.7%), with biologically derived materials predominating. Rats and rabbits were the primary experimental models, while follow-up durations were generally short, limiting long-term performance assessment. Although large-animal studies remained limited, their use-particularly miniature pigs and nonhuman primates-has increased in recent years due to greater physiological relevance. Histological outcomes and postoperative complications were most frequently reported, whereas long-term functional outcomes were rarely assessed. Substantial heterogeneity in scoring systems and evaluation methods was observed across studies.ConclusionPreclinical research on hernia repair materials is largely dominated by short-term, small-animal experiments using self-fabricated biologically derived meshes. Greater emphasis on large-animal models, extended follow-up, and standardized, multi-level outcome frameworks is needed to strengthen translational relevance.
Evidence-based medicine (EBM), formalized in the 1990s, has redefined clinical practice by advocating the integration of research evidence, clinical expertise, and patient values. This paradigm has introduced methodological rigor through randomized controlled trials (RCTs) to establish causality, systematic reviews to synthesize findings, and the GRADE approach to evaluate evidence based on risk of bias, inconsistency, indirectness, imprecision, and publication bias. These advancements have shaped clinical guidelines, reduced practice variability, and influenced medical education toward evidence-based inquiry. Despite its contributions, EBM faces challenges in the evolving landscape of modern medicine. The lengthy process of evidence generation, often requiring years for trials and guideline updates, limits responsiveness to emerging health needs, as observed during the COVID-19 pandemic. The external validity of RCT results is constrained by strict inclusion criteria, posing difficulties in applying findings to diverse patient populations with comorbidities. Additionally, the siloed nature of evidence complicates comprehensive care for multifactorial conditions, while the annual influx of over one million medical publications overwhelms traditional synthesis methods. Artificial intelligence (AI) presents a promising avenue to address these issues, leveraging capabilities in processing heterogeneous data. Natural language processing may enhance literature analysis, machine learning could identify patterns in complex datasets, and causal inference might improve the reliability of observational data insights. These technologies hold potential to accelerate evidence development and tailor it to individual needs. This paper proposes digital intelligent evidence-based medicine (i-EBM) as a conceptual evolution of EBM, designed for the AI era. i-EBM envisions a three-layered framework. The data foundation layer aims to integrate structured evidence from RCTs, domain knowledge such as biomedical ontologies and traditional Chinese medicine principles, and multi- modal patient data, including electronic health records, genomics, and wearable device outputs. Knowledge graphs are proposed to link these elements into a unified, computable knowledge network. The intelligent processing layer seeks to apply AI for evidence retrieval, data extraction, quality assessment, and synthesis, potentially using large language models to assist these processes. The knowledge service layer intends to provide dynamic guidelines and individualized predictions, supported by ongoing human-machine collaboration to ensure clinical relevance and ethical considerations. i-EBM has the potential to mitigate EBM's limitations by facilitating real-time evidence updates, reducing knowledge fragmentation through integrated data, and offering personalized decision support. For instance, it may support precision medicine by connecting diverse data sources, with applications possibly extending to fields like oncology or traditional Chinese medicine. Future research could explore autonomous AI systems, optimized clinical workflows, and governance frameworks to address data privacy, bias, and global standardization. In conclusion, i-EBM offers a theoretical framework to extend EBM principles, harnessing AI's potential alongside human expertise to advance medical research and practice. Meanwhile, for issues such as the quantitative study of the complex intervention characteristics and syndrome differentiation patterns of traditional Chinese medicine, i-EBM can provide methodological support in data integration, pattern recognition, and causal inference, offering potential tools and insights for uncovering the intrinsic regularities of TCM evidence and optimizing its evaluative framework.
