Many Syrian refugees residing in Germany have been exposed to traumatizing events, while treatment options are scarce. Therefore, the self-help app “Sanadak” was developed to target post-traumatic stress in Syrian refugees. We aimed to inspect the recruitment and baseline characteristics of the participants in the trial, which is conducted to evaluate the app. Analyses were based on the recruitment sample (n = 170) and the trial sample (n = 133). Data were collected during structured face-to-face interviews in the Arabic language. Targeted outcomes included post-traumatic stress (primary; Post-traumatic Diagnostic Scale for DSM-5/PDS-5) and depressive symptoms, anxiety, resilience, among others (secondary). Recruited individuals were M = 32.8 (SD = 11.2, range = 18–65) years old; 38.8% were women. The average PDS-5 score was 23.6 (SD = 13.2) regarding trauma exposure, which was most frequently related to experiencing military- or combat-related events (32.9%). Moreover, 46.5% had major depression and 51.8% showed low resilience. Anxiety was present in 40.6% of the trial participants. Psychological distress was high in Syrian refugees residing in Germany, enrolled in a trial targeting post-traumatic stress. This underlines the need for intervention. Our results provide important figures on the mental health of a not well-studied population group in Germany.

Background: To explore cross‐sectional and longitudinal differences in general health‐related and prostate cancer‐specific quality of life (QoL) after robotic‐assisted (RARP) and laparoscopic (LRP) radical prostatectomy and to analyze predictive variables for QoL outcomes. Methods: In this multicenter, randomized controlled trial, prostate cancer patients were randomly assigned 3:1 to undergo either RARP or LRP. Patient‐reported outcomes were prospectively collected before and 1, 3, 6, 12 months after radical prostatectomy and included QoL as a secondary outcome. Validated questionnaires were used to assess general health‐related (EORTC QLQ‐C30) and prostate cancerspecific (QLQ‐PR25) QoL. Cross‐sectional and longitudinal contrasts were analyzed through linear mixed models. Predictive variables for QoL outcomes were identified by general linear modeling. Results: Of 782 randomized patients, QoL was evaluable in 681 patients. In terms of general QoL, the cross‐sectional analysis showed only small differences between study arms, whereas longitudinal comparison indicated an advantage of RARP on recovery: RARP patients reported an earlier return to baseline in global health status (3 vs. 6 months) and social functioning (6 vs. 12 months). In role functioning, only the RARP arm regained baseline scores. Regarding prostate‐specific QoL, LRP patients experienced more urinary symptoms and reported 3.2 points (95% confidence interval 0.4–6, p = 0.024) higher mean scores at 1‐month follow‐up and in mean 2.9 points (0.1–5, p = 0.042) higher urinary symptoms scores at 3‐month follow‐up than RARP patients. There were no other significant differences between treatment groups. Urinary symptoms, sexual activity, and sexual function remained significantly worse compared with baseline at all time points in both arms. Conclusions: Compared with LRP, the robotic approach led to an earlier return to baseline in several domains of general health‐related QoL and better short‐term recovery of urinary symptoms. Predictive variables such as the scale‐specific baseline status and bilateral nerve‐sparing were confirmed.:1 Abkürzungsverzeichnis 3 2 Einführung 4 2.1 Das Prostatakarzinom 4 2.1.1 Vorsorge und Diagnostik 4 2.1.2 Grundsätze der Therapie 5 2.1.3 Die radikale Prostatektomie 6 2.2 Lebensqualität 8 2.2.1 Gesundheitsbezogene Lebensqualität 8 2.2.2 Lebensqualität von Prostatakarzinompatienten 9 2.2.3 Prädiktoren der Lebensqualität nach radikaler Prostatektomie 12 2.3 Die LAP-01 Studie 13 2.3.1 Studiendesign 13 2.3.2 Lebensqualität im Rahmen der LAP-01 Studie 15 2.4 Zielsetzung und Fragestellung 16 3 Publikationsmanuskript 17 4 Zusammenfassung der Arbeit 28 5 Literaturverzeichnis 33 6 Anlagen 39 6.1 EORTC QLQ-C30 39 6.2 EORTC QLQ-PR25 42 7 Darstellung des eigenen Beitrags 44 8 Selbstständigkeitserklärung 45 9 Lebenslauf 46 10 Danksagung 48

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Plusieurs études ont démontré que prés de deux tiers des patients subissant une chirurgie cardiaque souffrent de douleur d’intensité modérée à sévère. Ces niveaux de douleur semblent être partiellement expliqués par la présence de barrières individuelles face au soulagement de la douleur. Le savoir acquis sur les cognitions associées à la douleur ne semble pas avoir été traduit dans de nouvelles approches éducatives face à la douleur aiguë. Le but du projet doctoral était 1) de développer une intervention visant à faciliter l’autogestion de la douleur postopératoire après une chirurgie cardiaque et, 2) d’en évaluer l’acceptabilité et la faisabilité, ainsi que le potentiel d’efficacité sur le soulagement de la douleur de patients subissant une chirurgie cardiaque. Le développement de l’iintervention SOULAGE-TAVIE a inclus quatre étapes fondées sur les savoirs clinique, empirique et théorique et inspirées de plusieurs écrits méthodologiques. SOULAGE-TAVIE consiste en une session