International Journal of Surgery Protocols最新文献

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.

Background: Prostate cancer is the second most commonly diagnosed cancer in men worldwide. Prostate biopsies are essential for diagnosis but often induce significant pain and anxiety despite local anesthesia. Virtual reality (VR) has emerged as a promising non-pharmacological tool for pain management during medical procedures. This study aims to assess the effect of virtual reality hypnosis (VRH) as an adjunct to standard local anesthesia during prostate biopsies.

Methods: This single-center, prospective, randomized, controlled, parallel-group, single-blind trial will compare standard prostate biopsies under local anesthesia with and without VRH. A total of 130 patients will be randomized in a 1:1 ratio to receive either standard care with local anesthesia alone or standard care plus VRH. The VRH will be initiated 15 minutes pre-procedure and continue throughout. The primary outcome is the maximum pain assessed using a 0-10 Numerical Pain Rating Scale immediately post-procedure by a blinded assessor. Secondary outcomes include post-procedure pain, anxiety, physiological stress response, immersion level, patient satisfaction, procedural success, additional analgesia needs, procedure duration, and adverse events. Follow-up will occur at 1 month.

Discussion: This trial will provide high-quality evidence regarding VRH effectiveness as a non-pharmacological adjunct for pain management during prostate biopsies. By targeting both anticipatory anxiety and procedural pain, this approach may significantly improve patient comfort. If effective, this technique could transform the standard of care for prostate biopsies and potentially extend to other invasive urological procedures.

Introduction: Follow-up data in breast cancer is essential and forms the basis for survival metrics and key statistical measures related to morbidity and mortality. Standard practice classifies any woman who does not engage in reviews/follow-up as "lost to follow-up (LTFU)," effectively excluding her from further analysis and disregarding her data. This study aims to evaluate patterns and predictors of LTFU among women with non-metastatic breast cancer.

Design: This is a single-center prospective cohort study involving women diagnosed with non-metastatic breast cancer between 2017 and 2018. The study will follow a three-phase approach. In Phase I, 5-year follow-up data will be collected retrospectively through hospital records and electronic medical records (EMRs) up to 2024. In Phase II, patients identified as LTFU will be contacted using phone, SMS, or email to assess health status and update follow-up data. Informed consent will be obtained during outreach. In Phase III, patients who respond will be asked about reasons for missed follow-up visits, including barriers related to logistics, finance, awareness, or physician advice. Data will be analyzed using descriptive statistics, logistic regression, and thematic analysis.

Objectives: To determine the proportion of patients who are lost-to-follow-up at 5 years, identify factors associated with LTFU, and explore patient-reported barriers to follow-up in a public sector cancer care setting.

Discussion: This study uses a mixed-methods approach, combining quantitative tracking with qualitative insights, with the aim of understanding patient retention and long-term oncology care. This study will provide real-world evidence on follow-up adherence and its determinants in a high-volume, resource-constrained oncology setting. The study is registered with ClinicalTrials.gov (Trial identifier: NCT06927102).

Background: Capsular contracture remains a significant complication in implant-based breast reconstruction, particularly in the context of prepectoral direct-to-implant (DTI) techniques. The advent of acellular dermal matrices (ADMs) has enabled broader adoption of prepectoral reconstruction by enhancing implant support and tissue integration. FlexHD Pliable PRE is a novel ADM designed specifically for prepectoral breast reconstruction, featuring fenestrations and conformable architecture to optimize pocket support and aesthetic outcomes. However, clinical data evaluating capsular contracture rates and associated risk factors with this product remain limited.

Objective: To determine the incidence of capsular contracture and identify associated risk factors in patients undergoing prepectoral DTI breast reconstruction using FlexHD Pliable PRE.

Methods: This retrospective cohort study includes all consecutive patients who underwent prepectoral DTI breast reconstruction with FlexHD Pliable PRE between February 2017 and June 2024. Exclusion criteria include subpectoral placement, autologous reconstruction, and follow-up under 12 months. Patient demographics, procedural details, and postoperative outcomes (including capsular contracture, implant malposition, infection, implant loss, and other potential complications) will be collected. Capsular contracture will be defined as Baker grade III/IV. Univariate analysis and multivariable logistic regression will identify independent predictors of contracture.

Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) remains the diagnostic benchmark for mediastinal staging, though geriatric patients require optimized anesthesia due to compromised pharmacokinetics and elevated perioperative risks.

Methods: A prospective, double-blinded, randomized controlled clinical trial is conducted at a tertiary hospital. Sixty eligible patients aged over 70 years who underwent EBUS-TBNA under general anesthesia were enrolled. Participants were randomized 1:1 to receive either propofol (Group P, n = 30) or remimazolam besylate (Group R, n = 30) with protocolized perioperative management. Primary outcome assessed anesthesia emergence quality. Secondary outcomes encompassed serial hemodynamics, cumulative vasoactive drug requirements, recovery metrics (time/quality), 24-hour QoR-40 scores, and perioperative complications.

Discussion: This randomized trial compared remimazolam and propofol for EBUS-TBNA anesthesia in elderly patients. Remimazolam demonstrated accelerated Steward recovery and enhanced hemodynamic stability, whereas propofol exhibited risks of adipose tissue deposition and hypotension. These pharmacodynamic profiles inform anesthetic optimization in geriatric cohorts, necessitating multicenter validation of age-adjusted protocols.

