Methodological rigour in preclinical urology: a systematic review reporting research quality over a 14-year period.

OBJECTIVE: To investigate the prevalence and trends of essential study design elements in preclinical urological studies, as well as key factors that may improve methodological rigour, as the demand for methodological rigour in preclinical studies is increasing since research reproducibility and transparency in the medico-scientific field are being questioned. METHODS AND RESULTS: PubMed was searched to include preclinical urological studies published between July 2007 to June 2021. A total of 3768 articles met the inclusion criteria. Data on study design elements and animal models used were collected. Citation density was also examined as a surrogate marker of study influence. We performed an analysis of the prevalence of seven critical study design elements and temporal patterns over 14 years. Randomisation was reported in 50.0%, blinding in 15.0%, sample size estimation in 1.0%, inclusion of both sexes in 6.3%, statistical analysis in 97.1%, housing and husbandry in 47.7%, and inclusion/exclusion criteria in 5.0%. Temporal analysis showed that the implementation of these study design elements has increased, except for inclusion of both sexes and inclusion/exclusion criteria. Reporting study design elements were associated with increased citation density in randomisation and statistical analysis. CONCLUSIONS: The risk of bias is prevalent in 14-year publications describing preclinical urological research, and the quality of methodological rigour is barely related to the citation density of the article. Yet five study design elements (randomisation, blinding, sample size estimation, statistical analysis, and housing and husbandry) proposed by both the National Institutes of Health and Animal Research: Reporting of In Vivo Experiments guidelines have been either well reported or are being well reported over time. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022233125.

Clinical and economic impact of the introduction of pre-biopsy MRI-based assessment on a large prostate cancer centre diagnostic population and activity: 10 years on.

INTRODUCTION: Prostate mpMRI was introduced in 2011 as a secondary test and subsequently integrated into a prostate cancer (PCa) diagnostics unit representing a population of approximately 550,000 people. The following represents an audit of its step-wise introduction between 2 index years, 2009 and 2018, focusing on the activity, patient outcomes and economic benefits. PATIENTS AND METHODS: The 2 distinct years were selected for relying on a transrectal ultrasound biopsy pathway in 2009 to an mpMRI-based pathway in 2018. All referrals were retrospectively screened and compared for age, PSA levels, DRE findings, biopsy history, biopsy and mpMRI allocation data. Cost analysis was determined using local unit procedure costs. RESULTS: Patients referred included 648 in 2009 and 714 in 2018. mpMRI seldomly informed decision to biopsy in 2009 (9.8%), while in 2018 it was performed in the pre-biopsy setting in 87.9% cases and enabled biopsy avoidance in 137 patients. In 2018, there was a 31.8% decrease in the number of biopsies in patients without previous PCa diagnosis, coupled with an increase in diagnostic rates of csPCa, from 28.6 to 49.0% (p < 0.0001) and a reduction in negative biopsy rates from 52.3 to 33.8%. mpMRI had a positive impact on the system with reduced patient morbidity and post-procedural complications. The estimated overall cost savings amount to approximately £75,000/year for PCa diagnosis and £11,000/year due to reduced complications. CONCLUSION: Our evaluation shows the mpMRI-based pathway has improved early detection of csPCa and reduction of repeat biopsies, resulting in significant financial benefits for the local healthcare system.

The impact of urinary incontinence on multiple health outcomes: an umbrella review of meta-analysis of observational studies.

BACKGROUND AND AIM: We aimed to capture the breadth of health outcomes that have been associated with the presence of Urinary Incontinence (UI) and systematically assess the quality, strength, and credibility of these associations through an umbrella review and integrated meta-analyses. METHODS: We assessed meta-analyses of observational studies based on random-effect summary effect sizes and their p-values, 95% prediction intervals, heterogeneity, small-study effects, and excess significance. We graded the evidence from convincing (Class I) to weak (Class IV). RESULTS AND DISCUSSION: From 3172 articles returned in search of the literature, 9 systematic reviews were included with a total of 41 outcomes. Overall, 37 out of the 41 outcomes reported nominally significant summary results (p < 0.05), with 22 associations surviving the application of a more stringent p-value (p < 10-6). UI was associated with worse scores than controls in female sexual function (Class II), while it was also associated with a higher prevalence of depression (odds ratio [OR] = 1.815; 95% confidence interval [CI]: 1.551-2.124), and anxiety (OR = 1.498; 95% CI: 1.273-1.762) (Class IV). UI was associated with poorer quality of life (QoL), higher rate of mortality (hazard ratio = 2.392; 95% CI: 2.053-2.787) an increase in falls, frailty, pressure ulcers, diabetes, arthritis, and fecal incontinence (Class IV). CONCLUSIONS: UI is associated with female sexual dysfunction, with highly suggestive evidence. However, the evidence of other adverse outcomes including depression, anxiety, poorer QoL, higher mortality, falls, pressure ulcers, diabetes, arthritis, fecal incontinence, and frailty is only weak. A multidimensional approach should be taken in managing UI in the clinical setting.