préopératoire éducative sur la gestion de la douleur post-chirurgie cardiaque d’approximativement 30 minutes sur un ordinateur, dispensée sur mesure en fonction d’un algorithme. Deux renforcements cliniques en personne sont aussi offerts en phase postopératoire. L’évaluation de l’intervention consistait en un essai clinique pilote à répartition aléatoire incluant 60 participants répartis entre le groupe expérimental (GE : SOULAGE-TAVIE) et le groupe contrôle (GC : soins usuels incluant un feuillet d’information). Les données étaient recueillies au moment de l’admission et dans les sept jours postopératoires. SOULAGE-TAVIE a été jugée comme acceptable et faisable. De plus, les participants du GE n’ont pas expérimenté une douleur de plus faible intensité mais ils ont rapporté significativement moins d’interférence de la douleur avec la toux et la respiration profonde, ont démontré moins de barrières face à la gestion de la douleur et ont consommé plus d’opiacés. Cette étude pilote procure des résultats prometteurs sur les bénéfices potentiels de cette nouvelle approche sur mesure utilisant les technologies de l’information et de la communication (TIC). L’autonomisation des personnes est cruciale et complémentaire pour soutenir le soulagement de la douleur dans le contexte actuel de soins. / Several studies have shown that many patients undergoing a cardiac surgery suffer from moderate to severe pain. These levels of pain may be explained by individual barriers toward pain relief. Knowledge acquired on pain-related cognitions has not been translated into new approaches. The aim of the doctoral project was 1) to develop an intervention to facilitate the self-management of postoperative pain after cardiac surgery and, 2) to assess its the acceptability and feasibility and to investigate its efficacy potential on pain relief in patients undergoing cardiac surgery. The development of SOULAGE-TAVIE included four steps based on clinical, empirical and theoretical knowledge and inspired by diverse methodological considerations. SOULAGE-TAVIE consists in a 30-minute computer-tailored preoperative educational session about postoperative pain management, tailored according to an algorithm. Two short reinforcements are provided in person. The evaluation of SOULAGE-TAVIE consisted in a pilot randomized controlled trial including 60 participants assigned to the experimental group (EG: SOULAGE-TAVIE) and the control group (CG: usual care including educational pamphlet). Data were collected at the time of admission and across Day 1 to 7 after surgery. The results provide preliminary support for the acceptability and feasibility of a tailored and virtual intervention. The results revealed that patients of the EG did not experience less intense pain but they reported significantly less pain interference when breathing/coughing, exhibited fewer pain-related barriers, and consumed more opioid medication. This pilot study provides promising results to support the potential benefits of this new web-tailored approach. Patient empowerment is complementary yet crucial in the current context of care and may contribute to improve pain relief.

Introduction: Les instillations nasales de solution saline isotonique (INSS) chez les enfants sont recommandées par les pédiatres et des oto-rhino-laryngologistes de notre institution dans le but de prévenir les otites moyennes aigues à répétition (OMAr). Cependant, aucune étude dans la littérature ne vient corroborer ou infirmer cette pratique. Objectifs: Déterminer l’efficacité des INSS dans la prévention des OMAr. Méthode: Projet pilote d’un essai clinique randomisé. Les enfants diagnostiqués avec des OMAr étaient éligibles. Les patients recrutés ont été randomisés en 2 groupes. Seul le groupe traitement procède aux INSS. L’issue primaire est l’incidence d’OMAr pendant une période de 3 mois. Résultats: Vingt-neuf patients satisfaisant les critères d’inclusion et d’exclusion ont consenti à participer. Le taux d’OMAr était inférieur dans le groupe traitement (p=0.03, chi-carré) Conclusion: Les INSS semblent efficaces dans la prévention des OMAr. Une étude multicentrique est indiquée pour vérifier la validité externe et confirmer la sécurité. / Introduction: Normal saline nasal cavity irrigations (NSNI) are commonly recommended by pediatricians and otolaryngologists to prevent recurrent acute otitis media (rAOM). However, no published scientific study corroborates or invalidates this practice. Goal: To determine the efficacy of NSNI to prevent rAOM. Method: Pilot randomized controlled clinical trial. All consecutive patients with a diagnosis of rAOM were eligible. Recruited patients were randomized in 2 groups. Only patients in the treatment group proceeded with NSNI. The primary outcome of the study was the incidence of rAOM observed during a 3 month period. Results: Twenty-nine patients met the inclusion and exclusion criteria and agreed to participate. There was a statistically significant lower incidence of rAOM in the treatment group (p=0.003, Fisher exact). Conclusion: Our results suggest that NSNI could effectively prevent rAOM. A larger scale randomized multicentre study is feasible, and it must be done in order to verify for external validity and to properly assess safety issues.

