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BACKGROUND: The BODY-Q is a widely used patient-reported outcome measure for comprehensive assessment of treatment outcomes specific to patients undergoing body contouring surgery (BCS). However, for BODY-Q to be meaningfully interpreted and used in clinical practice, minimal important difference (MID) scores are needed. A MID is defined as the smallest change in outcome measure score that patients perceive important. OBJECTIVES: The aim of this study was to determine BODY-Q MID estimates for patients undergoing BCS to enhance the interpretability of the BODY-Q. METHODS: Data from an international, prospective cohort from Denmark, Finland, Germany, Italy, the Netherlands, and Poland were included. Two distribution-based methods were used to estimate MID: 0.2 standard deviations of mean baseline scores and the mean standardized response change of BODY-Q scores from baseline to 3 years postoperatively. RESULTS: A total of 12,554 assessments from 3,237 participants (mean age; 42.5±9.3 years; body mass index; 28.9±4.9 kg/m2) were included. Baseline MID scores ranged from 1 to 5 in the health-related quality of life (HRQL) scales and 3 to 6 in the appearance scales. The estimated MID scores from baseline to 3 years follow-up ranged from 4 to 5 in HRQL and from 4 to 8 in the appearance scales. CONCLUSIONS: The BODY-Q MID estimates from before BCS to 3 years postoperatively ranged from 4 to 8 and are recommended for use to interpret patients' BODY-Q scores, evaluate treatment effects of different BCS procedures, and for calculating sample size for future studies.
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Background and Objective: Perforator flaps have revolutionized autologous breast reconstruction, introducing both free and pedicled options as well as the potential for combining flaps. These versatile techniques can be utilized in massive weight loss (MWL) patients, effectively addressing both functional and aesthetic challenges by using their excess skin. This review aims to explore literature on combined pedicled and free perforator flaps for total breast reconstruction, and share our own experience in the field. Methods: A PubMed search up to June 2023 employed Medical Subject Headings (MeSH) terms such as (("combined") OR ("stacked") OR ("conjoined") AND ("perforator flaps")) AND ("breast reconstruction"). Publications in English and Scandinavian languages were manually screened for relevance, and supplemental sources were also reviewed. Key Content and Findings: Limited studies exist on using combined pedicled and free flaps for total breast reconstruction, although combined free flaps are more common. Perforators around the breast base, offer multiple flap options for single or combined use. In our series of 10 women, four underwent total breast reconstruction with a combination of flip-over internal mammary artery perforator (IMAP) flap and thoracodorsal artery perforator (TDAP) flap. Another subset of four, who were MWL patients, received combined TDAP and superior epigastric artery perforator (SEAP) flaps, along with body contouring procedures such as upper body lifts and vertical abdominoplasties, addressing excess skin and improving silhouette. One remaining MWL patient had deflated breasts restored using TDAP and SEAP flaps, along with an upper and lower body lift and vertical abdominoplasty. The last MWL patient underwent a risk-reducing mastectomy, also reconstructed with TDAP and SEAP flaps, and received an upper body lift and vertical abdominoplasty. Conclusions: Combined perforator flap techniques for combined body contouring and breast reconstruction seems safe and especially suitable for MWL patients. They offer a surgical alternative merging body contouring and breast reconstruction in cases where free flap procedures seem less favorable due to skin laxity and deflation of donor sites. However, limited literature on the topic calls for further studies.
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Background: Various surgical treatments are increasingly adopted and gaining popularity for lymphedema treatment. However, challenges persist in selecting appropriate treatment modalities targeted for individual patients and achieving consensus on choice of treatment as well as outcomes. The systematic review aimed to create a treatment algorithm incorporating the latest scientific knowledge, to provide healthcare professionals and patients with a tool for informed decision-making, when selecting between treatments or combining them in a relevant manner. This systematic review evaluated and synthesized the evidence on the effectiveness of three surgical treatments for breast cancer-related lymphedema (BCRL): lymphovenous anastomosis (LVA), vascularized lymph node transfer (VLNT), and liposuction. Methods: We conducted a systematic search of electronic databases on 18 June 2023, including Medline, Embase, Cochrane Library, Google Scholar, and ClinicalTrials.org. Eligible studies were randomized controlled trials, non-randomized comparative studies, and observational studies that assessed the outcomes of LVA, VLNT, or liposuction in managing BCRL. The primary results of interest were changes in arm volume, lymphatic flow, and quality of life. Two independent reviewers performed the study selection and data extraction. Following this, we systematically reviewed and conducted a risk of bias assessment. Results were qualitatively presented, and a treatment algorithm was developed based on the available data. Results: We identified 16,593 papers, after removal of duplicates. Following assessment of studies, 73 articles met the inclusion criteria, including 2,373 patients. We were not able to conduct a meta-analysis due to considerable heterogeneity in the methodologies and outcome measures across the studies. Liposuction appears effective for patients presenting with non-pitting lymphedema. LVA indicates variable success rate, with some evidence indicating a reduction in limb volume and symptomatic relief amongst early stages of lymphedema. VLNT showed promising results for limb volume reduction and symptom improvement in patients presenting with mild and moderate lymphedema. Conclusions: Liposuction, LVA, and VLNT seem to be effective treatments for BCRL, when targeted for the appropriate patient. Well-conducted high evidence clinical studies in the field are still lacking to uncover the efficacy of surgical treatment for BCRL.