Physical multimorbidity and incident urinary incontinence among community-dwelling adults aged ≥50 years: findings from a prospective analysis of the Irish Longitudinal Study on Ageing.

BACKGROUND: There are no prospective studies on the association between multimorbidity and urinary incontinence (UI), while mediators in this association are unknown. Thus, we aimed to (i) investigate the longitudinal association between multimorbidity and UI in a large sample of Irish adults aged ≥50 years and (ii) investigate to what extent physical activity, polypharmacy, cognitive function, sleep problems, handgrip strength and disability mediate the association. METHODS: Data on 5,946 adults aged ≥50 years old from the Irish Longitudinal Study on Aging were analysed. The baseline survey was conducted between 2009 and 2011 and follow-up after 2 years was conducted. Information on self-reported occurrence of UI in the past 12 months and lifetime diagnosis of 14 chronic conditions were obtained. Multivariable logistic regression and mediation analysis were conducted. RESULTS: After adjustment for potential confounders, compared to having no chronic conditions at baseline, having three (odds ratio [OR] = 1.79; 95% confidence interval [CI] = 1.30-2.48) and four or more (OR = 1.86; 95% CI = 1.32-2.60), chronic conditions were significantly associated with incident UI. Mediation analysis showed that polypharmacy, sleep problems and disability explained 22.7, 17.8 and 14.7% of the association between multimorbidity (i.e. two or more chronic conditions) and incident UI, respectively. CONCLUSION: A greater number of chronic conditions at baseline were associated with a higher risk for incident UI at 2-year follow-up among adults aged ≥50 years in Ireland. Considering the effects of different medications on UI and improving sleep quality and disability among people aged ≥50 years with multimorbidity may reduce the incidence of UI.

Introducing WASHOUT: A Large-scale Observational Study of Inpatient Haematuria.

WASHOUT is an international, multicentre, prospective observational study aiming to describe the management of unscheduled haematuria admissions. Preregistration can be done using the following link: https://redcap.link/WASHOUT.

Machine Learning and External Validation of the IDENTIFY Risk Calculator for Patients with Haematuria Referred to Secondary Care for Suspected Urinary Tract Cancer.

BACKGROUND: The IDENTIFY study developed a model to predict urinary tract cancer using patient characteristics from a large multicentre, international cohort of patients referred with haematuria. In addition to calculating an individual's cancer risk, it proposes thresholds to stratify them into very-low-risk (<1%), low-risk (1-<5%), intermediate-risk (5-<20%), and high-risk (≥20%) groups. OBJECTIVE: To externally validate the IDENTIFY haematuria risk calculator and compare traditional regression with machine learning algorithms. DESIGN, SETTING, AND PARTICIPANTS: Prospective data were collected on patients referred to secondary care with new haematuria. Data were collected for patient variables included in the IDENTIFY risk calculator, cancer outcome, and TNM staging. Machine learning methods were used to evaluate whether better models than those developed with traditional regression methods existed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The area under the receiver operating characteristic curve (AUC) for the detection of urinary tract cancer, calibration coefficient, calibration in the large (CITL), and Brier score were determined. RESULTS AND LIMITATIONS: There were 3582 patients in the validation cohort. The development and validation cohorts were well matched. The AUC of the IDENTIFY risk calculator on the validation cohort was 0.78. This improved to 0.80 on a subanalysis of urothelial cancer prevalent countries alone, with a calibration slope of 1.04, CITL of 0.24, and Brier score of 0.14. The best machine learning model was Random Forest, which achieved an AUC of 0.76 on the validation cohort. There were no cancers stratified to the very-low-risk group in the validation cohort. Most cancers were stratified to the intermediate- and high-risk groups, with more aggressive cancers in higher-risk groups. CONCLUSIONS: The IDENTIFY risk calculator performed well at predicting cancer in patients referred with haematuria on external validation. This tool can be used by urologists to better counsel patients on their cancer risks, to prioritise diagnostic resources on appropriate patients, and to avoid unnecessary invasive procedures in those with a very low risk of cancer. PATIENT SUMMARY: We previously developed a calculator that predicts patients' risk of cancer when they have blood in their urine, based on their personal characteristics. We have validated this risk calculator, by testing it on a separate group of patients to ensure that it works as expected. Most patients found to have cancer tended to be in the higher-risk groups and had more aggressive types of cancer with a higher risk. This tool can be used by clinicians to fast-track high-risk patients based on the calculator and investigate them more thoroughly.

