Systematic and continuous collection of patient-reported outcomes and experience in women with cancer undergoing mastectomy and immediate breast reconstruction: a study protocol for the Tuscany Region (Italy)

Introduction: Monitoring how patients feel and what they experience during the care process gives health professionals data to improve the quality of care, and gives health systems information to better design and implement care pathways. To gain new insights about specific gaps and/or strengths in breast cancer care, we measure patient-reported outcomes (PROs) and patient-reported experiences (PREs) for women receiving immediate breast reconstruction (iBR). Methods and analysis: Prospective, multicentre, cohort study with continuous and systematic web-based data collection from women diagnosed with breast cancer, who have an indication for iBR after mastectomy treated at any Breast Unit (BU) in Tuscany Region (Italy). Patients are classified into one of two groups under conditions of routine clinical practice, based on the type of iBR planned (implant and autologous reconstruction). Patient-reported information are obtained prior to and after surgery (at 3-month and 12-month follow-up). We estimate that there are around 700 annual eligible patients.Descriptive analyses are used to assess trends in PROs over time and differences between types of iBR in PROs and PREs. Additionally, econometric models are used to analyse patient and BU characteristics associated with outcomes and experiences. PREs are evaluated to assess aspects of integrated care along the care pathway. Ethics and dissemination: The study has been reviewed and obtained a nihil obstat from the Tuscan Ethics Committees of the three Area Vasta in 2017. Dissemination of results will be via periodic report, journal articles and conference presentations

Robot-assisted surgery for the radical treatment of deep infiltrating endometriosis with colorectal involvement: short- and mid-term surgical and functional outcomes.

Sexual and urinary dysfunctions are complications in radical treatment of deep infiltrating endometriosis (DIE) with colorectal involvement. The aim of this article is to report the preliminary results of our single-institution experience with robotic treatment of DIE, evaluating intraoperative and postoperative surgical outcomes and focusing on the impact of this surgical approach on autonomic functions such as urogenital preservation and sexual well-being. METHODS: From January 2011 through December 2013, a case series of 10 patients underwent robotic radical treatment of DIE with colorectal resection using the da Vinci System. Surgical data were evaluated, together with perioperative urinary and sexual function as assessed by means of self-administered validated questionnaires. RESULTS: None of the patients reported significant postoperative complications. Questionnaires concerning sexual well-being, urinary function, and impact of symptoms on quality of life demonstrated a slight worsening of all parameters 1 month after surgery, while data were comparable to the preoperative period 1 year after surgery. Dyspareunia was the only exception, as it was significantly improved 12 months after surgery. CONCLUSIONS: Robot-assisted surgery seems to be advantageous in highly complicated procedures where extensive dissection and proper anatomy re-establishment is required, as in DIE with colorectal involvement. Our preliminary results show that robot-assisted surgery could be associated with a low risk of complications and provide good preservation of urinary function and sexual well-being

Hand-assisted hybrid laparoscopic–robotic total proctocolectomy with ileal pouch–anal anastomosis

PURPOSE: Few studies have reported minimally invasive total proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC) and familial adenomatous polyposis (FAP). We herein report a novel hand-assisted hybrid laparoscopic-robotic technique for patients with FAP and UC. METHODS: Between February 2010 and March 2014, six patients underwent hand-assisted hybrid laparoscopic-robotic total proctocolectomy with IPAA. The abdominal colectomy was performed laparoscopically with hand assistance through a transverse suprapubic incision, also used to fashion the ileal pouch. The proctectomy was carried out with the da Vinci Surgical System. The IPAA was hand-sewn through a trans-anal approach. The procedure was complemented by a temporary diverting loop ileostomy. RESULTS: The mean hand-assisted laparoscopic surgery (HALS) time was 154.6 (±12.8) min whereas the mean robotic time was 93.6 (±8.1) min. In all cases, a nerve-sparing proctectomy was performed, and no conversion to traditional laparotomy was required. The mean postoperative hospital stay was 13.2 (±7.4) days. No anastomotic leakage was observed. To date, no autonomic neurological disorders have been observed with a mean of 5.8 (±1.3) bowel movements per day. CONCLUSIONS: The hand-assisted hybrid laparoscopic-robotic approach to total proctocolectomy with IPAA has not been previously described. Our report shows the feasibility of this hybrid approach, which surpasses most of the limitations of pure laparoscopic and robotic techniques. Further experience is necessary to refine the technique and fully assess its potential advantages

