ASL, DSC, DCE perfusion MRI and 18F-DOPA PET/CT in differentiating glioma recurrence from post-treatment changes.

OBJECTIVES: To discriminate between post-treatment changes and tumor recurrence in patients affected by glioma undergoing surgery and chemoradiation with a new enhancing lesion is challenging. We aimed to evaluate the role of ASL, DSC, DCE perfusion MRI, and 18F-DOPA PET/CT in distinguishing tumor recurrence from post-treatment changes in patients with glioma. MATERIALS AND METHODS: We prospectively enrolled patients with treated glioma (surgery plus chemoradiation) and a new enhancing lesion doubtful for recurrence or post-treatment changes. Each patient underwent a 1.5T MRI examination, including ASL, DSC, and DCE PWI, and an 18F-DOPA PET/CT examination. For each lesion, we measured ASL-derived CBF and normalized CBF, DSC-derived rCBV, DCE-derived Ktrans, Vp, Ve, Kep, and PET/CT-derived SUV maximum. Clinical and radiological follow-up determined the diagnosis of tumor recurrence or post-treatment changes. RESULTS: We evaluated 29 lesions (5 low-grade gliomas and 24 high-grade gliomas); 14 were malignancies, and 15 were post-treatment changes. CBF ASL, nCBF ASL, rCBV DSC, and PET SUVmax were associated with tumor recurrence from post-treatment changes in patients with glioma through an univariable logistic regression. Whereas the multivariable logistic regression results showed only nCBF ASL (p = 0.008) was associated with tumor recurrence from post-treatment changes in patients with glioma with OR = 22.85, CI95%: (2.28-228.77). CONCLUSION: In our study, ASL was the best technique, among the other two MRI PWI and the 18F-DOPA PET/CT PET, in distinguishing disease recurrence from post-treatment changes in treated glioma.

Recurrent pelvic prolapse after pelvic organ prolapse suspension (POPS): Analysis and treatment of an emerging clinical issue.

OBJECTIVES: To investigate pelvic organ prolapse (POP) after a novel abdominal prosthetic surgical technique - 'pelvic organ prolapse suspension' (POPS) - that has been proposed recently as an easily reproducible laparoscopic technique for the treatment of multicompartmental POP and rectal prolapse. This study also aimed to analyse treatment strategies of recurrent POP after POPS, reporting on anatomical, subjective and functional outcomes following recurrence surgery. METHODS: Patients with a symptomatic prolapse relapse after POPS were collected and analysed prospectively at a single tertiary care institution. Each patient was offered a multidisciplinary clinical and radiological evaluation pre-operatively. RESULTS: Twenty-five women with a median age of 59 [interquartile range (IQR) 49-73] years were enrolled in the study. Of these, 88 % were menopausal. All patients had high-grade (Pelvic Organ Prolapse Quantification System stage > 2) recurrent posterior vaginal wall-predominant prolapse after POPS. Multicompartmental prolapse was found in 64 % of patients. All women complained of vaginal bulging associated with obstructed defaecation syndrome (ODS) symptoms. Surgical treatment consisted of laparoscopic ventral rectopexy (VR) in all 25 cases (100 %), and concomitant sacral colpopexy (SCP) with previous mesh removal in 16 cases (64 %). No anatomical recurrences were observed after median follow-up of 12 (IQR 3-18) months. Overall subjective improvement after surgery was high in all patients (Patient Global Improvement Index ≤ 2). CONCLUSIONS: Recurrent POP following POPS appears to predominantly involve the posterior vaginal wall, with associated ODS symptoms. A multidisciplinary approach is advisable for treatment of these patients. Minimally invasive VR alone or in combination with SCP seems to represent an effective treatment.

Nutritional Trends in Cystic Fibrosis: Insights from the Italian Cystic Fibrosis Patient Registry.

Background: Over the past decades, efforts have been made to improve the nutritional well-being of people with cystic fibrosis (pwCF). Due to the correlation observed between nutritional indices and lung function, prevailing recommendations consistently advocate for BMI percentile goals at or above the 50th percentile in pwCF. Recent global trends show a notable increase in overweight and obese statuses among pwCF. This study aims to explore the nutritional status of Italian pwCF. Methods: Data from the Italian CF Patient's Registry were analysed to assess the proportion of individuals categorized as underweight, target weight, overweight, and obese from 2010 to 2021. Patient-level comparison data from 2021 were also examined to identify the potential determinants of overweight and obesity. Results: Analysis spanning 2010 to 2021 reveals a decrease of approximately 40% in underweight status among adults, while the proportion of malnourished patients younger than 18 years remained stable. Conversely, there was a substantial increase of over 70% in overweight status and over 85% in obesity among adults, with minor fluctuations observed among children and adolescents. Patient factors associated with increased obesity incidence included age older than 45 years, male gender, pancreatic sufficiency, possession of at least one CFTR variant conferring residual function, ppFEV1 > 90, and lower prevalence of Pseudomonas aeruginosa colonization. Conclusions: Our study confirms the evolving nutritional status landscape among Italian adult pwCF, with a significant shift towards overweight and obesity over the past decade. These trends highlight the need for proactive measures within CF standards of care to adapt and address the changing needs of patients.