Transurethral resection of bladder tumour (TURBT) as a day-case: A real-world practice and patients' perspective from a district general hospital (DGH).

INTRODUCTION: Day-case transurethral resection of bladder tumour (TURBT) is currently only performed in 18% cases across the United Kingdom. To determine 30-day readmission rate and morbidity after day-case TURBT in a district general hospital (DGH) and to report patient demographics, quality of TURBT and early recurrence rate as well as patient feedback after day-case TURBT. METHODS: A retrospective audit of day-case TURBTs over a 3-year pre-COVID19 (2017-20) was performed. We only included patients who underwent a TURBT and excluded any cystoscopy and biopsy or fulguration. A day-case TURBT pathway is in place in this centre. Feedback was obtained using hospital patient feedback forms. RESULTS: We included 77 patients who underwent TURBT in the day-case theatre, of these 5 patients required in-patient stay after the surgery. Of the remaining 72 discharged on the same day, 8 were re-admitted (11%) for Clavien-Dindo I complications. The readmission/failed discharge group had a higher rate of older patients, with higher ASA scores and longer operative times, however resection quality and tumour characteristics were not different from the day-case TURBTs. All patients reported an overall positive experience (good or very good). CONCLUSIONS: In the first of its kind audit reporting patient feedback after day-case TURBT, the data obtained can provide us and other centres adopting day-case TURBTs guidance to employ better patient selection to reduce readmission rates. Hence, day-case TURBT can be a feasible option in appropriately selected patients, with a suitable pathway in place.

The ARTS (Avoiding Risks of Thrombosis and Bleeding in Surgery) Trial: Lessons Learnt in Setting Up an International Multicentre Clinical Trial of an Investigational Medicinal Product in the UK.

We describe our experience in setting up the UK arm of the ARTS trial and highlight regulatory and funding challenges in relation to an international multicentre setting for an investigational medicinal product.

Vector Prostate Biopsy: A Novel Magnetic Resonance Imaging/Ultrasound Image Fusion Transperineal Biopsy Technique Using Electromagnetic Needle Tracking Under Local Anaesthesia.

BACKGROUND: Prostate magnetic resonance imaging (MRI) is now standard for assessment of suspected prostate cancer (PCa). A variety of approaches to MRI-based targeting has revolutionised prostate biopsies. OBJECTIVE: To describe the procedure and show the accuracy and tolerability of a novel Vector MRI/ultrasound fusion transperineal (TP) biopsy technique that uses electromagnetic (EM) needle tracking under local anaesthesia (LA). DESIGN, SETTING, AND PARTICIPANTS: Vector prostate biopsy using BiopSee fusion software, EM tracking technology, and transrectal ultrasound was performed in 69 patients meeting the biopsy criteria in two UK centres between September 2020 and August 2022. SURGICAL PROCEDURE: Stepper-mounted rectal ultrasound images were fused with MRI scans. LA was applied into two defined perineal tracks and a needle sheath with an EM sensor was inserted. The biopsy needle was directed precisely through the sheath to MRI targets under EM tracking. Biopsies were taken without antibiotic prophylaxis. MEASUREMENTS: Cancer detection (any PCa; grade group ≥2), side effects, and patient experience measures were recorded. RESULTS AND LIMITATIONS: Cancer detection in patients with Likert 4-5 lesions was 98% for any PCa and 83% for grade group ≥2. According to the 50 questionnaires returned, 42 patients (84%) reported no or minimal pain, while 40 (80%) reported no or minimal discomfort. No episodes of postoperative urinary retention occurred, and only one patient required treatment for infection. Limitations include the low patient number and incomplete responses to questionnaires. CONCLUSIONS: This novel Vector technique provides a feasible and tolerable procedure for MRI/ultrasound fusion TP biopsy under LA, with high cancer detection rates. This is achieved while maintaining patient comfort and with minimal rates of complications. PATIENT SUMMARY: We report a novel technique that uses electromagnetic needle tracking to perform highly accurate and comfortable prostate biopsies through the perineum under local anaesthetic.