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We present the first-in-human robot-assisted microsurgery on a lymphocele in the groin involving a man in his late 60s who had been coping with the condition for 12 months. Despite numerous efforts at conservative treatment and surgical intervention, the lymphocele persisted, leading to a referral to our clinic.Diagnostic techniques, including indocyanine green lymphography and ultrasound, identified one lymphatic vessel draining into the lymphocele. The surgical intervention, conducted with the assistance of a robot and facilitated by the Symani Surgical System (Medical Microinstruments, Calci, Italy), involved a lymphovenous anastomosis and excision of the lymphocele. An end-to-end anastomosis was performed between the lymphatic and venous vessels measuring 1 mm in diameter, using an Ethilon 10-0 suture.The surgery was successful, with no postoperative complications and a prompt recovery. The patient was discharged 3 days postoperatively and exhibited complete recovery at the 14-day follow-up. This case marks the first use of robot-assisted microsurgical lymphovenous anastomosis to address a groin lymphocele, highlighting the benefit of advanced robotic technology in complex lymphatic surgeries.
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Anastomose Cirúrgica , Virilha , Vasos Linfáticos , Linfocele , Microcirurgia , Procedimentos Cirúrgicos Robóticos , Humanos , Linfocele/cirurgia , Masculino , Anastomose Cirúrgica/métodos , Procedimentos Cirúrgicos Robóticos/métodos , Virilha/cirurgia , Vasos Linfáticos/cirurgia , Vasos Linfáticos/diagnóstico por imagem , Microcirurgia/métodos , Linfografia/métodos , Pessoa de Meia-Idade , Veias/cirurgia , Resultado do TratamentoRESUMO
BODY-Q is a patient-reported outcome measure for comprehensive assessment of outcomes specific to patients undergoing bariatric surgery. The clinical utility of BODY-Q is hampered by the lack of guidance on score interpretation. This study aimed to determine minimal important difference (MID) for assessment of BODY-Q. Prospective BODY-Q data from Denmark and the Netherlands pre- and post-bariatric surgery were collected. Two distribution-based methods were used to estimate MID by 0.2 standard deviations of baseline scores and the mean standardized response change of scores from baseline to 3-years postoperatively. In total, 5476 assessments from 2253 participants were included of which 1628 (72.3%) underwent Roux-en-Y gastric bypass, 586 (26.0%) sleeve gastrectomy, 33 (1.5%) gastric banding, and 6 (0.03%) other surgeries. The mean age was 45.1 ± 10.9 with a mean BMI of 46.6 ± 9.6. Baseline MID ranged from 1 to 4 in health-related quality of life (HRQL) and from 2 to 8 in appearance scales. The mean change of scores ranged from 4 to 5 in HRQL and from 4 to 7 in the appearance scales. The estimated MID for the change in BODY-Q HRQL and appearance scales ranged from 3 to 8 and is recommended for use to interpret BODY-Q scores and assess treatment effects in bariatric surgery.