Problématique : Les prématurés évoluent dans l’unité néonatale qui présente une intensité lumineuse parfois forte et variable, ce qui a pour effet de provoquer une instabilité physiologique, ainsi qu’une augmentation du niveau d’activité motrice chez ces derniers. Par ailleurs, le contrôle de l’éclairage à l’unité néonatale favorise la stabilité physiologique et réduit le niveau d’activité motrice des prématurés. Deux méthodes de contrôle de l’éclairage ont été étudiées, soit l’éclairage tamisé constant et l’éclairage cyclique. Or, la méthode de contrôle de l’éclairage la plus appropriée au système nerveux immature des prématurés est inconnue et il y a ambivalence en ce qui concerne les résultats des études ayant évalué ces deux modes de contrôle de l’éclairage. But : Le but de cette étude était de mesurer les effets de l’éclairage cyclique versus l’éclairage tamisé constant sur la stabilité physiologique et le niveau d’activité motrice de prématurés nés entre 28 et 32 semaines d’âge gestationnel. Méthode : Un essai clinique randomisé a été réalisé. Les 38 prématurés recrutés dans une unité néonatale de niveaux II et III d’un hôpital universitaire, ont été randomisés dans l’un des deux groupes d’intervention, soit le groupe exposé à l’éclairage tamisé constant ou celui exposé à l’éclairage cyclique. Ces deux types d’éclairage ont été appliqués pendant 24 heures. La stabilité physiologique a été mesurée par le score Stability of the Cardio Respiratory System in Premature Infants (SCRIP) et le niveau d’activité motrice a été mesuré avec un accéléromètre (Actiwatch®). L’intensité lumineuse à laquelle les prématurés ont été exposés a été mesurée de façon continue à l’intérieur de l’incubateur à l’aide d’un photomètre. Résultats : L’analyse des données révèle qu’il n’y aucune différence significative entre les deux groupes d’intervention en ce qui a trait à la stabilité physiologique (valeur-p du score SCRIP de 0,54 à 0,96) et au niveau d’activité motrice (valeur-p de 0,09 à 0,88). Les participants des deux groupes ont manifesté une stabilité physiologique et un niveau d’activité motrice comparables. Conclusion : Des interventions de contrôle de l’éclairage doivent être adoptées à l’unité néonatale, que ce soit des interventions qui permettent la mise en œuvre de l’éclairage cyclique ou de l’éclairage tamisé constant, dans le but de favoriser l’adaptation du prématuré à l’environnement de l’unité néonatale. Des recherches additionnelles sont requises afin d’identifier la méthode de contrôle de l’éclairage (éclairage cyclique ou éclairage tamisé constant) qui doit être implantée à l’unité néonatale. / Problem statement: After birth, preterm infants evolve in the neonatal intensive care unit (NICU) characterized by a high and variable lighting which differs significantly from the dimmed intra-uterine environment. Exposure to high or variable NICU lighting can create physiological instability in preterm infants as well as increasing their motor activity level. An appropriate control of the NICU lighting can prevent the adverse effects of exposing infants to inadequate levels of lighting. To date, it appears that two methods of lighting control have been discussed and studied: near dark lighting and cycled lighting. At the same time, it is acknowledged that there is ambiguity about the results of studies which have evaluated these two NICU lighting methods. Therefore, the optimal NICU lighting remains unknown and further research is needed to identify the lighting mode witch promote preterm infant’s adaptation to the NICU environment. Purpose: The objective of this research was to evaluate the effects of cycled lighting versus near dark lighting on the physiological stability and motor activity level of preterm infants born between 28 and 32 weeks of gestation. Methods: A randomized controlled trial (RCT) allowed the assessment of preterm infants' physiological stability and motor activity level. 38 preterm infants born between 28 to 32 weeks of gestational age were recruited from a level II and III NICU university affiliated hospital. Each infant were randomly allocated to one of the following groups for 24 hours: cycled lighting or near dark lighting. Physiological stability was assessed by the SCRIP score, while the motor activity level was evaluated by an accelerometer (Actiwatch®). The light intensity level was continuously measured with a light meter to ensure that the lighting mode assigned was respected. Results: The analysis conducted indicates no significant difference between the two intervention groups in regard to physiological stability (score SCRIP = p-value 0.54 to 0.96) and the motor activity level (p- value 0.09 to 0.88). This lack of significant difference between the two groups indicates that the participants in the two groups demonstrated a comparable physiological stability state and a comparable level of motor activity when exposed to near dark lighting or cycled lighting. Conclusion: Guidelines to decrease bright light, either near dark or cycled light should be adopted in NICUs to control preterm infant’s’ exposure to light. Further research is required to identify the method of lighting control (cycled lighting or near dark lighting) which should be implanted in the neonatal unit.