[Italian Cystic Fibrosis Registry (ICFR). Report 2021-2022]. / Registro Italiano Fibrosi Cistica (RIFC). Rapporto 2021-2022.

INTRODUCTION: Italian Cystic Fibrosis Registry (ICFR) collects data of patients with cystic fibrosis (CF) through the collaboration with Italian CF referral and support Centres (Italian law 548/93). It aims at analysing medium and long-term clinical and epidemiological trends, identifying healthcare needs at regional and national levels, contributing to healthcare programmes, and resource allocation. Italian data are also compared at international level through the collaboration with the European CF Registry for sharing epidemiological data on general aspects like CF epidemiology and specific topics such as the use of CFTR modulators. OBJECTIVES: The purpose of this Report is to provide updated demographic and clinical data of the Italian FC population for the years 2021 and 2022, to contribute essential information for the implementation of projects aimed at improving the management of patients affected by this disease. DESIGN: Analyses and results presented in this Report pertain to patients currently under care at Italian National Referral and Support Centres for Cystic Fibrosis and Paediatric Hospital 'Bambino Gesù' in the 2021-2022 period. Data were submitted by clinical Centres through a dedicated web-based software and underwent dual quality control (QC) measures: automated quantitative QC within the software and secondary QC at the European level before the integration into the European Cystic Fibrosis Registry. These measures ensure data completeness, accuracy, and longitudinal consistency with European core data. SETTING AND PARTICIPANTS: A total of 27 CF Centres, including referral and support centres, as well as 'Bambino Gesù' Children's Hospital CF centre, submitted their data to ICFR for the years 2021-2022. Althourgh CF Centres in Verona and Messina do not use the ICFR software, their data are centrally collected and subsequently forwarded to the European Registry. Data from service centres in Treviso and Rovereto are transmitted via the Verona CF Centre. Data from Sardinia Centre are currently unavailable. RESULTS: The results section provides a comprehensive overview of various aspects of CF epidemiology and patient characteristics. 1.Demography: in 2021 and 2022, 5,977 and 6,077 CF patients were respectively included in the ICFR, with median ages of 23.3 and 23.7 years. The prevalence rates were 10.1 and 10.3 per 100,000 residents in Italy for the respective years, with males comprising 51.6% on average. The distribution by age showed a higher frequency among patients aged 7 to 35 years; adult patients constituted 63.5% on average in both years. 2. Diagnosis: most CF patients were diagnosed before the age of two (mean value 57.9%), with a significant percentage diagnosed in adult age (35.4% in 2021 and 25.6% in 2022). 3.New diagnoses: there were 113 new diagnoses in 2021 and 121 in 2022, with estimated incidences of 1 in 9,097 living births in 2021 and 1 in 6,232 in 2022. 4. Genetics: genetic analyses were conducted on 99.9% of patients, revealing CFTR gene mutations in over 98% of cases. The F508del mutation was the most common (44% of alleles in 2021), with 18% of patients having at least one "residual function" mutation. Gating mutations were present in 3.4% of Italian patients, while 20% had at least one-stop codon mutation. 5.Lung function: lung function, measured by percent predicted (pp)FEV1 (Forced Expiratory Volume in the first second) progressively declined before adulthood, with the majority of paediatric patients (92.8% in 2021 and 93.8% in 2022) maintaining a ppFEV1≥70%. 6.Nutrition: critical periods for nutrition were identified as the first 6 months of life and adolescence, with higher prevalence of malnourished male adolescents compared to females. Suboptimal BMI values were more common in adult females (28.7% in 2021 and 26.9% in 2022) compared to males (14.2% in 2021 and 12.6% in 2022). 7. Complications: CF-related liver disease without cirrhosis was prevalent in patients under 18 years (21.9% in 2021 and 21.2 in 2022), while CF-related diabetes was most frequent in adults (24.2%). 8.Transplantation: over the two-year period, 28 patients underwent double-lung transplantation, with median ages of 29.1 in 2021 and 35.3 in 2022, respectively. Median waiting times ranged from 9.4 to 11.6 months. 9.Microbiology: chronic Pseudomonas aeruginosa infection affected 37.2% of adult patients in 2021 and 36.0% in 2022, compared to 7.4% and 6.5% in paediatric patients. Staphylococcus aureus infection rates were 34.6% and 42.2% in 2021 among adults and 34.4% and 36.7% in 2022 among paediatric patients. 10. Mortality: a total of 34 patients died during the 2021-22 period (19 females, 15 males), with median ages at death of 43.7 years in 2021 and 46 years in 2022 (excluding transplanted patients). CONCLUSIONS: The present Report is an update of the data published in the past years and summarizes the main epidemiological and clinical data regarding Italian CF subjects in the years 2021 and 2022. The number of patients registered in 2021 was 5,977, while in 2022 was 6,077. The population coverage estimates for 2022 to be around 97%. In 2020, 60.5% of patients were older than 18 years, in 2022 adult patients account for 63.5% of the Italian CF population. Over the years, therefore, an increase in the median age of Italian CF patients has been observed, reaching 23.7 years in 2022. The absolute number of new diagnoses per year remains substantially unchanged over the years (a total of 234 in the period under review). The median age at diagnosis in 2022 was 2.5 months, 62.6% of subjects are really diagnosed within the first year of life and almost 90% of them are diagnosed through neonatal screening. In 2022, almost all patients underwent genetic analysis (99.9%). Data collected confirm the great variability among Italian CF patients. As regards respiratory function, what is reported in previous reports is here confirmed, with an ever-increasing percentage of subjects under the age of 18 having normal respiratory function, moreover, less than 1% of paediatric patients has a severe lung function (ppFEV1<40). The marked improvement in this indicator in the adult population seems to be mainly due to the introduction from 2021 in Italy of therapy with highly effective CFTR modulators. At the same time, the close positive correlation between nutritional status and respiratory function is confirmed for the adult population. As regards chronic infection by Pseudomonas aeruginosa, in 2022, a reduction in the percentage of chronic infection is observed both among adults (36% vs 38.8% in 2020) and in paediatric patients (6.5% vs 7.6% in 2020). The most frequent complication in both paediatric and adult populations is liver disease (respectively, in 24.2% and 41.3% of subjects). In the two-year period, 34 patients died; their median age at death was between 43 and 46 years (transplant patients excluded); only two patients under the age of 18 died in the period 2021 and 2022, confirming once again that mortality in paediatric age is a rare event. The data presented in this Report shows how the register can be a national and international point of reference for CF patients and the scientific community, a tool for describing the Italian CF population over the years, and a starting point for planning epidemiological studies and clinical studies.