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OBJECTIVE: To examine health-related quality of life (HRQL) and satisfaction with appearance in patients who have undergone bariatric surgery (BS) with or without subsequent body contouring surgery (BCS) in relation to the general population normative for the BODY-Q. BACKGROUND: The long-term impact of BS with or without BCS has not been established using rigorously developed and validated patient-reported outcome measures. The BODY-Q is a patient-reported outcome measure developed to measure changes in HRQL and satisfaction with appearance in patients with BS and BCS. METHODS: Prospective BODY-Q data were collected from 6 European countries (Denmark, the Netherlands, Finland, Germany, Italy, and Poland) from June 2015 to February 2022 in a cohort of patients who underwent BS. Mixed-effects regression models were used to analyze changes in HRQL and appearance over time between patients who did and did not receive BCS and to examine the impact of patient-level covariates on outcomes. RESULTS: This study included 24,604 assessments from 5620 patients. BS initially led to improved HRQL and appearance scores throughout the first postbariatric year, followed by a gradual decrease. Patients who underwent subsequent BCS after BS experienced a sustained improvement in HRQL and appearance or remained relatively stable for up to 10 years postoperatively. CONCLUSIONS: Patients who underwent BCS maintained an improvement in HRQL and satisfaction with appearance in contrast to patients who only underwent BS, who reported a decline in scores 1 to 2 years postoperatively. Our results emphasize the pivotal role that BCS plays in the completion of the weight loss trajectory.
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Cirurgia Bariátrica , Contorno Corporal , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Qualidade de Vida , Humanos , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Longitudinais , Europa (Continente) , Obesidade Mórbida/cirurgia , Obesidade Mórbida/psicologiaRESUMO
Information technologies are increasingly used when informing patients about their disease, treatment and prognosis. These digital platforms have many advantages compared to traditional education interventions. However, there are concerns that some patients may have difficulty with this mode of information delivery. Newly diagnosed breast cancer patients are dependent on understanding their treatment options to make informed treatment decisions. Yet, there is a lack of published material on breast cancer patients and their relationship with technology. We aimed to assess health technology readiness profiles amongst women with a suspected breast cancer diagnosis. Secondly, we wanted to investigate the potential differences between these profiles according to sociodemographic factors and the patients´ current use of technology. This cross-sectional study used the Readiness and Enablement Index for Health Technology (READHY) questionnaire. We included all patients (n = 92) referred to our department with suspected breast cancer. Cluster analysis revealed three distinct profiles: medium (n = 54), high (n = 18), and low (n = 20) health technology readiness. The third profile showed difficulties in health literacy, eHealth literacy, and health insights, along with higher emotional stress. Our study found that most patients had medium to high health technology readiness, but we also identified a group with lower health technology readiness. Based on our results, healthcare personnel dealing with women with suspected breast cancer should be aware of patients struggling with health technology. Age and technology familiarity may indicate vulnerable patients. Future studies should explore optimal methods for information delivery to these distinct profiles and evaluate the long-term impacts.
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Neoplasias da Mama , Telemedicina , Humanos , Feminino , Estudos Transversais , Neoplasias da Mama/diagnóstico , Inquéritos e Questionários , Telemedicina/métodos , Pessoal de SaúdeRESUMO
INTRODUCTION: Dyspeptic symptoms belong to the most frequent reasons to seek medical advice and are a burden both for the individual affected and the healthcare system. In Japan, the traditional herbal Kampo prescription rikkunshito has proven benefit for this indication. METHODS: In a prospective, multicentre, non-interventional study (NIS), the effectiveness, safety, and tolerability of a two-week treatment with the registered rikkunshito extract product YamatoGast was assessed in German patients with an acute episode of dyspeptic symptoms of functional origin under real-world conditions. The primary endpoint was the responsiveness to treatment assessed by the overall treatment effect (OTE) score. Secondary endpoints were the change in severity of dyspeptic symptoms and the change in quality of life (QoL). Safety evaluation was based on reported adverse drug reactions, drug compliance, and ratings of tolerability by physicians and patients. RESULTS: Sixty-six patients were enrolled (mean age 48.9 years, 74% females). The treatment was well tolerated and highly beneficial, as expressed by pronounced responder rates of 78.9% for the primary endpoint OTE. All secondary endpoints were also met. The severity of dyspeptic symptoms significantly improved by 62-77% compared to baseline, confirmed by a remarkable improvement of QoL. Significant symptom relief started from the third day of treatment onwards. CONCLUSION: In this non-interventional study, two-week treatment with YamatoGast resulted in a significant improvement of dyspeptic symptoms and was associated with high patient response and satisfaction. YamatoGast was confirmed as a safe and clinically relevant therapeutic option for patients suffering upper gastrointestinal complaints in routine practice.