Gastric signet-ring cell carcinoma (GSRCC) represents 10%-14% of all gastric malignancies. The overall prognosis for GSRCC is poorer compared to other types of gastric cancer, as it is characterized by a high degree of malignancy, rapid progression, and early metastasis (particularly peritoneal metastasis). Current therapies combining surgery and chemotherapy are challenged by tumor invasiveness, drug resistance, and limited targeted options. Herein, we present the case of a 60-year-old male diagnosed with GSRCC who underwent laparoscopic distal radical gastrectomy with D2 lymphadenectomy. Postoperative histopathological analysis confirmed a mixed tumor composition comprising 60% GSRCC and 40% moderately differentiated adenocarcinoma. Following surgery, the patient was administered adjuvant therapy with oxaliplatin and S-1 and metformin enteric-coated tablets for 6 months, followed by 42-month maintenance therapy regimen combining oral S-1 and apatinib and metformin enteric-coated tablets. Over 9 years of follow-up, the patient demonstrated sustained recurrence-free survival (RFS) and achieved clinical recovery. This case underscores the potential of individualized adjuvant therapy in addressing the aggressive biological characteristics of GSRCC and offers a valuable reference for strategies to minimize recurrence in GSRCC patients. Trial Registration: ClinicalTrials.gov identifier NCT01101438.
BackgroundTo investigate the endorsement of the 32-item Consolidated Criteria for Reporting Qualitative (COREQ) and Standards for Reporting Qualitative Research (SRQR) in the instructions for authors (IFA) of Chinese nursing journals. The awareness of Chinese editors of the COREQ and SRQR, together with their application and requirements for following the standards, were also investigated. These findings would assist as the endorsement, application, and promotion of the COREQ and SRQR in Chinese nursing journals, and improve the reporting quality of qualitative research in nursing.MethodsNursing journals were identified from the National Press and Publication Administration. The IFA and applications of the COREQ and SRQR were assessed. The editors of the journals were asked about their awareness of and demand for the COREQ checklist and SRQR standards, as well as their implementation at different stages of the publication process, including manuscript submission, editing, and peer review.ResultsA total of 29 nursing journals were included, and only 2 journals (6.9%, 2/29) mentioned the COREQ and SRQR in their IFA. Among the 24 surveyed editors, only 45.83% (11/24) and 33.33% (8/24) were aware of the COREQ and SRQR, respectively. None of the surveyed editors required authors to follow the COREQ/SRQR at the submission stage, editors to follow COREQ/SRQR in the journal editing and processing stage, and reviewers to use the COREQ/SRQR in the expert review stage.ConclusionNursing journals in China endorsing the COREQ and SRQR constitute a small percentage of the total. In addition, both awareness and application of the COREQ and SRQR were poor among nursing journal editors. Therefore, we strongly recommend that the China Periodicals Association undertake measures to encourage and support the endorsement of biomedical research reporting guidelines in nursing journals. Also, the education and training of journal editors, researchers, and medical students on biomedical research reporting guidelines should be strengthened.
Background Current evidence on the relationship between periodontitis and hypertension remains inconsistent. We performed a two-sample univariable and multivariable Mendelian randomization (MR) study to investigate the causal relationships between periodontitis and elevated blood pressure as well as hypertension. Methods We selected single nucleotide polymorphisms (SNPs) with strong (P < 5×10-8) or moderate (P < 5×10-6) evidence of association with periodontitis from genome-wide association studies. Summary-level genetic data for elevated blood pressure and hypertension were obtained from the International Consortium of Blood Pressure Genome-Wide Association Studies and the UK Biobank. Primary analyses used SNPs strongly associated with periodontitis, whereas secondary analyses extended this set to include SNPs with moderate association. Fixed- and random-effects inverse variance weighted (IVW) methods were employed to assess the causal associations, and multivariable MR was performed to verify the robustness of results. MR estimates were calculated as coefficients (β) with 95% confidence intervals (CIs) for continuous blood pressure outcomes, and as odds ratios (ORs) with 95% CIs for the binary hypertension outcome. Results In primary analyses, genetic liability to periodontitis showed a nominally significant association with a 0.105mmHg increase in systolic blood pressure (95% CI: 0.009, 0.200; P = 0.032), which indicated a potential association but does not reach the Bonferroni-corrected significance threshold (P < 0.008). No robust causal associations were observed for diastolic blood pressure (β = 0.049, 95% CI: –0.006, 0.104; P = 0.083) or pulse pressure (β = 0.058, 95% CI: –0.007, 0.123; P = 0.079). Secondary analyses incorporating both strongly and moderately associated SNPs yielded no evidence supporting a causal effect of genetic liability to periodontitis on elevated blood pressure risk. In addition, a genetic liability to periodontitis was not associated with increased risk of hypertension (including essential hypertension, secondary hypertension, and total hypertension) in both primary and secondary analyses. These null associations for elevated blood pressure and hypertension remained after adjustment for smoking, alcohol consumption and body mass index separately or together in the multivariable MR analysis. Conclusions The results suggested that genetic liability to periodontitis was not significantly associated with the risk of elevated blood pressure and hypertension after multiple testing corrections. Large-scale prospective observations and multi-omics studies are warranted to further clarify the associations between periodontitis and blood pressure-related disorders.