Peritoneal Carcinomatosis of Malignant Gynecological Origin: A Systematic Review of Imaging Assessment.

This systematic review, conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol, aims to comprehensively assess the current state of the art of imaging modalities for the evaluation of peritoneal carcinomatosis arising from malignant gynecological origins, with a focus on ovarian and endometrial cancers. A systematic search of relevant databases was performed, adhering to predetermined inclusion and exclusion criteria. Studies reporting the use of computed tomography (CT), magnetic resonance imaging (MRI), fluorodeoxyglucose (FDG) positron emission tomography (PET), PET/CT, and PET/MRI in the assessment of peritoneal carcinomatosis from gynecological malignancies were included. The review encompasses an overview of selected studies, highlighting the strengths and limitations of each imaging modality in diagnosing and characterizing peritoneal carcinomatosis. Overall, a wide variability in the reported accuracy of different imaging techniques emerges from literature, mainly due to the type of the study, technical issues, and patient characteristics. Although a meta-analysis could not be performed due to a scarcity of data, this systematic review provides valuable insights into the several imaging approaches used in peritoneal carcinomatosis of gynecological origin. The findings aim to inform clinical decision making and guide future research endeavors in this critical aspect of gynecological oncology.

The new robotic system HUGO RAS for gynecologic surgery: First European experience from Gemelli Hospital.

OBJECTIVE: To evaluate the safety and feasibility of the new surgical robot HUGO robotic assisted surgery (RAS) in a series of gynecologic surgical procedures. METHODS: Between March and October 2022, 138 patients treated at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy were enrolled in the study. All patients suitable for a minimally-invasive approach were prospectively included and divided into two groups: Group 1 (78 patients) made up of patients operated on for uterine and/or adnexal pathologies, and Group 2 (60 patients) made up of patients treated for pelvic organ prolapse. RESULTS: In Group 1, median docking time (DT) was 5 min and median console time (CT) was 90 min. In two patients (2.6%) redocking was necessary. In two patients (2.6%), the surgeon continued the surgery laparoscopically. Intraoperative complications occurred in two surgeries (2.6%). In Group 2, median DT was 4 min and median CT was 134.5 min. In three patients (5%), redocking was necessary. In all patients, the surgery was successfully completed robotically without intraoperative complications. CONCLUSIONS: The present study demonstrates that the new HUGO RAS system for gynecologic surgery is safe with good results in terms of surgical efficacy and perioperative outcomes. Further studies are needed to investigate its use in other technical and surgical aspects.

Robotic docking time with the Hugo™ RAS system in gynecologic surgery: a procedure independent learning curve using the cumulative summation analysis (CUSUM).

Robot-assisted surgery has been proven to offer improvements in term of surgical learning curve and feasibility of minimally invasive surgery, but has often been criticized for its longer operative times compared to conventional laparoscopy. Additional times can be split into time required for system set-up, robotic arms docking and calibration of robotic instruments; secondly, surgeon's learning curve. One of the newest systems recently launched on the market is the Hugo™ RAS (MEDTRONIC Inc, United States). As some of the earliest adopters of the Hugo™ RAS system technology, we present our data on robotic docking learning curve for the first 192 gynecologic robotic cases performed at our institution. Our data indicates that robotic set-up and docking with the new Hugo™ RAS robotic surgical system can be performed time-effectively and that the specific robotic docking learning curve is comparable to preexisting data for other platforms. This preliminary insights into this recently released system may be worthwhile for other centers which may soon adopt this new technology and may need some relevant information on topics such as OR times. Further studies are necessary to assess the different features of the Hugo™ RAS considering other technical and surgical aspects, to fully become familiar with this novel technology.