INTRODUÇÃO: Pacientes com rigidez pós-traumática do cotovelo que falharam à fisioterapia convencional têm como possibilidades de tratamento protocolos de reabilitação associado ao uso de órtese ou à liberação cirúrgica do cotovelo. Na literatura não existem artigos comparativos entre essas duas formas de tratamento. O objetivo primário deste estudo foi comparar a amplitude de movimento de flexoextensão do cotovelo entre os pacientes submetidos ao tratamento cirúrgico ou à reabilitação. Os objetivos secundários foram comparar os resultados clínicos, de acordo com a escala \"Mayo Elbow Performance Score\", o questionário \"Disability of Arm, Shoulder and Hand\" e a escala visual analógica de dor, além de comparar o ganho absoluto e relativo da flexoextensão, a flexão e extensão máxima, a amplitude de pronossupinação e a taxa de complicações. MÉTODOS: Estudo clínico randomizado, com avaliador cego, de pacientes com rigidez póstraumática do cotovelo que apresentaram falha ao tratamento fisioterápico convencional. Os pacientes foram alocados aleatoriamente em dois grupos de tratamento: conservador e cirúrgico. O grupo conservador foi submetido ao protocolo de reabilitação envolvendo a equipe de terapia ocupacional, com exercícios e alongamentos associados ao uso de órteses estáticas seriadas de extensão, dinâmicas de flexão, além de sessões de movimentação contínua passiva. O grupo cirúrgico foi submetido à liberação cirúrgica por via posterior, seguido do mesmo protocolo de reabilitação do grupo conservador. As escalas clínicas foram aplicadas pré-operatoriamente, aos 3 e 6 meses de seguimento. A amplitude de movimento foi avaliada nos mesmos períodos e adicionalmente com 6 semanas. As complicações foram avaliadas até os 6 meses de tratamento. O desfecho primário do estudo foi a amplitude de movimento de flexoextensão aos 6 meses de seguimento. RESULTADOS: Trinta pacientes foram incluídos no estudo, sendo 15 em cada grupo. A amplitude de movimento de flexoextensão do cotovelo, ao final dos 6 meses de seguimento, foi de 108,4º para o grupo cirúrgico e de 88,1º para o grupo conservador (p=0,002). O ganho absoluto e relativo da flexoextensão do cotovelo aos 6 meses foram respectivamente de 17,2º e 26,8% para o grupo conservador e de 40,8º e 58,8% para o grupo cirúrgico (p < 0,001). A pontuação da escala visual analógica de dor, escala \"Mayo Elbow Performance Score\" e o questionário \"Disability of Arm, Shoulder and Hand\" foram respectivamente de 4,4, 70,6 e 35,3 para o grupo conservador e de 3,9, 77,3 e 27,6 para o grupo cirúrgico (p=0,486, p=0,342 e p=0,361). O grupo conservador apresentou uma complicação, enquanto o grupo cirúrgico quatro (p=0,598). CONCLUSÕES: A liberação cirúrgica do cotovelo associada ao protocolo de reabilitação resultou em uma maior amplitude de flexoextensão, além de um maior ganho absoluto e relativo quando comparada à reabilitação isolada após 6 meses. A extensão máxima obtida foi superior no grupo cirúrgico, sem diferença para a flexão máxima e amplitude de movimento de pronossupinação. Os grupos não diferiram nas escalas funcionais e na taxa de complicações / INTRODUCTION: Patients with post-traumatic elbow stiffness who have failed conventional physiotherapy have two options of treatment: rehabilitation protocols associated with the use of bracing or surgical elbow release. In the literature there are no comparative studies between those forms of treatment. The primary objective of this study was to compare the elbow flexion-extension range of motion between patients submitted to surgical treatment or rehabilitation. The secondary objectives were to compare the clinical outcomes according to the Mayo Elbow Performance Score, the Disability of Arm, Shoulder and Hand questionnaire and the visual analogue pain scale, in addition to comparing the absolute and relative gain of elbow flexion-extension, maximal flexion and extension, pronosupination range of motion and complications rate. METHODS: Randomized clinical trial with blind evaluator of patients with post-traumatic elbow stiffness who presented failure to conventional physiotherapeutic treatment. Patients were randomly assigned to two treatment groups: non surgical and surgical. The non surgical group was submitted to a rehabilitation protocol involving the occupational therapy team, with exercises and stretching associated with the use of serial extension static braces, dynamics