Endothelial function as a marker of pre-clinical atherosclerosis: assessment techniques and clinical implications

Endothelium plays a key role in maintenance of vascular homeostasis. Cardiovascular risk factors promote development of endothelial dysfunction, characterized by increased vasoconstriction and by procoagulant/pro-inflammatory endothelial activities. In coronary artery, endothelium-dependent dilation improves blood flow, while the occurrence of endothelial dysfunction reduces myocardial perfusion, so new methods have been developed for assessment of endothelial function in coronary and peripheral arteries. The quantitative angiography with intracoronary infusion of acetylcholine remains the “gold standard” to assess the endothelium-dependent vasodilatation. The use of this technique is restricted to patients who have a clinical indication for coronary angiography, so new imaging methods have been considered for noninvasive diagnosis of coronary microvascular disease, such as magnetic resonance imaging phase contrast and positron emission tomography. The advent of new techniques has facilitated testing of endothelial dysfunction in peripheral arteries with non-invasive methods. This review presents available invivo and ex-vivo methods for evaluating endothelial function with special focus on more recent ones. The diagnostic tools include local vasodilatation by venous occlusion plethysmography and assessment of flow-mediated dilatation, arterial pulse wave analysis and pulse amplitude tonometry, laser Doppler flowmetry. The possibility to detect endothelial dysfunction as an early marker of atherosclerosis makes these instruments useful for early stratification of patients at risk for cardiovascular events. Aim of this review is to summarize the characteristics of non-invasive assessment of endothelial function in order to optimize cardiovascular risk management

The impact of immediate breast reconstruction on the time to delivery of adjuvant therapy: the iBRA-2 study

Background: Immediate breast reconstruction (IBR) is routinely offered to improve quality-of-life for women requiring mastectomy, but there are concerns that more complex surgery may delay adjuvant oncological treatments and compromise long-term outcomes. High-quality evidence is lacking. The iBRA-2 study aimed to investigate the impact of IBR on time to adjuvant therapy. Methods: Consecutive women undergoing mastectomy ± IBR for breast cancer July–December, 2016 were included. Patient demographics, operative, oncological and complication data were collected. Time from last definitive cancer surgery to first adjuvant treatment for patients undergoing mastectomy ± IBR were compared and risk factors associated with delays explored. Results: A total of 2540 patients were recruited from 76 centres; 1008 (39.7%) underwent IBR (implant-only [n = 675, 26.6%]; pedicled flaps [n = 105,4.1%] and free-flaps [n = 228, 8.9%]). Complications requiring re-admission or re-operation were significantly more common in patients undergoing IBR than those receiving mastectomy. Adjuvant chemotherapy or radiotherapy was required by 1235 (48.6%) patients. No clinically significant differences were seen in time to adjuvant therapy between patient groups but major complications irrespective of surgery received were significantly associated with treatment delays. Conclusions: IBR does not result in clinically significant delays to adjuvant therapy, but post-operative complications are associated with treatment delays. Strategies to minimise complications, including careful patient selection, are required to improve outcomes for patients

Ruolo della chirurgia ascellare nel carcinoma mammario:revisione della letteratura e partecipazione ad uno studio sperimentale multicentrico prospettico randomizzato