How to combine CTA, 99mTc-WBC SPECT/CT, and [18F]FDG PET/CT in patients with suspected abdominal vascular endograft infections?

PURPOSE: We aimed at comparing 99mTc-HMPAO white blood cells (99mTc-WBC) scintigraphy, 18fluorine-fluorodeoxyglucose ([18F]FDG) positron emission tomography/computed tomography (PET/CT) and CT angiography (CTA) in patients with suspected abdominal vascular graft or endograft infection (VGEI). Moreover, we attempted to define a new visual score for interpreting [18F]FDG PET/CT scans aiming at increasing its specificity. METHODS: We prospectively compared 99mTc-WBC SPECT/CT, [18F]FDG PET/CT, and CTA in 26 patients with suspected abdominal VGEI. WBC scans were performed and interpreted according to EANM recommendations. [18F]FDG PET/CT studies were assessed with both qualitative (Sah's scale and new visual score) and semi-quantitative analyses. CTA images were interpreted according to MAGIC criteria. Microbiology, histopathology or a clinical follow-up of at least 24 months were used to achieve final diagnosis. RESULTS: Eleven out of 26 patients were infected. [18F]FDG PET/CT showed 100% sensitivity and NPV, with both scoring systems, thus representing an efficient tool to rule out the infection. The use of a more detailed scoring system provided statistically higher specificity compared to the previous Sah's scale (p = 0.049). 99mTc-WBC SPECT/CT provided statistically higher specificity and PPV than [18F]FDG PET/CT, regardless the interpretation criteria used and it can be, therefore, used in early post-surgical phases or to confirm or rule out a PET/CT finding. CONCLUSIONS: After CTA, patients with suspected late VGEI should perform a [18F]FDG PET/CT given its high sensitivity and NPV. However, given its lower specificity, positive results should be confirmed with 99mTc-WBC scintigraphy. The use of a more detailed scoring system reduces the number of 99mTc-WBC scans needed after [18F]FDG PET/CT. Nevertheless, in suspected infections within 4 months from surgery, 99mTc-WBC SPECT/CT should be performed as second exam, due to its high accuracy in differentiating sterile inflammation from infection.

Sacrocolpopexy after sub-total hysterectomy vs. sacral hysteropexy for advanced urogenital prolapse: A propensity-matched study.

OBJECTIVE: To compare objective and subjective outcomes of laparoscopic sacral colpopexy with supracervical hysterectomy (L-SCP) and robotic sacral hysteropexy (R-SHP). METHODS: This is a multicenter retrospective propensity score matched study. In the period between January 2014 and December 2018, we enrolled 161 patients with apical prolapse stage 2 or above, alone or with multicompartment descensus. RESULTS: After propensity-match analysis, there were 44 women for each group. Patients of the two groups had similar preoperative characteristics. No difference was found in terms of estimated blood loss, hospital stay, operative time, and intraoperative or postoperative complications. Subjective success rate, 12 months after surgery, was statistically better in the L-SCP group (P = 0.034): 81.8% and 97.8% women had Patient Global Impression of Improvement scores less than 3, in R-SHP and L-SCP, respectively. The objective cure rate was high in both groups without any significant differences in recurrence rate (P = 0.266). CONCLUSION: Both procedures are safe and effective in pelvic organ prolapse treatment. Patients who no longer desire uterine preservation could be encouraged to consider L-SCP. R-SHP is an alternative in women who are strongly motivated to preserve their uterus in the absence of abnormal uterine findings.

Predictive Role of Serum Thyroglobulin after Surgery and before Radioactive Iodine Therapy in Patients with Thyroid Carcinoma.

INTRODUCTION: Thyroidectomy followed by radioactive iodine therapy (RAI) is the treatment of choice for differentiated thyroid carcinoma (DTC). Serum thyroglobulin (Tg) measurement has proved to be useful for predicting persistent and/or recurrent disease during follow-up of DTC patients. In our study, we evaluated the risk of disease recurrence in patients with papillary thyroid carcinoma (PTC), who were treated with thyroidectomy and RAI, by measuring serum Tg at different time-points: at least 40 days after surgery, in euthyroidism with TSH < 1.5 and usually 30 days before RAI (Tg-30), on the day of RAI (Tg0), and seven days after RAI (Tg+7). METHODS: One hundred and twenty-nine patients with PTC were enrolled in this retrospective study. All patients were treated with 131I for thyroid remnant ablation. Disease relapse (nodal disease or distant disease) during at least 36 months follow-up was evaluated by serum measurements of Tg, TSH, AbTg at different time points and by imaging techniques (neck ultrasonography, 131I-whole body scan (WBS) after Thyrogen® stimulation). Typically, patients were assessed at 3, 6, 12, 18, 24, and 36 months after RAI. We classified patients in five groups: (i) those who developed nodal disease (ND), (ii) those who developed distant disease (DD), (iii) those with biochemical indeterminate response and minimal residual thyroid tissue (R), (iv) those with no evidence of structural or biochemical disease + intermediate ATA risk (NED-I), and (v) those with no evidence of structural or biochemical disease + low ATA risk (NED-L). ROC curves for Tg were generated to find potential discriminating cutoffs of Tg values in all patients' groups. RESULTS: A total of 15 out of 129 patients (11.63%) developed nodal disease and 5 (3.88%) distant metastases, during the follow-up. We found that Tg-30 (with suppressed TSH) has the same sensitivity and specificity than Tg0 (with stimulated TSH), and it is slightly better than Tg+7, which can be influenced by the size of the residual thyroid tissue. CONCLUSION: Serum Tg-30 value, measured in euthyroidism 30 days before RAI, is a reliable prognostic factor to predict future nodal or distant disease, thus allowing to plan the most appropriate therapy and follow-up.