Natural History of Patients with Prostate MRI Likert 1-3 and Development of RosCaP: a Multivariate Risk Score for Clinically Significant Cancer.

INTRODUCTION: Clinically significant prostate cancer (csCaP) with Gleason ≥3 + 4 is found in 10% negative prebiopsy multiparametric (mp) MRI cases and varies widely for equivocal mpMRI cases. The objective of this study was to investigate long-term outcomes of patients with negative and equivocal mpMRIs and to develop a predictive score for csCaP risk stratification in this group. PATIENTS AND METHODS: Patients who underwent an upfront mpMRI between May 2015 and March 2018 with an MRI score Likert 1 to 3 were included in the study. Patients had either a CaP diagnosis at MRI-targeted biopsy or were not diagnosed and attended follow-up in the community. Outcomes were analysed through the Kaplan-Meier estimator and Cox Model. Regression coefficients of significant variables were used to develop a Risk of significant Cancer of the Prostate score (RosCaP). RESULTS: At first assessment 281/469 patients had mpMRI only and 188/469 mpMRI and biopsy, 26 csCaP were found at biopsy, including 10/26 in Likert 3 patients. 12/371 patients discharged without CaP after first assessment were diagnosed with csCaP during a median of 34.2 months' follow-up, 11/12 diagnosis occurred in patients omitting initial biopsy. csCaP diagnosis-free survival was 95.7% in the MRI group and 99.1% in the biopsy group. From these outcomes, a continuous RosCaP score was developed: RosCaP = 0.083 x Age - 0.202 x (1/PSA Density) + 0.786 (if Likert 3), and 4 risk classes were proposed. Limitations include retrospective design and absence of external validation. CONCLUSION: Age, PSA Density and MRI Likert score were significantly associated to the risk of csCaP and utilised to devise the novel RosCap predictive score focused to support risk assessment in patients with negative or equivocal mpMRI results.

Continence-Sparing Techniques in Radical Prostatectomy: A Systematic Review of Randomized Controlled Trials.

Background: Numerous continence-sparing radical prostatectomy techniques have been developed to enhance postoperative early continence (EC) recovery; however, evidence regarding the best approach remains controversial. The objectives are to provide a critical appraisal of various prostatectomy techniques, based on the evidence of quality-assessed randomized control trials (RCTs); to summarize the immediate continence and the EC reported; and to propose a new standardization for continence outcomes reporting. Methods: Data acquired from five medical registries were reported to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards. Evidence from published, English, full-text RCTs reporting postoperative urinary continence outcomes within 6 months from surgery was included. The heterogeneity of surgical techniques and continence definitions did not allow a meta-analysis. All RCTs were critically appraised, and quality assessed. Results: In total, 39 RCTs were included: 19 of 39 studies were low-quality RCTs, presenting small cohort, monocentric, or single-surgeon data. The best RCT-supported evidence is in favor of robot-assisted radical prostatectomy (RARP) compared with laparoscopic radical prostatectomy (LRP) and of the Retzius-sparing (RS) technique over the traditional prostatectomy. Other techniques such as bladder neck and puboprostatic ligament (PPL) preservation, posterior reconstruction with or without combination of anterior suspension technique, and nerve-sparing (NS) approach seem to enhance EC. Oppositely, the endopelvic fascia preservation, bladder neck mucosa eversion/plication/slings, and the selective ligature of dorsal venous complex (DVC) were not significantly associated with EC improvements. RCTs are lacking on pubovesical complex-sparing, seminal vesicle preservation, anterior reconstruction of the puboprostatic collar, musculofascial reconstruction, and DVC suspension to the periosteum of the pubic bone techniques. Conclusions: RARP and RS have high-quality evidence supporting their ability to enhance postoperative EC recovery. NS, bladder neck, and PPL preservation may contribute to better EC recovery, although the evidence level is low. Further multicenter RCTs are needed to establish the optimal combination of standard surgical techniques. A new continence outcome-reporting standardization was proposed.

Survey on prostate MRI reading and interpretation among urology residents in Italy, Brazil and the UK: a cry for help.