[This corrects the article DOI: 10.3389/fimmu.2025.1705852.].
Tissue-inducing biomaterials, which promote tissue regeneration without the addition of exogenous cells and/or bioactive factors, have recently attracted increasing interest in the repair of nonosseous tissues. As a key strategy for transforming data into actionable evidence, evidence-based biomaterials research plays a critical role in guiding material development. In this study, evidence mapping method was employed to systematically analyze and visualize animal study designs, material characteristics, outcome indicators, and evaluation methods, aiming to identify current research trends and emerging focal areas. The results revealed a wide diversity of experimental animal species, with a predominance of small animal models. Among the 19 types of nonosseous tissues investigated, skin, abdominal wall, cartilage, and blood vessels were the most frequently studied. Materials were mainly classified into bio-derived materials, polymers, and composites. Outcome indicators span from macroscopic to molecular levels, with tissue-level indicators being the most commonly applied. Histological analysis served as the primary method for validating inductive effects, supported by gross observation, imaging analysis, molecular biology assays, and biomechanical testing. Overall, tissue-inducing biomaterials show promising potential for nonosseous tissue regeneration. However, challenges remain, including limitations of animal models, short follow-up periods, and insufficient evaluation systems. Future studies should strengthen the alignment between functional validation and clinical needs to promote the translation of these materials from experimental research to clinical application.
Evidence is a core element of evidence-based medicine, with diverse classifications and extensive sources. Most of it is based on journals and is commonly found in databases or websites such as PubMed, Web of Science, and CNKI. The number of literatures is countless, which also puts enormous pressure on researchers to consult and read literature. The field of urology is no exception. This article started with analyzing the characteristics of common clinical questions in the field, introduced the four criteria for their screening and two types of structured templates, clarified the definition, categories, identification, and three requirements for the application of the four evidence classification methods, and explained the selection of retrieval resources, construction of retrieval strategies, specific operational steps, and precautions for the retrieval process to develop and use evidence. In addition, combined with artificial intelligence technology, the future development trend of evidence classification and retrieval in the field of evidence-based urology has been clarified, which provided reference for further promoting the development of evidence-based urology.
Gastric cancer, a leading global cause of cancer-related mortality, is frequently diagnosed at advanced stages with peritoneal metastasis, significantly limiting curative options. Current strategies integrate systemic chemotherapy, hyperthermic intraperitoneal chemotherapy (HIPEC), and targeted therapies, yet outcomes remain suboptimal. Claudin18.2, a tight junction protein overexpressed in 27.4–52% of gastric cancers, has emerged as a novel therapeutic target, with recent Phase III trials demonstrating survival benefits for Claudin18.2-targeted monoclonal antibodies in HER2-negative advanced disease. However, the synergy of HIPEC with Claudin18.2-targeted therapies remains unexplored. This study presents a case of Claudin18.2-positive advanced gastric adenocarcinoma with peritoneal metastasis treated with a multimodal regimen: HIPEC, systemic CapeOx chemotherapy, and Claudin18.2-targeted therapy (ASKB589). Following 12 cycles, imaging and tumor markers (CA125, CEA) normalized, enabling curative gastrectomy. At 893 days post-diagnosis, the patient remains disease-free (PFS/DFS: 893/573 days) on adjuvant capecitabine. Treatment-related toxicities (predominantly Grade 1–3 hematologic and gastrointestinal events) were manageable. This case highlights Claudin18.2 as an actionable biomarker and proposes a “local-systemic” synergy model for peritoneal-metastatic gastric cancer. However, the absence of cytoreductive surgery and single-case limitations necessitate validation through randomized trials. Future research should prioritize biomarker-driven HIPEC protocols (e.g., nanoparticle-enhanced Claudin18.2-targeted delivery) and dynamic monitoring of Claudin18.2 expression during therapy.