A Systematic Review on Combined [18F]FDG and 68Ga-SSA PET/CT in Pulmonary Carcinoid.

Pulmonary carcinoids (PCs) are part of a spectrum of well-differentiated neuroendocrine neoplasms (NENs) and are classified as typical carcinoid (TC) and atypical carcinoid (AC). TC differ from AC not only for its histopathological features but also for its "functional imaging pattern" and prognosis. ACs are more undifferentiated and characterized by higher aggressiveness. Positron emission tomography/computed tomography (PET/CT) with somatostatin analogs (SSA) labeled with Gallium-68 (68Ga-DOTA-TOC, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE) has widely replaced conventional imaging with gamma camera using 111In- or 99mTc-labelled compounds and represents now the gold standard for diagnosis and management of NENs. In this setting, as already described for gastro-entero-pancreatic NENs, 18F-Fluorodeoxiglucose ([18F]FDG) in addition to 68Ga-SSA can play an important role in clinical practice, particularly for ACs that show a more aggressive behavior compared to TCs. The aim of this systematic review is to analyze all original studies collected from the PubMed and Scopus databases regarding PCs in which both 68Ga-SSA PET/CT and [18F]FDG PET/CT were performed in order to evaluate the clinical impact of each imaging modality. The following keywords were used for the research: "18F, 68Ga and (bronchial carcinoid or carcinoid lung)". A total of 57 papers were found, of which 17 were duplicates, 8 were reviews, 10 were case reports, and 1 was an editorial. Of the remaining 21 papers, 12 were ineligible because they did not focus on PC or did not compare 68Ga-SSA and [18F]FDG. We finally retrieved and analyzed nine papers (245 patients with TCs and 110 patients with ACs), and the results highlight the importance of the combined use of 68Ga-SSA and [18F]FDG PET/CT for the correct management of these neoplasms.

The first 60 cases of robotic sacrocolpopexy with the novel HUGO RAS system: feasibility, setting and perioperative outcomes.

Introduction: We present the preliminary report of the first 60 cases of robotic sacrocolpopexy (RSCP) performed with a minimally invasive approach by using the new HUGO RAS system (Medtronic) with the aim of assessing its feasibility, safety and efficacy. Methods: Results in terms of operative time, intraoperative blood loss, post-operative pain, length of hospitalisation, intra and post-operative complications were comparable to previously described laparoscopic and robotic techniques. Results: Urogynecological assessment at three months follow up showed surgical anatomic success in 96.7% of patients (<2 POP-Q stage), while subjective cure rate was 98.3%. Conclusions: This is the first series analyzing RSCP outcomes for POP using the new Hugo RAS system. Our results suggest effectiveness both in objective and subjective outcomes, with minimal intra and post-operative complications. Larger series as well as longer follow-up are needed to better define advantages and possible disadvantages of this novel system. Our work may represent the basis of future studies to confirm its safety, efficacy and feasibility, and may provide technical notes for other centres that wish to perform RSCP through this innovative system.

Robot-assisted pelvic floor reconstructive surgery: an international Delphi study of expert users.

BACKGROUND: Robotic surgery has gained popularity for the reconstruction of pelvic floor defects. Nonetheless, there is no evidence that robot-assisted reconstructive surgery is either appropriate or superior to standard laparoscopy for the performance of pelvic floor reconstructive procedures or that it is sustainable. The aim of this project was to address the proper role of robotic pelvic floor reconstructive procedures using expert opinion. METHODS: We set up an international, multidisciplinary group of 26 experts to participate in a Delphi process on robotics as applied to pelvic floor reconstructive surgery. The group comprised urogynecologists, urologists, and colorectal surgeons with long-term experience in the performance of pelvic floor reconstructive procedures and with the use of the robot, who were identified primarily based on peer-reviewed publications. Two rounds of the Delphi process were conducted. The first included 63 statements pertaining to surgeons' characteristics, general questions, indications, surgical technique, and future-oriented questions. A second round including 20 statements was used to reassess those statements where borderline agreement was obtained during the first round. The final step consisted of a face-to-face meeting with all participants to present and discuss the results of the analysis. RESULTS: The 26 experts agreed that robotics is a suitable indication for pelvic floor reconstructive surgery because of the significant technical advantages that it confers relative to standard laparoscopy. Experts considered these advantages particularly important for the execution of complex reconstructive procedures, although the benefits can be found also during less challenging cases. The experts considered the robot safe and effective for pelvic floor reconstruction and generally thought that the additional costs are offset by the increased surgical efficacy. CONCLUSION: Robotics is a suitable choice for pelvic reconstruction, but this Delphi initiative calls for more research to objectively assess the specific settings where robotic surgery would provide the most benefit.