Background: Thoracic trauma significantly contributes to Iraq's trauma mortality. While the Thoracic Trauma Severity Score (TTSS) and the Trauma and Injury Severity Score (TRISS) are validated internationally, their effectiveness in low-resource settings like Iraq remains unclear. This study aims to address this critical gap by evaluating and comparing the predictive performance of both tools in predicting clinical outcomes. The findings of this study will lay the groundwork for developing a more suitable chest trauma scoring model tailored to this unique setting and similar environments with limited resources.

Methods: Prospective cohort study that will recruit 195 adult chest trauma patients (blunt/penetrating) from March to December 2025. Based on standardized protocols, TTSS and TRISS scores will be calculated within 6 hours of admission. Primary outcome: in-hospital mortality. Secondary outcomes: intensive care unit (ICU) admission, morbidity, early hospital discharge, and surgical intervention. Predictive accuracy will be compared using ROC-AUC analysis and sensitivity/specificity.

Discussion: TTSS is likely to demonstrate greater specificity for thoracic outcomes than TRISS. Possible limitations include resource-related constraints that lead to inappropriate ICU allocation and prehospital delays affecting physiological measures. If validated, TTSS may streamline emergency room triage across Iraq-utilizing scarce critical care resources more effectively. Further studies should be done to validate findings across the various trauma centers in Iraq and develop hybrid scoring models.

Background: Direct-to-implant (DTI) breast reconstruction has become a widely accepted approach for postmastectomy breast reconstruction. Traditionally, implants were placed in the subpectoral (SP) plane to maximize soft tissue coverage; however, recent advances in surgical technique and implant materials, such as acellular dermal matrices (ADMs) and meshes, have led to a resurgence in the prepectoral (PP) approach. Recent studies have shown conflicting evidence regarding their respective complication profiles and patient-reported outcomes. Thus, comprehensive head-to-head meta-analysis is needed to evaluate the safety and effectiveness of PP versus SP in DTI breast reconstruction.

Methods: Following PRISMA guidelines, this systematic review and meta-analysis will compare complication rates and patient-reported outcomes between PP and SP in DTI reconstruction. MEDLINE (PubMed), Scopus, Web of Science, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Clinicaltrials.org will be searched to identify comparative studies. Eligible studies must report at least one primary outcome, such as capsular contracture or surgical complications. Secondary outcomes will include BREAST-Q scores, pain scores, and length of hospital stay. Data will be extracted independently by two reviewers, and methodological quality will be assessed using appropriate risk of bias tools (ROBINS-I for nonrandomized studies and Rob 2 for randomized controlled trials). Meta-analysis will be performed using Review Manager 5.4, applying random-effects models in cases of significant heterogeneity. Subgroup and sensitivity analyses will be conducted where applicable.

Discussion: This study aims to synthesize the current evidence comparing PP and SP in DTI breast reconstruction to inform surgical decision-making and optimize patient outcomes. The results will provide surgeons and patients with a clearer understanding of the benefits and risks associated with each reconstructive plane.

Background: Postoperative pain management remains a critical determinant of functional recovery following total knee arthroplasty (TKA). While local infiltration analgesia (LIA) is commonly employed, its clinical utility is limited by inconsistent analgesic duration (median duration of 8-12 hours), technical variability among surgeons, and systemic toxicity risks associated with high-volume injections. This phase II randomized controlled trial evaluates a dual-optimization strategy combining anatomic mapping-guided periarticular cutaneous nerve (PCN) blockade with a sustained-release triamcinolone-ropivacaine formulation to address these limitations.

Method: In this single-center, assessor-blinded, 2 × 2 factorial design, 120 adults undergoing primary unilateral TKA were randomized to four intervention arms: Group 1: Conventional iPACK (interspace between the popliteal artery and posterior knee capsule) site + novel formulation (1% ropivacaine + 40 mg triamcinolone); Group 2: PCN block site + standard formulation (1% ropivacaine + 5 mg dexamethasone); Group 3: PCN block + novel formulation; Group 4: Control (iPACK + standard formulation). Triamcinolone acetonide replaces dexamethasone in the new formulation due to its prolonged anti-inflammatory effect and demonstrated efficacy in periarticular analgesia. Primary endpoints included: resting/movement-induced pain intensity (Visual Analog Scale) at 6, 24, and 48 h postoperatively, cumulative opioid consumption (morphine milligram equivalents), functional recovery metrics (knee flexion angle, Timed Up-and-Go test). Secondary outcomes assessed safety through adverse event rates (infection, neurologic symptoms, hemodynamic instability).

Conclusions: Anatomic mapping-guided PCN blockade combined with triamcinolone-ropivacaine formulation significantly improves postoperative analgesia and functional outcomes compared to conventional LIA techniques. This dual-optimization approach may redefine periarticular infiltration standards in TKA, particularly for patients at high risk of opioid-related complications.

Prostate cancer is one of the most prevalent malignancies among men, with early and accurate diagnosis is essential for optimizing clinical outcomes. The Trinetra-Prostate^TM 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.