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BACKGROUND: Gastroesophageal reflux disease (GERD) is a common disease which in the majority of patients is treated with proton pump inhibitors (PPI). However, up to 45% of the patients remain symptomatic on a standard dose of PPI. This study investigated the effectiveness and safety of an add-on therapy with the gel-forming chewable tablet Sobrade® in patients unsatisfied with PPI treatment. The bioadhesive gel covers the oesophagus and thereby protects the mucosa from reflux events. METHODS: 47 patients with symptomatic GERD despite PPI treatment participated in this study. The gel-forming tablets were taken up to four times daily after meals and prior to bedtime. Severity and frequency of GERD symptoms were evaluated during two onsite visits prior and following 14 days of treatment and used to calculate the GERD score of the Reflux Disease Questionnaire. Furthermore, patients recorded symptoms as well as onset and duration of symptoms relief daily in their electronic dairies. Effectiveness of treatment was analysed using non-parametric paired Wilcoxon test. In addition, anchor-based minimal important differences (MID) were assessed. RESULTS: Treatment resulted in significant reduction of GERD symptoms. Severity and frequency of 8 of the 9 assessed symptoms improved significantly during the treatment phase whereby most pronounced improvement was observed for heartburn. In agreement, all three subscales of the GERD score improved significantly. MID results suggest that patients considered a mean improvement of symptoms > 30% of initial severity as beneficial. Self-assessments by patients revealed first significant improvements of symptoms like heartburn and regurgitation from day 5 of treatment onwards. 49% of patients reported relief of symptoms within 15 min which lasted on average for 3.5 h. During the study no treatment emergent adverse events were reported and in 98% of all cases tolerability of the product was rated as very good or good. CONCLUSIONS: This study revealed a pronounced improvement of the symptoms after add-on treatment with the gel-forming medical device. The very good safety and tolerability profile indicate an advantageous risk-benefit ratio. TRIAL REGISTRATION: This non-interventional study was prospectively positively evaluated by the responsible ethic-committees.
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Refluxo Gastroesofágico , Inibidores da Bomba de Prótons , Humanos , Estudos Prospectivos , Inibidores da Bomba de Prótons/efeitos adversos , Ácido Hialurônico/efeitos adversos , Azia/tratamento farmacológico , Azia/etiologia , Refluxo Gastroesofágico/tratamento farmacológico , ComprimidosRESUMO
Background: Augmented reality (AR) technology, exemplified by devices such as the Microsoft HoloLens 2, has gained interest for its potential applications in preoperative guidance. This study explores the use of AR technology for perforator identification during deep inferior epigastric artery perforator (DIEP) flap breast reconstruction. Methods: A case series of five patients where an AR device was used to identify perforators during DIEP flap breast reconstruction is presented. The device was utilized to recognize preoperative perforators and map their extra- and intramuscular routes. Sound and/or color Doppler confirmation was used to verify the findings. Results: In all five cases, the AR device successfully identified preoperative perforators and delineated their extra- and intramuscular routes. AR technology in perioperative visualization of vasculature offers the potential to enhance surgical precision and reduce operative times. By providing an augmented three-dimensional overlay of patients' vascular structures, AR can facilitate a more comprehensive understanding of individual anatomy, ultimately improving surgical outcomes. Conclusions: AR technology shows promise in enhancing perforator identification efficiency and deepening understanding of perforator trajectories during preoperative planning. Nonetheless, additional research is needed to establish whether the advantages of AR technology warrant its widespread adoption for perforator identification.
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ChatGPT is an open artificial intelligence chat box that could revolutionize academia and augment research writing. This study had an open conversation with ChatGPT and invited the platform to evaluate this article through series of five questions on base of thumb arthritis to test if its contributions and contents merely add artificial unusable input or help us augment the quality of the article. The information ChatGPT-3 provided was accurate, albeit surface-level, and lacks analytical ability to dissect for important limitations about base of thumb arthritis, which would not be conducive to potentiating creative ideas and solutions in plastic surgery. ChatGPT failed to provide relevant references and even "created" references instead of indicating its inability to perform the task. This highlights that as an AI-generator for medical publishing text, ChatGPT-3 should be used cautiously.