Il trattamento dell'ascella è stato una parte fondamentale della chirurgia del carcinoma mammario sin dalle sue origini rivestendo un ruolo curativo, stadiativo e prognostico.Per lungo tempo essa è consistita esclusivamente nella dissezione ascellare radicale. Nel corso degli ultimi anni si è tuttavia assistito ad un sostanziale cambiamento nell'approccio all'ascella conseguente al ridimensionamento progressivo del suo ruolo ed inquadrabile nel processo di de-escalation dei trattamenti chirurgici del carcinoma mammario in generale. Attualmente, in un'era caratterizzata dall'implementazione sempre più diffusa di trattamenti multimodali che prevedono l'utilizzo di terapie sistemiche e locali sempre più efficaci,è riconosciuto al trattamento chirurgico radicale dell'ascella un ruolo sempre meno importante. La chirurgia ascellare è per lo più identificata con la biopsia del linfonodo sentinella, che non si associa più a dissezione radicale non solo nelle pazienti con ascella negativa ma anche in quelle con ascella micrometastatica e, secondo le linee guida ASCO vigenti negli Stati Uniti, anche in quelle con ascella paucimentastatica (massimo due linfonodi sentinella positivi).Numerosi studi sono attualmente in corso anche in Europa per l'implementazione anche nelle nostre linee guida,di questi ulteriori cambiamenti nelle indicazioni chirurgiche. Lo studio a cui abbiamo preso parte è uno studio multicentrico prospettico randomizzato chiamato SINODAR ONE che randomizza le pazienti con ascella clinicamente negativa,tumori T1-2 ed un massimo di 2 linfonodi sentinella positivi, a dissezione o a follow-up

Ruolo della chirurgia nel trattamento dell'adenocarcinoma duttale del pancreas localmente avanzato

Il carcinoma del pancreas è una delle neoplasie più aggressive, con un tasso di mortalità che quasi eguaglia quello di incidenza. L'approccio terapeutico a questo tumore è necessariamente multimodale ma l'unica opzione terapeutica che offre una realistica possibilità di cura è rappresentata dalla chirurgia resettiva. Questa è il trattamento di scelta nelle forme localizzate mentre è controindicata nelle forme con metastasi a distanza. Attualmente è invece in corso un acceso dibattito in merito alla opportunità e validità oncologica del suo utilizzo nei pazienti con diagnosi di carcinoma pancreatico localmente avanzato. Premessa essenziale è che attualmente non esiste una definizione precisa e unanimamente condivisa di carcinoma localmente avanzato e questo comporta la mancanza di uniformità di gestione di questi pazienti. Essi infatti, a seconda dei centri cui afferiscono, vengono trattati con la sola terapia palliativa, analogamente ai pazienti con metastasi a distanza, o con la chirurgia resettiva in associazione o meno a terapie neoadiuvanti o adiuvanti. Questo dato rispecchia il fatto che, ancora troppo frequentemente, la decisione circa l'approccio terapeutico a tali pazienti venga presa a discrezione del centro o addirittura del chirurgo piuttosto che in base a criteri standardizzati. Numerosi sforzi sono stati effettuati per cercare di 'reclutare' la popolazione di pazienti con carcinoma localmente avanzato e tra questi possiamo ricordare l'impiego di terapie neoadiuvanti o il ricorso ad approcci chirurgici più aggresivi che comprendano le resezioni vascolari in associazione alla pancreaticoduodenectomia. Infatti mentre i pazienti con carcinoma del pancreas localmente avanzato vengono ritenuti in genere candidabili alla chirurgia anche in presenza di invasione degli organi adiacenti o di metastasi linfonodali, nonostante la mancanza di informazioni prognostiche affidabili, il coinvolgimento dei principali vasi peripancreatici è considerato una controindicazione alla resezione. Questo perchè gli interventi di resezione pancreatica associati a resezione vascolare sono ritenuti tecnicamente complessi ed associati ad elevata morbilità, mortalità e scarsa sopravvivenza a lungo termine. Tuttavia se questo era vero in passato, attualmente, grazie ai progressi nelle tecniche chirurgiche e nella gestione dei pazienti è quantomeno opinabile se non, in alcuni casi, non più sostenibile. Numerose evidenze si sono accumulate in letteratura in merito alla fattibilità, sicurezza ed efficacia delle resezioni vascolari soprattutto per quanto concerne le resezioni venose della vena porta, della vena mesenterica superiore e della confluenza mesenterico-portale. Dati più controversi riguardano le resezioni arteriose, in merito alle quali ancora numerosi autori esprimono riserve,perquanto anche in questo campo gli studi condotti nei centri ad alto volume sembrano indicare che l'invasione arteriosa isolata non controindichi in modo assoluto la resezione. Piuttosto unanumi sono invece le conclusioni in merito ai tumori che coinvolgono più vasi dal momento che le resezioni artero-venose sono effettivamente associate ad elevato rischio di complicanze, elevata mortalità postoperatoria ed insoddisfacente sopravvivenza a lungo termine; ciò suggerisce che l'invasione di multipli vasi peripancreatici sia espressione dei 'reali' tumori localmente avanzati che non beneficiano della resezione. Fermo restando dunque che il carcinoma del pancreas rimane una delle neoplasie più aggressive e con peggiore prognosi, i progressi in ambito chirurgico e l'aumento di centri ad alto volume che si occupano di chirurgia pancreatica consentono potenzialmente di triplicare l'impatto della chirurgia sul tumore ed offrono anche ai pazienti con diagnosi di neoplasia localmente avanzata una reale chance di cura