braces and continuous passive movement sessions. The surgical group was submitted to surgical release, followed by the same protocol of rehabilitation of the non surgical group. The clinical scales were applied preoperatively, at 3 and 6 months of follow-up. The range of motion was assessed at the same periods and additionally at 6 weeks. Complications were assessed up to 6 months of treatment. The study primary outcome was the flexion-extension range of motion at 6 months of follow-up. RESULTS: Thirty patients were included in the study, 15 in each group. The elbow flexion-extension range of motion at 6 months of follow-up was 108.4º for the surgical group and 88.1º for the non surgical group (p=0.002). The absolute and relative gain of elbow flexion-extension at 6 months were 17.2º and 26.8% for the non surgical group and 40.8º and 58.8% for the surgical group (p < 0.001). The visual analogue pain scale, the Mayo Elbow Performance Score and the Disability of Arm, Shoulder and Hand questionnaire were respectively 4.4, 70.6 and 35.3 for the non surgical group and 3.9, 77.3 and 27.6 for the surgical group (p=0.486, p=0.342 and p=0.361). The non surgical group presented one complication, while the surgical group had four (p=0.598). CONCLUSIONS: The elbow surgical release associated with the rehabilitation protocol resulted in a greater flexion-extension range of motion and greater absolute and relative gain when compared to the isolated rehabilitation after 6 months. The maximal extension obtained was superior in the surgical group, with no difference for maximal flexion and pronosupination range of motion. The groups did not differ on functional scales and complication rates

INTRODUÇÃO: A clonidina é um agonista seletivo do receptor adrenérgico alfa2 com propriedades sedativas, analgésicas e possibilita a redução do consumo de outros anestésicos. Suas ações podem mitigar o impacto hemodinâmico e psíquico da S+ Cetamina. Os grandes queimados são de difícil manejo e ainda não existe uma técnica anestésica padrão para estes pacientes, sendo a cetamina amplamente utilizada nestes pacientes em regimes muito variados, apresentando várias vantagens. Os objetivos do estudo foram avaliar os efeitos hemodinâmicos e psíquicos da interação da clonidina e da S+ cetamina e propor uma técnica anestésica para grandes queimados. MÉTODOS: O estudo foi prospectivo, duplo encoberto, aleatório e placebo controlado, planejado para 48 pacientes adultos grandes queimados, estado físico ASA II ou III, que foram agendados para trocas de curativos ou debridamentos cirúrgicos. Para a anestesia foi usado midazolam 0,07mg/kg e duas doses de 1 mg/kg de S+ cetamina. No Grupo Clonidina foi usada a dose de 2 mcg/kg e soro fisiológico no Grupo Placebo. Foram avaliadas as alterações hemodinâmicas durante o intra-operatório. Durante as duas primeiras horas foram avaliadas detalhadamente as alterações psíquicas utilizando 13 variáveis, o retorno da consciência, a analgesia e a ocorrência de complicações. Após 24 horas foram avaliadas a analgesia, a ocorrência de sonhos e delírios. RESULTADOS: O Grupo Clonidina apresentou redução estatisticamente significativa nas pressões arteriais durante o procedimento. Dentre as 13 variáveis psíquicas analisadas, 5 foram menores com significância estatística no Grupo Clonidina durante a avaliação de 30 minutos, incluindo Corpo, Arredores, Pensamento, Sonolento e Ansioso. Na avaliação de duas horas, apenas a variável Ansioso teve redução estatisticamente significativa no Grupo Clonidina. A frequência cardíaca, a ocorrência de delírio e sonhos e a analgesia pós-operatória foram similares nos dois grupos. Não houve diferença entre os grupos na ocorrência de complicações. CONCLUSÃO: O uso de Clonidina em anestesia para pacientes grandes queimados, com S+ cetamina e midazolam reduz as pressões arteriais durante o procedimento e os efeitos psíquicos, sem aumentar a ocorrência de complicações / Abstract: Clonidine is a selective alpha2-adrenoceptor agonist with sedative, analgesic and anesthetic sparing properties. Because of its sympathoinhibitory activity, it may reduce the hemodynamic and psychic effects of S+ ketamine and improve analgesia. The ketamine is commonly used in burned patients worldwide. The objectives of this study were to evaluate the interactions between clonidine and ketamine in hemodynamic and psychic effects and also to propose an anesthetic