Radioimmune Imaging of α4ß7 Integrin and TNFα for Diagnostic and Therapeutic Applications in Inflammatory Bowel Disease.

Imaging using radiolabelled monoclonal antibodies can provide, non-invasively, molecular information which allows for the planning of the best treatment and for monitoring the therapeutic response in cancer, as well as in chronic inflammatory diseases. In the present study, our main goal was to evaluate if a pre-therapy scan with radiolabelled anti-α4ß7 integrin or radiolabelled anti-TNFα mAb could predict therapeutic outcome with unlabelled anti-α4ß7 integrin or anti-TNFα mAb. To this aim, we developed two radiopharmaceuticals to study the expression of therapeutic targets for inflammatory bowel diseases (IBD), to be used for therapy decision making. Both anti-α4ß7 integrin and anti-TNFα mAbs were successfully radiolabelled with technetium-99m with high labelling efficiency and stability. Dextran sulfate sodium (DSS)-induced colitis was used as a model for murine IBD and the bowel uptake of radiolabelled mAbs was evaluated ex vivo and in vivo by planar and SPECT/CT images. These studies allowed us to define best imaging strategy and to validate the specificity of mAb binding in vivo to their targets. Bowel uptake in four different regions was compared to immunohistochemistry (IHC) score (partial and global). Then, to evaluate the biomarker expression prior to therapy administration, in initial IBD, another group of DSS-treated mice was injected with radiolabelled mAb on day 2 of DSS administration (to quantify the presence of the target in the bowel) and then injected with a single therapeutic dose of unlabelled anti-α4ß7 integrin or anti-TNFα mAb. Good correlation was demonstrated between bowel uptake of radiolabelled mAb and immunohistochemistry (IHC) score, both in vivo and ex vivo. Mice treated with unlabelled α4ß7 integrin and anti-TNFα showed an inverse correlation between the bowel uptake of radiolabelled mAb and the histological score after therapy, proving that only mice with high α4ß7 integrin or TNFα expression will benefit of therapy with unlabelled mAb.

[18F]FDG Uptake in Non-Infected Endovascular Grafts: A Retrospective Study.

Purpose: After endovascular aneurysm repair (EVAR), an increased [18F]FDG uptake may be observed at PET/CT, being common to both vascular graft/endograft infection (VGEI) and sterile post-surgical inflammation. Increased non-specific metabolic activity, due to foreign body reaction, can persist for several years after surgery, thus complicating the interpretation of PET/CT studies. In this paper, we aimed to assess [18F]FDG distribution at different time-points after the implant of abdominal Endurant® endografts in patients without suspicion of infection. Methods: We retrospectively evaluated [18F]FDG/CT in 16 oncological patients who underwent abdominal aortic aneurysm exclusion with Endurant® grafts. Patients had no clinical suspicion of infection and were followed up for at least 24 months after scan. [18F]FDG PET/CT scans were interpreted using both visual and semi-quantitative analyses. Results: The time between the EVAR procedure and [18F]FDG PET/CT ranged between 1 and 36 months. All grafts showed mild and diffuse [18F]FDG uptake without a focal pattern. Mean values of SUVmax were 2.63 ± 0.48 (95% CI 2.38-2.88); for SUVmean 1.90 ± 0.33 (95% CI 1.72-2.08); for T/B ratios 1.43 ± 0.41 (95% CI 1.21-1.65). SUVmax and SUVmean were not correlated to the time elapsed from the procedure, but we observed a declining trend in T/B ratio over time. Conclusions: Endovascular implant of Endurant® grafts does not cause a significant inflammatory reaction. The evidence of faint and diffuse [18F]FDG uptake along the graft can reliably exclude an infection, even in early post-procedural phases. Therefore, in patients with a low probability of VGEI, [18F]FDG PET/CT can also be performed immediately after EVAR.

Laparoscopic posterior vaginal plication plus sacral colpopexy for severe posterior vaginal prolapse: A randomized clinical trial.

AIM: A randomized clinical trial proposing a new laparoscopic prosthetic and fascial approach to severe posterior vaginal prolapse. The primary endpoint was to evaluate the objective and subjective outcomes of our laparoscopic posterior plication (LPP) combined to "two-mesh" sacral colpopexy (laparoscopic sacral colpopexy [LSC]) in severe posterior vaginal prolapse, with a 1-year follow-up. The secondary endpoint was to evaluate the safety of this surgical procedure. METHODS: This is single-center prospective randomized double-blinded clinical trial. A total of 130 consecutive patients with anterior and/or apical pelvic organ prolapse (POP) (POP-Q stage ≥II) and severe posterior vaginal prolapse (posterior POP-Q stage ≥III) were prospectively assessed for inclusion into the study from November 2018 to January 2020. Patients underwent "two-meshes" LSC and were randomized in Group A (LSC plus LPP) and Group A (LSC alone). Of the 130 included subjects, 8 were excluded, not meeting inclusion criteria. Cure rate was evaluated objectively, using POP-Q study, and subjectively using PGI-I, POPDI-6, and FSDS questionnaires. Complications were assessed intra-, peri-, and postoperatively. Twelve-month follow-ups were analyzed for the study. RESULTS: We found in LSC plus LPP Group a significant improvement of Ap and genital hiatus POP-Q points. Our subjective study showed, at 12 months, a statistical difference in PGI-I successful outcomes rate in favor of LPP. Also the FSDS resulted significantly much more improved in Group A. We observed no statistical differences in terms of postoperative complications. CONCLUSIONS: Our LPP approach to LSC could be considered an effective and safe technique to POP patients with severe posterior prolapse.