BACKGROUND: Prostate MRI is an essential tool in the diagnostic pathway of prostate cancer and its accurate reading helps decision to biopsy. The aim of this study was to assess the Urology residents' level of confidence in reading and interpreting prostate MRI, their interest in new learning opportunities and whether prostate MRI training should be part of the urology core curriculum during residency. METHODS: A 23-item survey has been created and distributed via Web to an international cohort of Urology residents over a 3-month period. Surveys obtained from Countries representing >10% total distribution of responses were analyzed. RESULTS: A total of 304 complete surveys were obtained from Urology residents, with a geographical prevalence from Europe (59.54%, 181/304) and South America (29.28%, 89/304). Only 17-20% of residents reported having received formal prostate MRI training during residency. Overall, <20% residents expressed to feel confident in reading and interpreting prostate MRI. As a result, >90% Urology trainees stated they would be willing to receive a formal training and would be interested in new learning opportunities in MRI reading and interpretation during residency, independently of their year of training. Despite UK Urology trainees showed to have a higher availability of MRI resources and MRI-based biopsies compared to the other countries, they still expressed concerns in regard to not feeling confident with MRI reading and interpretation and requested a formal training. CONCLUSIONS: This survey highlights the need for major learning opportunities and a formal training in prostate MRI reading and interpretation during urology residency.

External Validation of the "Tor Vergata" 3D Printed Models of the Upper Urinary Tract and Stones for High-Fidelity Simulation of Retrograde Intrarenal Surgery.

Introduction: Novel training modalities are being investigated to overcome the challenges associated with learning retrograde intrarenal surgery (RIRS). Consequently, a series of 3D printed models of the upper urinary tract and stones designed for ex vivo surgical simulation was introduced in 2021. This study aims to provide external validation of the training model and assess its role in the development of surgical skills. Materials and Methods: A mixed cohort of 20 urologists at different levels of expertise participated in a whole-day live simulation event to examine the model and perform a timed simulation of intrarenal navigation, stone relocation, and laser fragmentation. Operative times were recorded and two independent expert endourologists scored the simulations according to a modified "Objective Structured Assessment of Technical Skills" (OSATS) scale. Five novice urologists from the cohort performed three further simulations in a subsequent event to assess improvement in surgical skills. Results: Face validity was demonstrated with a median score of ≥4/5 in each of the 11 items investigated. Content validity was also effectively reached, with 100% positive impressions with regard to the usefulness for the acquisition of surgical skills. Significant differences were observed among operative times stratified per surgeon experience (all p < 0.0050), thus providing construct validity. Median total OSATS score for novices was 14 (range 8, 25) and was found to be significantly different from expected expert performance (p = 0.0010). Repeated simulations by novices led to a progressive reduction of operative times (p = 0.0313) and increase in median total OSATS (p = 0.0625). Conclusion: The 3D printed models of upper urinary tract and synthetic training stones for the high-fidelity simulation of each phase of RIRS were validated by this study. The results encourage the usage of the models in simulation courses and the evaluation of their potential role in standardized training curricula.

Optimal biopsy approach for detection of clinically significant prostate cancer.

Prostate cancer (PCa) diagnostic and therapeutic work-up has evolved significantly in the last decade, with pre-biopsy multiparametric MRI now widely endorsed within international guidelines. There is potential to move away from the widespread use of systematic biopsy cores and towards an individualised risk-stratified approach. However, the evidence on the optimal biopsy approach remains heterogeneous, and the aim of this review is to highlight the most relevant features following a critical assessment of the literature. The commonest biopsy approaches are via the transperineal (TP) or transrectal (TR) routes. The former is considered more advantageous due to its negligible risk of post-procedural sepsis and reduced need for antimicrobial prophylaxis; the more recent development of local anaesthetic (LA) methods now makes this approach feasible in the clinic. Beyond this, several techniques are available, including cognitive registration, MRI-Ultrasound fusion imaging and direct MRI in-bore guided biopsy. Evidence shows that performing targeted biopsies reduces the number of cores required and can achieve acceptable rates of detection whilst helping to minimise complications and reducing pathologist workloads and costs to health-care facilities. Pre-biopsy MRI has revolutionised the diagnostic pathway for PCa, and optimising the biopsy process is now a focus. Combining MR imaging, TP biopsy and a more widespread use of LA in an outpatient setting seems a reasonable solution to balance health-care costs and benefits, however, local choices are likely to depend on the expertise and experience of clinicians and on the technology available.

Corrigendum: Is urology a gender-biased career choice? A survey-based study of the Italian medical students'; perception of specialties.

[This corrects the article DOI: 10.3389/fsurg.2022.962824.].

Laparoscopy in Low-Income Countries: 10-Year Experience and Systematic Literature Review.