technique for major burned patients. Method: A prospective, double-blind, placebo controlled study designed for 48 patients with major burns, aged 18-60 years, physical status ASA II or III, that were scheduled for dressing changes and wound debridements. For the anesthesia was used midazolam 0,07mg/kg, two doses of S+ ketamine 1 mg/kg, placebo or clonidine 2mcg/kg. Intraoperative hemodynamic alterations over time were assessed. During the first two hours after the procedures were evaluated, psychic effects in detail using 13 variables, the return of conscience, analgesia, dreaming and delirium and after 24 hours, analgesia, dreaming and delirium. Results: The Clonidine Group had low arterial pressure during the procedure. At the 30 minute evaluation of the psychic variables 5 out of 13 were lower in the Clonidine Group with statistically significance, these being Body, Surroundings, Thoughts, Drowsy and Anxious. At the 2 hour evaluation only the Anxious variable was lower in the Clonidine Group with statistically significance. Cardiac frequency, postoperative analgesia, occurrence of delirium and dreaming weren\'t different between both groups. There wasn\'t any difference in complication rates between both groups. Conclusion: We concluded that the use of Clonidine in S+ ketamine plus midazolam anesthesia in patients with major burns reduces the arterial pressures and the postoperative psychic effects, without increasing the complications

INTRODUÇÃO: As fraturas do terço médio da clavícula representam 80% das fraturas claviculares e seu tratamento é motivo de discussão na literatura ortopédica. Estudos prévios relativos ao tratamento cirúrgico têm demonstrado bons resultados clínicos com o uso das placas de reconstrução ou a fixação intramedular elástica estável com hastes flexíveis de titânio. O objetivo deste estudo foi a comparação desses métodos no tratamento das fraturas do terço médio da clavícula, quanto aos resultados funcionais, parâmetros radiográficos, dor pós-operatória, taxa de satisfação e taxa de complicações. MÉTODOS: Neste ensaio clínico comparativo, prospectivo e randomizado, 59 pacientes com fratura desviada do terço médio da clavícula foram alocados aleatoriamente para receberem osteossíntese com placa de reconstrução (33 pacientes - grupo Placa) ou haste flexível de titânio (26 pacientes - grupo Haste). O desfecho primário do estudo foi a avaliação funcional pelo escore DASH aos 6 meses de pós-operatório. Os desfechos secundários foram: o escore DASH aos 12 meses; o escore de Constant- Murley aos 6 e 12 meses; o tempo de consolidação da fratura; o encurtamento residual; o nível de dor pela escala visual analógica no 1º pósoperatório; a taxa de pacientes satisfeitos e a taxa de complicações. RESULTADOS: Cinquenta e quatro pacientes completaram o seguimento, sendo 29 do grupo Placa e 25 do grupo Haste. O escore DASH médio aos 6 meses foi de 9,9 pontos no grupo Placa e 8,5 no grupo Haste, sem diferença estatisticamente significante (p = 0,329). Da mesma forma, não houve diferenças significantes no escore DASH aos 12 meses ou no escore de Constant aos 6 e 12 meses. O tempo de consolidação foi equivalente entre os grupos (p = 0,352), enquanto o encurtamento residual foi maior no grupo Placa, com significância estatística (p = 0,032), mas sem relevância clínica (0,4 cm). Os resultados da escala visual analógica para dor no 1º pósoperatório e a taxa de pacientes satisfeitos foram similares entre os grupos. O grupo Placa apresentou mais casos com angulação do implante (11 casos) do que o grupo Haste (um caso) (p = 0,003), enquanto o grupo Haste foi mais associado à dor relacionada ao implante (10 casos), em comparação ao grupo Placa (4 casos) (p = 0,035). Não houve diferenças significantes entre os grupos quanto às complicações maiores, incluindo falha do implante, infecção pós-operatória, pseudoartrose e reoperação. CONCLUSÕES: A osteossíntese das fraturas desviadas do terço médio da clavícula com placa de reconstrução ou haste flexível de titânio produzem resultados semelhantes quanto aos escores funcionais, tempo de consolidação, dor pós-operatória, satisfação dos pacientes e complicações maiores. As placas de reconstrução são mais suscetíveis à angulação do implante, enquanto as hastes flexíveis de titânio causam mais dor relacionada ao implante / INTRODUCTION: Midshaft clavicle fractures represent 80% of all clavicular fractures, and their