Is There a Role for Bladder Biopsy in the Diagnosis of Non-Hunner Lesions Interstitial Cystitis?

INTRODUCTION: Bladder pain syndrome/interstitial cystitis (BPS/IC) is either Hunner lesion interstitial cystitis (HL IC) or non-Hunner lesion interstitial cystitis (N-HL IC), differing in the presence of HLs on cystoscopy. Cystoscopy is essential in diagnosing HL but are bladder biopsies useful in N-HL IC patients? Our objective was to assess bladder biopsy in patients with N-HL IC, evaluating whether the count of mast cells (MCs) and percentage of activated MCs could measure severity. MATERIALS AND METHODS: This is a single-centre retrospective study. INCLUSION CRITERIA: diagnosis of BPS/IC by ESSIC definition; absence of HLs. Each patient had three bladder biopsies. STATISTICAL ANALYSIS: χ2/Fischer's exact test; Wilcoxon signed-ranks test/Mann-Whitney U test. Statistical significance: p < 0.05. RESULTS: We separated 48 women into Group 1 with <50% of MCs activated and Group 2 with >50%. We compared the results of the O'Leary-Sant questionnaire between the two groups and did not find any correlation between the severity of the pathology and either the MC count in the detrusor or the percentage of activated MCs in the lamina propria or detrusor. DISCUSSION/CONCLUSION: These findings cast doubt on the usefulness of bladder biopsy for the evaluation of severity in N-HL IC.

OCT angiography indices and the choroidal vascularity index in wild-type transthyretin (TTR) amyloidosis (ATTRwt).

Purpose: Retinal angiopathy represents a well-known ocular manifestation of hereditary transthyretin amyloidosis (ATTRv). Until recently, there have been no reports on retinal changes in ATTRwt. In this retrospective observational clinical study, we aimed to determine whether vessel density (VD) indices and the choroidal vascularity index (CVI) could offer insights into retinal and choroidal vascular changes among patients affected by ATTRwt. Methods: Eighteen patients with a confirmed diagnosis of ATTRwt underwent structural optical coherence tomography (OCT) and OCT angiography (OCTA). We established a control group consisting of 16 healthy subjects for statistical comparisons. The 3D OCT and OCTA datasets were analyzed to assess retinal and choroidal thickness and VD. For measuring CVI, we obtained measurements for the total choroid area (TCA), luminal area (LA), and stromal area (SA). Results: The mean VD exhibited a statistically significant reduction in the superficial capillary plexus (SCP), deep capillary plexus (DCP), and choriocapillaris (CC) among the ATTRwt group in comparison to the control group (p < 0.0001). Notably, ATTRwt patients displayed decreased choroidal thickness (p = 0.08). Additionally, the median CVI was lower in the ATTRwt group than in the control group (p = 0.04). Conclusion: The indices from OCTA and CVI have the potential to serve as non-invasive biomarkers for the quantitative evaluation of retinal and choroidal vascular involvement in patients with ATTRwt.

[Italian Cystic Fibrosis Registry (ICFR). Report 2019-2020]. / Registro italiano Fibrosi Cistica (RIFC). Rapporto 2019-2020.