Laparoscopy is a procedure that ultimately reduces hospital stay time and speeds up post-operative recovery. It is mainly performed in high-income countries but its implementation in many low- and middle-income countries (LMICs) is increasing. However, no aggregate data exist regarding the outcomes of this procedure in resource-limited settings. We retrospectively reviewed all cases of laparoscopy recorded from January 2007 to March 2017 at the Department of Surgery of Beira to assess the related outcomes. Moreover, we performed a systematic review of the laparoscopic practices and outcomes in low-income countries. Data from the Department of Surgery of Beira identified 363 laparoscopic procedures, mainly relating to gynecological diseases, cholelithiasis, and appendicectomy with only a 1.6% complication rate (6 cases) and a 1.9% conversion rate (7 cases) to open surgery. The systematic review showed a pooled risk of overall complications significantly lower in laparoscopic vs. open appendicectomy (OR = 0.43; 95% CI 0.19-0.97; I2 = 85.7%) and a significantly lower risk of infection (OR = 0.53; 95% CI 0.43-0.65; I2 = 0.00%). The pooled SMD in operation duration in laparoscopic vs. open appendectomy was 0.58 (95% CI -0.00; 1.15; I2 = 96.52), while the pooled SMD in hospitalization days was -1.35 (95% CI -1.87; -0.82; I2 = 96.41). Laparoscopy is an expensive procedure to adopt as it requires new equipment and specialized trained health workers. However, it could reduce post-operative costs and complications, especially in terms of infections. It is crucial to increase its accessibility, acceptability, and quality particularly in LMICs, especially during this COVID-19 era when the reduction of patient hospitalization is essential.

Long-term effects of laparoscopic sleeve gastrectomy versus Roux-en-Y gastric bypass for the treatment of morbid obesity: a monocentric prospective study with minimum follow-up of 5 years.

Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are the most widely used bariatric procedures nowadays. The aim of this study was to compare long-term results on weight loss and comorbidities improvement for both procedures. A cohort of 304 consecutive patients underwent surgery in 2006-2009: 162 underwent LSG and 142 underwent LRYGB. The mean follow-up time was 75.8 ± 8.4 months (range 60-96). LSG showed greater effectiveness in percentage of excess weight loss (%EWL) at 180 days and at 1 year of follow-up. Instead, at 5th year follow-up LRYGB and LSG showed similar %EWL values (72.34 versus 70.26). LSG group showed a lack of weight loss in patients from 3 to 5 years after surgery, whereas LRYGB group patients maintained an effective weight loss during the entire follow-up period. In LSG group both length of stay and operative time were found to be shorter. LRYGB showed better effectiveness in type 2 diabetes mellitus (T2DM) resolution rate. None of the two techniques has proven to be clearly better than the other on a long-term follow-up analysis, except for the LRYGB better results in T2DM healing. According to our findings, in LSG Group after 3 years the weight remains stable.

Laparoscopic Sleeve Gastrectomy versus Laparoscopic Banded Sleeve Gastrectomy: First Prospective Pilot Randomized Study.

Introduction. The placement of ring or band around the gastric tube might prevent the dilation after Laparoscopic Sleeve Gastrectomy (LSG). We describe the first randomized study comparing LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG). Material and Method. Fifty obese patients were enrolled in the study between January 2014 and January 2015. We analysed differences in operative time, complication rate, mortality, and BMI between the two groups over a period of 12 months. Results. Twenty-five patients received LSG (group A) and 25 LBSG (group B). The mean preoperative BMI was 47.3 ± 6.58 kg/m(2) and 44.95 ± 5.85 kg/m(2), respectively, in the two groups. There was no statistical relevant difference in operative time. No intraoperative complications occurred. Mean BMI registered after 3, 6, and 12 months in groups A and B, respectively, were 37.86 ± 5.72 kg/m(2) and 37.58 ± 6.21 kg/m(2) (p = 0.869), 33.64 ± 6.08 kg/m(2) and 32.03 ± 5.24 kg/m(2) (p = 0.325), and 29.72 ± 4.40 kg/m(2) and 27.42 ± 4.47 kg/m(2) (p = 0.186); no statistical relevant difference was registered between the two groups. Conclusion. LBSG is a safe and feasible procedure. The time required for the device positioning did not influence significantly the surgical time. The results of bodyweight loss did not document any statistically significant differences among the two groups, even though LBSG group showed a mean BMI slightly lower than that of the control group.