Implant of a reabsorbable scaffold in non-malignant breast lesions treated by excision or lumpectomy: A First In Human pilot study

My PhD study is a pre-market, single center, interventional, open label, non-comparative, pilot first-in-human study on adult female patients with non-malignant breast lesions up to 200 cc in volume, eligible for lumpectomy. The aim is to determine safety and feasibility of an innovative breast reconstructive approach after conservative surgery. This consists of an in vivo tissue engineering approach based on the combination of conservative surgery and a biodegradable polyurethane cell-free scaffold intended for regenerating soft tissue resembling fat. The purpose is to acquire preliminary information on this biomimetic device to design an adequate development plan. Albeit on a very limited number of patients treated, the data collected showed a positive outcome both in terms of safety and performance. This is significant because based on the quantity of breast tissue that must be removed, conservative surgery may not always be able to obtain satisfactory cosmetic results unless resorting to more complex oncoplastic techniques. Therefore, having an alternative technique that optimizes the aesthetic outcomes while minimizing surgical invasiveness, duration, and complexity, is highly desirable. This innovative breast reconstructive approach represents an alternative to current surgical options, being able to restore a natural breast in a single step, safe, easy-to-adopt, and potentially cost-saving procedure. Furthermore, it can have remarkable impact on research and clinical application of tissue engineering to bulky, highly vascularized tissues. Further analysis on a larger sample and with a longer follow-up is necessary to confirm these results

Robotic giant hiatal hernia repair: 3 year prospective evaluation and review of the literature

Background While conventional laparoscopic repair for giant hiatal hernias is considered difficult, robotic technology is likely to result in an improved postoperative course. Methods We prospectively analysed patients with giant hiatal hernias who underwent robotic repair during a 3 year period. Preoperative data, operative variables, complications, clinical outcomes and anatomical recurrence after 1 year were evaluated. Results Six patients with giant hiatal hernias underwent robotic repair using the Da Vinci surgical system. The mean operative time was 182 min. The mean hospital stay was 6 days. No patients required reoperation for disease recurrence, and all claimed the absence of postoperative symptoms. Conclusions Robotic approaches can minimize surgical trauma in patients with giant hiatal hernias and result in favourable outcomes in terms of anatomical recurrence and quality of life. With the availability of the da Vinci System, all patients with giant hiatal hernias can be offered a minimally invasive surgical option