treatment is controversial in the literature. Previous studies have shown good clinical results in patients with midshaft clavicular fractures treated with reconstruction plate fixation or elastic stable intramedullary nailing (ESIN). The objective of this study was to compare these methods in terms of functional results, radiographic parameters, postoperative pain, satisfaction rates and complication rates. METHODS: In this prospective, randomized, controlled trial, 59 patients with displaced midshaft clavicular fractures were randomly assigned to receive either reconstruction plate (33 patients - Plate group) or ESIN fixation (26 patients - ESIN group). The primary outcome was the DASH score at 6 months. The secondary outcomes were the following: DASH score at 12 months; Constant-Murley scores at 6 and 12 months; time to fracture union; residual shortening; visual analog scale for pain on the first post-operative day; percentage of satisfied patients; and complications rates. RESULTS: Fifty-four patients completed the follow-up, 29 in the Plante group and 25 in the ESIN group. The mean DASH score at 6 months was 9.9 in the plate group and 8.5 in the ESIN group, with no significant difference (p = 0.329). Similarly, there were no differences in the DASH score at 12 months or the Constant-Murley scores at 6 and 12 months. The time to union was equivalent between the groups (p = 0.352), whereas the residual shortening was significantly greater in the plate group (p = 0.032) but was not clinically relevant (0.4 cm). The visual analog scale scores for pain and the percentage of satisfied patients were similar between the groups. Implant bending was significantly more common in the plate group (eleven patients) than in the ESIN group (one patient) (p = 0.003), whereas hardware-related pain was more frequent in the ESIN group (10 patients vs. 4 patients) (p = 0.035). There were no differences in terms of major complications, including implant failure, postoperative infection, nonunion and reoperation. CONCLUSIONS: Reconstruction plates and ESIN yielded similar results in terms of functional results, time to union, post-operative pain, patient satisfaction and major complications in patients with displaced midshaft clavicular fractures. Reconstruction plates are more susceptible to implant bending, whereas ESIN causes more hardwarerelated pain

INTRODUÇÃO: O câncer de próstata (CaP) é o tipo mais comum entre os tumores malignos que afetam o homem. Dentre as opções terapêuticas para o tratamento precoce do CaP, destaca-se o tratamento cirúrgico com resultados satisfatórios de até 94% de cura nos casos localizados. A ressecção cirúrgica do CaP pode ser feita por três abordagens principais: prostatectomia radical retropúbica (PRR), prostatectomia radical laparoscópica (PRL) e mais recentemente a prostatectomia radical laparoscópica robô assistida (PRAR). Uma vez que existem várias alternativas terapêuticas para esse tipo de câncer, a qualidade de vida e satisfação relacionadas à avaliação, tornam-se muito importantes nos diferentes tipos de técnicas cirúrgicas. OBJETIVO: Comparar a qualidade de vida e o índice de satisfação nos pacientes submetidos a PRR e PRAR através de um estudo prospectivo e aleatorizado. MATERIAL E MÉTODOS: Através do Sistema Único de Saúde (SUS), 200 pacientes com diagnóstico de adenocarcinoma de próstata localizado, foram selecionados de forma aleatória para participarem do estudo, sendo então encaminhados entre março de 2010 a janeiro de 2011 para o Hospital Alemão Oswaldo Cruz (HAOC) para realizar PRAR, ou para o Instituto do Câncer do Estado de São Paulo (ICESP), para a realização de PRR. Todos os pacientes foram seguidos clinicamente de maneira padrão. Utilizamos questionário SF-36 da seguinte forma: no pré-operatório e no pós-operatório de 1, 3, 6, 12, 18 e 24 meses, além de outro elaborado para avaliar a satisfação dos pacientes no pós operatório de 6, 12 e 18 meses. Os dados obtidos foram avaliados estatisticamente com nível de significância de 5%. RESULTADOS: Foram então aplicados os questionários em 200 pacientes submetidos às cirurgias (grupos homogêneos com 100 pacientes para PRR e 100 para PRAR). De acordo com os domínios de qualidade de vida, os escores médios dos aspectos físicos, aspectos emocionais e saúde mental só variaram estatisticamente entre os momentos de avaliação, sendo os grupos iguais entre si para estes domínios. De