OBJECTIVES:Rotator cuff injuries are a leading cause of shoulder dysfunction, where bio-inductive collagen implants have demonstrated promising results in promoting tendon regeneration and reducing retear rates. However, existing evidence lacks consistent evaluation across varying follow-up durations, while the specific factors influencing their safety and effectiveness remain undetermined. This study aims to evaluate the quality of evidence regarding the safety, efficacy, and impact factors of applying the resorbable bio-inductive collagen implant clinically to repair rotator cuff injuries. METHODS:The study protocol was registered on PROSPERO (CRD42022367522). A systematic literature search of PubMed, Web of Science, Embase, and Cochrane Library (from inception to October 2024) for clinical studies on bio-inductive collagen implants for rotator cuff repair. Two investigators independently screened studies, extracted data, and assessed quality (using RoB1 for RCTs, NOS for cohort studies and JBI critical appraisal tools for case series). Primary outcomes included postoperative tendon thickness, shoulder function scores (ASES/Constant), and re-tear rates. Data were analyzed using random/fixed-effects models to calculate mean differences (MDs) with 95% CIs, with subgroup analyses for tear type, patient age, and postoperative mobilization time. Statistical analyses were performed using Stata 17.0. RESULTS:Seventeen studies were included. The meta-analysis results showed that postoperative tendon thickness of the patients increased statistically compared with the baseline, at 3 months (MD = 2.22; 95% CI: 1.61, 2.83; p < 0.001), 6 months (MD = 2.30; 95% CI: 1.44, 3.16; p < 0.001), 12 months (MD = 2.15; 95% CI: 1.58, 2.72; p < 0.001), and 24 months (MD = 1.05; 95% CI: 0.02, 2.08; p = 0.045). Postoperative shoulder joint function improved significantly. The ASES score and Constant score of the patients were significantly higher than the baseline at 6 months (ASES: MD = 35.90; 95% CI: 32.97, 38.83; p < 0.001), 12 months (ASES: MD = 40.83; 95% CI: 37.56, 44.10; p < 0.001; Constant: MD = 28.59; 95% CI: 21.44, 35.74; p < 0.001), and 24 months (ASES: MD = 39.80; 95% CI: 31.32, 48.27; p < 0.001; Constant: MD = 32.84; 95% CI: 28.72, 36.97; p < 0.001). CONCLUSION:The bio-inductive collagen implant is effective and safe for healing rotator cuff injuries. Patient age may be an important moderator affecting its efficacy. The impact of tear size and postoperative activities on efficacy needs to be further explored through in-depth clinical studies.