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BACKGROUND: Postherpetic neuralgia (PHN) is a chronic pain syndrome occurring after a herpes zoster outbreak. While there is no effective treatment available today, autologous fat grafting has shown promise. This randomized controlled trial investigated the effectiveness of fat grafting as treatment for PHN compared with a sham treatment. METHODS: A total of 46 participants with PHN were included. After liposuction under general anesthesia, participants were randomly assigned to receive either autologous fat grafting or saline injection to the area of pain. The primary outcomes were the average and maximum degree of pain measured on an 11-point numeric rating scale. Secondary outcomes were quality and degree of neuropathic pain (Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey). RESULTS: Forty-two participants completed follow-up of 6 months. For maximal degree of pain, a reduction of -1.1 ± 0.6 and -1.0 ± 0.5 mean change (±SE) on the numeric rating scale was observed in the intervention and control groups, respectively. For average degree of pain, the reduction was -1.2 ± 0.5 and -1.3 ± 0.4 in the intervention and control groups, respectively. The authors did not observe any significant changes in the neuropathic pain and quality-of-life parameters. For all measured outcomes, the differences between the groups were not statistically significant. CONCLUSIONS: The authors did not find autologous fat grafting superior to a placebo when treating PHN of the skin. Given their results, they cannot recommend the routine use of this method to treat these pains. CLINICAL RELEVANCE STATEMENT: Since autologous fat grafting was not proven to be more effective than a placebo in treating PHN, alternative treatment options should be explored. It is also essential to emphasize the importance of prophylactic vaccination against herpes zoster. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
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Herpes Zoster , Neuralgia Pós-Herpética , Neuralgia , Humanos , Tecido Adiposo , Herpes Zoster/complicações , Herpes Zoster/tratamento farmacológico , Neuralgia/tratamento farmacológico , Neuralgia Pós-Herpética/terapia , Neuralgia Pós-Herpética/complicações , Qualidade de Vida , Método Duplo-CegoAssuntos
Neoplasias da Mama , Dor Crônica , Mamoplastia , Humanos , Feminino , Mastectomia , Transplante Autólogo , Tecido Adiposo/transplanteRESUMO
Background: Inguinal lymph node dissection (ILND) is associated with a high complication rate. Retrospective studies suggest that incisional negative pressure wound therapy (iNPWT) might reduce complications, especially seroma, following ILND. Methods: This was a prospective multicenter, randomized (1:1), open-labeled, parallel-group trial. Patients with macrometastic melanoma to the inguinal lymph nodes and eligible for ILND were randomized to receive either iNPWT for 14 postoperative days or conventional wound dressing. The primary outcome was seroma incidence. Secondary outcomes included surgical-site infection, wound rupture, wound necrosis, hematoma, rehospitalization and readmission rates between groups. All outcomes were registered 3 months after ILND and analyzed according to the intention-to-treat principle. Results: The trial was terminated early due to a low recruitment rate as a consequence of a change in the national treatment protocol, and the estimated sample size was not reached. Twenty patients were included and randomized in the study. The trial showed less seroma formation between the iNPWT 6/11 (55%) and control 7/9 (78%) groups; however, this was not statistically significant (p = 0.29). Similarly, there were no differences in the rates of surgical-site infection (p = 0.63), wound rupture (p = 0.19), wound necrosis (p = 0.82), hematoma (p = 0.19), reoperation (p = 0.82) or readmission (p = 0.34) between groups. Conclusion: There was a tendency toward fewer complications in the iNPWT group, however this trial was underpowered and could not confirm the hypothesis that iNPWT reduces complications after ILND. Future randomized controlled trials are required to fully evaluate the treatment potential of iNPWT. Trial registration: The trial was prospectively registered at https://clinicaltrials.gov/ct2/show/NCT03433937.
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Background The incidence of breast animation deformity (BAD) is reported to be substantial after direct-to-implant breast reconstruction with subpectoral implant placement. It has, however, never been examined if BAD can occur following prepectoral implant placement. Our primary aim was to compare the incidence and degree of BAD after direct-to-implant breast reconstruction using either subpectoral or prepectoral implant placement. Secondary aim of this study was to assess and compare the level of pain between sub- and prepectoral reconstructed women. Methods In this randomized controlled trial, patients were allocated to reconstruction by either subpectoral or prepectoral implant placement in accordance with the CONSORT guidelines. The degree of BAD was assessed by the "Nipple, Surrounding skin, Entire breast (NSE)" grading scale 12 months after surgery. The level of postoperative pain was assessed on a numerical pain rating scale. Results We found a significant difference in the degree of BAD favoring patients in the prepectoral group (23.8 vs. 100%, p < 0.0001; mean NSE grading scale score: 0.4 vs. 3.6, p < 0.0001). The subpectoral reconstructed group reported higher levels of pain on the three subsequent days after surgery. No significant difference in pain levels could be found at 3 months postoperatively. Conclusion The incidence and degree of BAD was significantly lower in women reconstructed by prepectoral direct-to-implant breast reconstruction. Unexpectedly, we found mild degrees of BAD in the prepectoral group. When assessing BAD, distortion can be challenging to discern from rippling.