INTRODUCTION: Italian cystic fibrosis registry (ICFR) collects data from cystic fibrosis (CF) patients through the collaboration with Italian CF referral and support Centres (Italian law 548/93). ICFR contributes: • to the analysis of medium and long term clinical and epidemiological trends of the disease; • to the identification of the main health care needs at regional and national level to contribute to the Health Care programmes and to the distribution of resources; • to the comparison of the Italian data with international ones. This latter is based on the collaboration with the European CF registry and, due the COVID-19 pandemic emergency, with important global projects. OBJECTIVES: The purpose of this Report is to update the demographic and clinical data of the Italian FC population in the years 2019 and 2020, contributing to the information necessary to implement projects to improve the management of patients affected by this disease. DESIGN: Analyses and results described in the present Report are referred to patients currently followed at the Italian National Referral and Support Centres for Cystic Fibrosis in the 2019-2020 period. Data were sent by clinical Centres through a dedicated web-based software. Data undergo a double quality control (QC): the first is automatically performed by the software (quantitative QC), the second is performed at a European level (before the inclusion of the Italian data within the European Cystic Fibrosis Registry). These QCs assure the completeness and the accuracy of data as well as their longitudinal consistency with the European core data. SETTING AND PARTICIPANTS: A total of 29 CF Centres (referral and support centres and 'Bambino Gesù' Children's Hospital CF centre) sent to ICFR their data referred referred to years 2019-2020. CF Centres of Verona, Messina, and Palermo (this latter only for 2019) do not use the ICFR software; however, their data are firstly collected in a centralized manner, then sent to the European Registry. Data from support centres of Treviso and Rovereto are sent through the Verona CF Center. Finally, data from Sardinia Centre are still missing. RESULTS: The present Report has been organized into 10 sections. 1. Demography: in 2019, 5,585 CF patients were registered in the ICFR and 5,801 in 2020; median age was 21.6 years in 2019 and 22.4 years in 2020. Prevalence was 9.36/100,000 and 9.79/100,000 residents in Italy in 2019 and in 2020, respectively. Male percentage was 51.5% in 2019 and 2020 and CF distribution by age range showed higher frequency in patients aged 7 to 35 years. Adult patients (aged more than 18 years) were 59.5% on average in both years. 2. Diagnoses: most of the CF patients were diagnosed before two years of age (median value 68.5%); a significant percentage of patients (12.9% in 2019 and 13.4% in 2020) was diagnosed in adult age. 3. New diagnoses: new diagnoses were 136 in 2019 and 96 in 2020. Estimated incidence was 1/5.568 living births in 2019 and 1/7.369 in 2020. 4. Genetics: 99.9% of patients underwent genetic analyses and in 98.2% of these patients a mutation in Cystic Fibrosis Transmembrane Regulator (CFTR) gene was identified. The F508del mutation was the most frequent (identified in 44.7% allele; 2019 data). Furthermore, on average 17.3% of patients had at least one 'residual function' mutation. At least one gating mutation is present in 3.3% of Italian patients. Finally, 20.5% of patients had at least one stop codon mutation (class 1). 5. Lung function: percent predicted FEV1 (Forced Expiratory Volume in the first second) progressively declined before adult age, in accordance with the natural history of the disease. The majority of paediatric patients (6-17 years of age), i.e., 86.7% in 2019 and 90.5% in 2020, had percent predicted FEV1 >=70%; whereas paediatric patients with a FEV1% >=40% are less than 2% in the study period. 6. Nutrition: the two most critical periods are the first 6 months of life and adolescence. Prevalence of malnourished adolescent males (12-17 years of age) is higher than the prevalence observed in females. Increasing percentages of female patients with a suboptimal BMI value (33.5% and 31.4%, respectively, in 2019 and 2020) are observed in adult age. 7. Complications: in 2019, CF-related liver disease without cirrhosis was the main complication both in patients aged less than 18 years (20.3% on average) and in adults (37.5%). CF-related diabetes was also frequent in CF adults (23.4%). 8. Transplantation: in 2019-2020, 64 patients received a double-lung transplantation. Median and range of age were 33 years (12.29-57.46) in 2017 and 32.9 (16.5-53.6) years in 2020. Median waiting times for lung transplantation in the two-year period ranged from 6 to 8 months. 9. Microbiology: percentage of adult patients with chronic Pseudomonas aeruginosa infection was 41.6% in 2019 and 38.8% in 2020 vs 14.3% in 2019 and 7.6% in 2020 in paediatric age. Staphylococcus aureus infection is present in 31.1% and 35.9% of adult patients in 2019 and in 33.5% and 34.7% of paediatric patients in 2020. 10. Mortality: a total of 51 patients died in the 2019-2020 period (28 females and 23 males); median age at death was 35.7 years in 2019 and 39 years in 2020 (transplanted patients are not included). CONCLUSIONS: The present report shows that the Italian CF population is growing (4,159 in 2010 vs 5,801 in 2020). Median age of patients increased in the 2010-2020 period (17 years in 2010 vs 22.4 years in 2020). Prevalence of adult patients is increasing (in 2020, 60.5% of patients is more than 18 years old). About 68.5% of new patients is diagnosed within the second year of life and median age at death (transplanted patients not included) increased in 2020 up to 39 years (in 2018 this value was 35.8). Some statistical differences between 2019 and 2020 are mainly due to the absence of about 200 patients not included in 2019 data by a participating centre for a technical problem.

Laparoscopic uterosacral ligament suspension: a comprehensive, systematic literature review.

OBJECTIVES: Laparoscopic uterosacral ligament suspension (LUSLS) of the vaginal apex for the treatment of pelvic organ prolapse (POP) has gained popularity. The aim of this systematic review is to investigate perioperative outcomes and complications, subjective and objective success rates and recurrence rates in women undergoing this surgical procedure. STUDY DESIGN: A systematic literature search was performed in December 2021. The critical appraisal skills program (CASP) was used to assess the methodological quality of the selected studies. The Clavien-Dindo (CD) scale and the Satava scale were used to classify periprocedural complications. Continuous variables were described as means and standard deviations while categorical were expressed as percentages of the whole group. Statistical significance was set at p < 0.05. RESULTS: 26 articles were selected and analysed, with a total population of 1401 patients. Anatomical and subjective success rates after LUSLS ranged from 79% and 100% and from 76.2% to 100% respectively. The re-operation rate varied from 2% to 4.5% in the largest cohorts. The overall complication rate was 13.6%, however grade III CD complications occurred only in 1% of patients. Ureteral complications were described in only 2 cases. CONCLUSIONS: LUSLS represent a safe and effective technique for vaginal apex resuspension in women with POP. Further larger prospective randomized studies are required to confirm these data.