ObjectiveIdentify factors associated with the engraftment of gastric cancer patient-derived xenograft (GC PDX) in the renal capsule and explore optimal MRI sequence parameters for observing renal capsule PDX.MethodsTumor tissues from 33 gastric cancer patients were cut into fragments of 1×1×1 mm, 2×2×2 mm, and 3×3×3 mm, then transplanted beneath the renal capsule of NOD/SCID mice within 2, 8 and 24 hours. Depending on tissue availability, tumor samples from each patient were implanted into 1–4 mice, totaling 73 mice. Clinical data were collected. Tumor growth was monitored weekly via MRI. T1WI, contrast-enhanced T1WI, T2WI was used to measure tumor length. After euthanasia (10g/L sodium pentobarbital, 180mg/kg, intraperitoneal), tumors were excised, and caliper-measured were compared with MRI results. The xenografts were serially passage into new mice for three generations. Histopathological (H&E), Ki67 immunohistochemistry were performed to assess similarity with primary tumors.ResultsTumors from 20 out of 33 patients successfully engrafted in 28 out of 73 mice. The 2×2×2 mm grafts and transplantation in 2 hours had a higher success rate. Patient serum albumin was associated with successful engraftment. PDX exhibited isointense and hyperintense on T2WI and marked enhancement on T1WI post-contrast. No significant difference was observed between MRI and caliper-measured. H&E staining, Ki67 expression confirmed that PDX tumors retained histological features of primary tumors.ConclusionOptimal conditions for establishing GC PDX models involve transplanting 2×2×2 mm tumor fragments within 2 hours. MRI enables sensitive tumor detection and accurate size quantification. T2WI was the most effective and efficient imaging technique. Providing an efficient preclinical model for personalized therapy of gastric cancer.
This study compared the feasibility, efficacy, and safety of robotic splenectomy with pericardial devascularisation (TRSPD) versus total laparoscopic splenectomy with pericardial devascularisation (TLSPD) in patients with portal hypertension (PHT) complicated by splenomegaly, hypersplenism, and oesophagogastric varices. A retrospective cohort analysis was conducted on 17 patients undergoing minimally invasive splenectomy with pericardial devascularisation between 2022 and 2024. Outcomes included operative metrics, postoperative recovery, and portal hypertension resolution. TRSPD significantly reduced intraoperative blood loss (175 vs. 436 mL, p = 0.004) despite longer operative duration (400 vs. 256 min, p = 0.001). Zero conversions occurred with TRSPD versus 3 conversions with TLSPD (p = 0.02). Postoperatively, TRSPD accelerated gastrointestinal recovery (2.1 vs. 3.5 days, p = 0.02) and shortened drainage duration (4.0 vs. 6.2 days, p = 0.02). Both techniques normalised haematologic indices, reduced portal vein diameter (p < 0.05), and resolved varices without major complications. TRSPD demonstrates superior intraoperative safety and faster recovery compared with TLSPD while achieving equivalent therapeutic efficacy for portal hypertension. Robotic approaches may optimise the minimally invasive management of complex portosplenic vascular pathologies.
This review investigates the variability in the experimental methodology used in animal studies exploring the optimal composite mesh for incisional hernia (IH) repair. Eight databases were searched from inception to April 1, 2023. Animal studies conducted to evaluate the anti-adhesion effect of the composite mesh were included. Standardized forms were used to extract the experimental design characteristics. The extracted data were presented in tabular format and summarized using frequency analysis. The inherent risk of bias in the included studies was assessed using SYRCLE's risk of bias tool for animal studies. The results showed that 71 studies were included in the final analysis. Rats represented the most common animal (65%) used for studies. Conventional models (92%), high-adhesion models (4%), and abdominal cavity pollution models (4%) were reported in the included studies. The sample size of animals varied between studies (2-31/group). A variety of quantitative (calculation of adhesion area or testing of adhesion strength) and qualitative (45 assessment systems) adhesion assessment methods were reported. One month (41%) and 1 week (30%) were the most common time points used to evaluate the adhesion. The results of the risk of bias assessment showed that, of the 71 animal studies included, only one was a randomized controlled study, and only two studies reported that animal breeders and investigators were blinded. In conclusion, a large number of animal studies have been conducted to explore the ideal intraperitoneal anti-adhesive composite mesh for IH repair. However, these animal studies have significant differences in animal models, implantation procedures, control selection, and adhesion assessment. These differences directly affect the comparability between studies and the reproducibility of the studies.