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The anterolateral thigh (ALT) flap is widely used in the reconstruction of a variety of soft tissue defects. Descriptions of patients with severe obesity in the literature are scarce. We report a case where a reverse pedicled fasciocutaneous ALT flap was successfully used for resurfacing of a knee defect measuring 12×6 cm in a patient with a body mass index (BMI) of 47.3. The flap was supercharged to the greater saphenous vein to optimise flap survival. Reconstruction of the soft tissue of the knee was achieved as planned. There were no flap or donor site complications.
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Obesidade Mórbida , Procedimentos de Cirurgia Plástica , Humanos , Joelho/cirurgia , Obesidade Mórbida/complicações , Obesidade Mórbida/cirurgia , Retalhos Cirúrgicos/irrigação sanguínea , Coxa da Perna/cirurgiaRESUMO
BACKGROUND: Variability in breast reconstruction methods provides an opportunity to investigate whether a method is superior to another with regard to cost, quality, or both. We performed a cost-effectiveness analysis (CEA) study based on tertiary endpoint data from a randomized clinical trial to compare the cost-effectiveness of delayed breast reconstruction by either a latissimus dorsi flap (LD) or a thoracodorsal artery perforator flap (TAP). MATERIAL & METHODS: A total of 50 women were included for unilateral delayed breast reconstruction and were randomized to reconstruction by either the LD flap (n = 18) or the TAP flap (n = 22). The CEA was based on differences in shoulder function after the reconstruction. Direct and indirect costs relating to the two procedures were assessed by the Danish Diagnosis-Related Groups tariffs. RESULTS: Our analysis showed a significant positive effect of introducing the TAP flap on the total shoulder score with an additional cost of $2779. The incremental cost-effectiveness ratio was $4481 and based on a willingness to pay (WTP) $500, we found an estimated net benefit of $519, which was statistically significant (p = 0.0375). The cost-effectiveness acceptability curve indicated that there is a 96.3% probability for the TAP flap being cost-effective to the LD flap at a WTP threshold of $500. CONCLUSION: From a societal perspective, our cost-effective analysis demonstrated that the TAP flap is the more cost-effective method of breast reconstruction compared to the LD flap with respect to patient-reported shoulder-related disability.
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Mamoplastia , Retalho Perfurante , Músculos Superficiais do Dorso , Artérias , Análise Custo-Benefício , Feminino , Humanos , Mamoplastia/métodos , Retalho Perfurante/irrigação sanguínea , Músculos Superficiais do Dorso/transplante , Extremidade SuperiorRESUMO
INTRODUCTION: Enhancement of mucociliary clearance (MCC) might be a potential target in treating COVID-19. The phytomedicine ELOM-080 is an MCC enhancer that is used to treat inflammatory respiratory diseases. PATIENTS/METHODS: This randomised, double-blind exploratory study (EudraCT number 2020-003779-17) evaluated 14 days' add-on therapy with ELOM-080 versus placebo in patients with COVID-19 hospitalised with acute respiratory insufficiency. RESULTS: The trial was terminated early after enrolment of 47 patients as a result of poor recruitment. Twelve patients discontinued prematurely, leaving 35 in the per-protocol set (PPS). Treatment with ELOM-080 had no significant effect on overall clinical status versus placebo (p = 0.49). However, compared with the placebo group, patients treated with ELOM-080 had less dyspnoea in the second week of hospitalisation (p = 0.0035), required less supplemental oxygen (p = 0.0229), and were more often without dyspnoea when climbing stairs at home (p < 0.0001). CONCLUSION: These exploratory data suggest the potential for ELOM-080 to improve respiratory status during and after hospitalisation in patients with COVID-19.
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COVID-19 , Insuficiência Respiratória , COVID-19/complicações , Método Duplo-Cego , Dispneia/tratamento farmacológico , Dispneia/etiologia , Humanos , Estudos Prospectivos , Insuficiência Respiratória/tratamento farmacológico , SARS-CoV-2 , Resultado do TratamentoRESUMO
Massive weight loss (MWL) results in significant changes of the female breast becoming deflated, ptotic and flat in the upper pole. It may cause physical discomfort such as infections, intertrigo and psychological discomfort including reduced health-related quality of life, where subsequent corrective surgery of the breast is indicated. In this review, we outline our experiences of the most commonly used surgical techniques for correction of the breast in women after MWL. We highlight the principles of the various surgical techniques.