acordo com aspectos sociais houve diferença entre os grupos independente do momento de avaliação, sendo maior nos pacientes submetidos a cirurgia aberta (p = 0,016). O nível de escolaridade e a renda familiar dos pacientes que realizaram a cirurgia robótica são maiores que as dos pacientes que realizaram a cirurgia aberta (p = 0,044 e p = 0,029 respectivamente). De acordo com o grau de satisfação pós cirurgia, encontramos que os pacientes que fizeram cirurgia robótica apresentam um maior grau de satisfação com a cirurgia que aqueles submetidos a cirurgia aberta (p < 0,001). O que mais incomoda ou preocupa o paciente que realiza a cirurgia aberta é a disfunção erétil enquanto que nos pacientes que fazem à cirurgia robótica a preocupação se distribui entre cura, impotência e perda urinária. CONCLUSÃO: Demonstramos que a maioria dos aspectos de qualidade de vida são semelhantes entre os pacientes submetidos a PRR e PRAR com exceção dos aspectos sociais que foram maiores nos pacientes submetidos ao procedimento aberto, demonstramos ainda que o índice de satisfação dos pacientes é maior no procedimento robótico, entretanto a grande maioria dos pacientes realizariam o mesmo tratamento quando questionados / INTRODUCTION: Prostate cancer (PCa) is the most common malignant tumors that affect man. Among the treatment options for early treatment of PCa, stands out the surgical treatment with satisfactory results, achieving cure results of up to 94% in localized cases. Surgical resection of PCa can be done through three main approaches, which are radical retropubic prostatectomy (RRP), laparoscopic radical prostatectomy (LRP) and more recently robotic-assisted laparoscopic radical prostatectomy (RALRP). Since there are several alternative therapies for this cancer, quality of life and satisfaction related to the evaluation of different types of surgery became very important. OBJECTIVE: Evaluate the two most widely used techniques: RRP and RALRP through a prospective randomized study, checking the satisfaction and quality of life in patients who have undergone these treatments. MATERIAL AND METHODS: The choice of surgical approach of the patient occurred randomly and the patients were selected through the Unified Health System (SUS) and sent to the Oswaldo Cruz Hospital (HAOC) for RALRP (robotic-assisted laparoscopic radical prostatectomy) or sent to the Cancer Institute of the State of São Paulo (ICESP) for RRP (radical retropubic prostatectomy), between March 2010 and January 2011. All patients were followed clinically in a standard way through a questionnaire, SF-36 and a questionnaire to evaluate their satisfaction. It was also verified the level of regret in post-surgery within 1, 3, 6, 12 and 24 months and the level of satisfaction was verified at 6 12 and 18 months post-surgery. The data were statistically evaluated with a significance level of 5%. RESULTS: We then applied the questionnaires in 200 patients who underwent surgery, and 100 patients who underwent RRP and 100 patients who underwent RALRP. The groups were quite homogeneous. According to the domains of quality of life, the average scores of physical, emotional and mental health only varied significantly among time points of evaluation, and the groups were equal to each other for these domains. According to the social aspects there were differences between the groups regardless of the time of evaluation, being higher in patients who underwent open surgery (p = 0.016). The education level and family income of patients who underwent robotic surgery are higher than of patients who underwent open surgery (p = 0.044 and p = 0.029 respectively). According to the level of satisfaction post-surgery, we realized that robotic surgery patients have a higher level of satisfaction about the surgery than those undergone open surgery (p < 0.001). The most signicant thing that bothers or worries the open surgery patients is sexual impotence while in robotic surgery patients, the concern is distributed among cure, impotence and urinary incontinence. CONCLUSION: We demonstrated that most aspects of quality of life are similar among patients undergoing RRP and RALRP except social aspects that were higher in patients undergone open surgery. We further demonstrated that the rate of satisfaction is higher in the robotic procedure patients. However, when questioned, the vast majority of patients would do the same treatment