Poor ovarian response (POR) significantly impacts the success of assisted reproductive technology (ART), and growth hormone (GH) has been proposed as an adjuvant treatment to improve outcomes in POR patients undergoing in vitro fertilization (IVF). A systematic review and meta-analysis were conducted to evaluate the effectiveness of GH in enhancing pregnancy outcomes, registering a protocol on PROSPERO and searching multiple databases up to September 2023. Twelve systematic reviews/meta-analysis and 20 randomized controlled trials (RCTs) involving 1984 patients were included. Quality assessment was performed using AMSTAR 2, GRADE, and RoB tools. The meta-analysis revealed that GH significantly increased live birth rates [OR=1.80, 95
Animal models are essential for advancing clinical research on abdominal wall hernias. However, existing preclinical studies often have inconsistencies and limitations, hindering the translation of findings into clinical practice. This systematic review evaluates preclinical animal studies to summarize methodologies used in abdominal wall hernia research, aiming to standardize animal model development and improve the clinical relevance of research outcomes. A systematic search was conducted across databases like PubMed, Embase, Web of Science, CNKI, Wanfang, CQVIP, and CBM, focusing on preclinical animal studies using mesh interventions for abdominal wall hernias. The SYRCLE tool was used to assess the methodological quality and risk of bias in the included studies. Key study characteristics, including animal details (species, sex, weight, etc.) and modeling specifics (hernia type, defect size, repair method, etc.), were extracted and analyzed. The review included 246 medium-quality studies involving 9,098 animals from eight species. Rats (54.1
Postoperative nausea and vomiting (PONV) is a common postoperative complication that substantially influences patient recovery and healthcare quality. To further standardize PONV management in China, the Chinese Society of Anesthesiology, in collaboration with multidisciplinary experts, has developed the Clinical Practice Guidelines on Postoperative Nausea and Vomiting Management (2025 Edition) using evidence-based methodologies. This guideline addresses 21 clinical issues on PONV management and proposes 35 evidence-based recommendations covering risk-factor identification, selection of assessment tools, optimization of anesthesia techniques, and multimodal intervention strategies. Evidence quality is graded into four levels (high, moderate, low, and very low) using the GRADE system, with recommendation strength clearly indicated (strong/weak recommendations or good practice statements). The guidelines aim to establish China-specific standardized protocols to provide evidence-based guidance for anesthesiologists and healthcare professionals, supporting Enhanced Recovery After Surgery (ERAS) implementation.
BackgroundTotally implantable venous access ports (TIVAPs) are essential for chemotherapy delivery but carry complication risks potentially mitigated by standardized procedures. This study assessed the safety and efficacy of ultrasound-guided internal jugular vein (IJV) TIVAP implantation under a standardized protocol in cancer patients, with a specific focus on characterizing complications and identifying risk factors.MethodsA retrospective analysis included 175 cancer patients who underwent right IJV TIVAP implantation (B. Braun Celsite ST305P, 6.5 F) between September 2020 and March 2024. Standardized procedures mandated ultrasound-guided puncture, intraoperative fluoroscopic tip positioning (target: cavoatrial junction), and postoperative chest X-ray. Procedural success, operative time, patient demographics, comorbidities, and complications (early: ≤30 days; late: >30 days) were recorded. Multivariable Cox regression identified complication risk factors.Resultsprocedural success was 100% (175/175). The mean operative time was 40 ± 12 minutes. Crucially, no early complications (0/175) occurred. Late complications developed in 14 patients (8.0%, incidence: 0.05/1000 catheter days). All late complications were skin ulcers around the port/catheter with device exposure. Multivariable analysis revealed that concurrent diabetes mellitus and hypertension (DM + HTN) was the only significant independent predictor of complications (Hazard Ratio (HR) = 12.223, 95% Confidence Interval (CI): 1.168-127.929, P = 0.037) compared to patients without these comorbidities. Age, sex, tumor type, and BMI were not significant risk factors.ConclusionsUltrasound-guided IJV TIVAP implantation under the described standardized protocol is safe (no early complications) and effective (100% success). The predominant late complication was skin ulceration. The concurrent presence of diabetes and hypertension represents a strong independent risk factor for TIVAP-related complications, emphasizing the critical need for comprehensive preoperative risk assessment and optimization of metabolic health in these patients.