Introduction Up to one-fifth of breast cancer survivors will develop chronic breast cancer-related lymphoedema (BCRL). To date, complex physical decongestion therapy (CDT) is the gold standard of treatment. However, it is mainly symptomatic and often ineffective in preventing BCRL progression. Lymphovenous anastomosis (LVA) and vascularised lymph node transfer (VLNT) are microsurgical techniques that aim to restore lymphatic drainage. This international randomised trial aims to evaluate advantages of microsurgical interventions plus CDT versus CDT alone for BCRL treatment. Methods and analysis The effectiveness of LVA and/or VLNT in combination with CDT, which may be combined with liposuction, versus CDT alone will be evaluated in routine practice across the globe. Patients with BCRL will be randomly allocated to either surgical or conservative therapy. The primary end point of this trial is the patient-reported quality of life (QoL) outcome ‘lymphoedema-specific QoL’, which will be assessed 15 months after randomisation. Secondary end points are further patient-reported outcomes (PROs), arm volume measurements, economic evaluations and imaging at different time points. A long-term follow-up will be conducted up to 10 years after randomisation. A total of 280 patients will be recruited in over 20 sites worldwide. Ethics and dissemination This study will be conducted in compliance with the Declaration of Helsinki and the International Council for Harmonisation-Good Clinical Practice (ICH-GCP) E6 guideline. Ethical approval has been obtained by the lead ethics committee ‘Ethikkommission Nordwest- und Zentralschweiz’ (2023-00733, 22 May 2023). Ethical approval from local authorities will be sought for all participating sites. Regardless of outcomes, the findings will be published in a peer-reviewed medical journal. Metadata detailing the dataset’s type, size and content will be made available, along with the full study protocol and case report forms, in public repositories in compliance with the Findability, Accessibility, Interoperability and Reuse principles. Trial registration number NCT05890677 .
This article discusses legal issues related to the abortion provisions of the Transitional Penal Code of Eritrea. As is the case in many African countries, the current abortion law of Eritrea mainly was adopted from continental Europe four decades ago, reflecting the reality of the time. Despite the advancement in science and technology, which significantly determines the very definition and concept of abortion and contraception, the abortion law remains the same, save for minor amendments taken place in 1991. Due to the background of the abortion law and the shortcomings occurred during the amendment process, the law manifests legal gaps and limitations resulting in discrepancies between law and practice. The article, therefore, identifies and analyses the gaps of the abortion law in light of principles of criminal law, existing medical technology related to abortion, and experience of other countries.
Abstract Capsular contracture is a painful deformation of scar-tissue that may form around an implant in post-breast cancer reconstruction or cosmetic surgery. Inflammation due to surgical trauma or contamination in the tissue around the implant could account for recruitment of immune cells, and transdifferentiation of resident fibroblasts into cells that deposit abnormally thick collagen. Here we examine this hypothesis using a mathematical model for interacting macrophages, fibroblasts, myofibroblasts, and collagen. Our model demonstrates that cellular response can, together with inflammatory cell recruitment, account for prognoses.
Following an all-night fast, 45 patients with Parkinson9s disease were examined using certain motor items present in the United Parkinson9s Disease Rating Scale. All were given a single tablet of carbidopa 25 mg and levodopa 250 mg and re-examined 90 minutes later. In addition to this evaluation, 23 of these patients underwent further scoring over a 4-hour period. A significant negative correlation was found between age and one important aspect of drug-derived benefit: magnitude of response. In contrast, age had no apparent influence on duration of benefit from the drug. Although baseline (fasting) scores were predictably correlated with duration of disease, magnitude of response was not adversely influenced by this variable. Not all Parkinsonian signs were equally influenced by age. Whereas the poor response of gait and bradykinesia appeared to be dependent on age, no such effect was noted on rest tremor scores. The data indicate that in patients with Parkinson9s disease treated long term, factors associated with age rather than duration of disease may have a stronger adverse influence on magnitude of response to levodopa.
Cranio-orbital remodeling aims to correct the dysmorphic skull associated with craniosynostosis. Traditionally, the skull is reconstructed into a shape that is subjectively normal according to the surgeon's perception. We present a novel technique using a mathematical algorithm to define the optimal location for bony osteotomies and to objectively reshape the fronto-orbital bar into an ideal normal skull contour. Using pre-operative computed tomography images, the abnormal skull contour at the frontal-orbital region was obtained for infants planned to undergo cranio-orbital remodeling. The ideal skull shape was derived from an age- and sex-matched normative skull library. For each patient, the mathematical technique of dynamic programming (DP) was applied to compare the abnormal and ideal skull shapes. The DP algorithm identifies the optimal location of osteotomy sites and calculates the objective difference in surface area remaining between the normative and dysmorphic skull shape for each solution applied. By selecting the optimal solution with minimal objective difference, the surgeon is guided to reproducibly recreate the normal skull contour with defined osteotomies. The DP algorithm was applied in 13 cases of cranio-orbital remodeling. Five female and 8 male infants with a mean age of 11 months were treated for craniosynostosis classified as metopic (n = 7), unicoronal (n = 4), or bicoronal (n = 2). The mean OR time was 190.2 min (SD 33.6), mean estimated blood loss 244 cc (SD 147.6), and 10 infants required blood transfusions. Compared with a historical crania-orbital remodeling group treated without application of the algorithm, there was no significant difference in OR time, estimated blood loss, or transfusion rate. This novel technique enables the craniofacial surgeon to objectively reshape the fronto-orbital bar and reproducibly reconstruct a skull shape resembling that of normal infants.
OBJECTIVE Comparative effectiveness studies are needed for analyzing the clinical outcomes of treatment of sagittal craniosynostosis (SC) with endoscopic suturectomy (ES) or cranial vault remodeling (CVR). METHODS From 2004–2015, patients were consecutively reviewed and data recorded for operative details and complications. Cranial growth was measured by head circumference percentile (HCP) and cranial index (CI) Z-score. Aesthetic outcomes were compared using the Whitaker classification. RESULTS A total of 207 patients with nonsyndromic SC were treated with ES (n = 187) or CVR (n = 20). The ES group had a lower median operative duration (45 vs 195 minutes), length of stay (1 vs 3 days), and transfusion rate (2% vs 85%; p < 0.0001). Median age at follow-up was 3.0 years (interquartile range [IQR] 2.5–4.5, ES) and 3.9 years (IQR 2–5, CVR; p = 0.12). In both groups, HCP gradually decreased during a 3-year follow-up (p = 0.282). CI Z-scores were initially more favorable in the ES group (p < 0.05); 3 years following surgical intervention, Z-scores were equal between groups (p = 0.392). One nonsyndromic patient treated with ES (0.5%) demonstrated reossification and required secondary expansion. Most patients were Whitaker class I (99% of ES, 95% of CVR); 5% of CVR patients were class II and 1% of ES patients were class III. Four syndromic patients presented without clear evidence of a syndrome, were treated by ES, and subsequently required secondary expansion for raised intracranial pressure. CONCLUSIONS ES is an effective treatment for nonsyndromic SC with comparable head growth, aesthetic outcomes, and less morbidity relative to CVR. In the absence of a syndrome, secondary cranial expansion following ES is rarely required.
