An umbrella review of the surgical performance of Harmonic ultrasonic devices and impact on patient outcomes.

BACKGROUND: For thirty years, the Harmonic scalpel has been used for precise dissection, sealing and transection. There are numerous meta-analyses on individual surgical procedures with Harmonic, but no overarching review covering all the areas. This umbrella review seeks to summarize the clinical results from the use of Harmonic across surgical fields and broadly quantify its effects on patient outcomes. METHODS: MEDLINE, EMBASE, and Cochrane Databases were searched for meta-analyses (MAs) of randomized controlled trials (RCTs) comparing Harmonic devices to conventional techniques or advanced bipolar (ABP) devices. For each procedure type, the most comprehensive MAs were evaluated. RCTs not already analysed in a MA were also included. Operating time, length of stay, intraoperative blood loss, drainage volume, pain, and overall complications were evaluated, and the methodological quality and certainty of evidence were assessed. RESULTS: Twenty-four systematic literature reviews were identified on colectomy, hemorrhoidectomy, gastrectomy, mastectomy, flap harvesting, cholecystectomy, thyroidectomy, tonsillectomy, and neck dissection. There were also 83 RCTs included. In every MA evaluated, Harmonic devices were associated with either statistically significant or numerical improvements in every outcome compared with conventional techniques; most MAs reported a reduction in operating time of ≥ 25 min. Harmonic versus ABP device MAs in colectomy and thyroidectomy showed no significant differences in outcomes. CONCLUSION: Across surgical procedures, Harmonic devices demonstrated improved patient outcomes for operating time, length of stay, intraoperative bleeding, drainage volume, pain, and overall complications compared to conventional techniques. Additional studies are required to assess differences between Harmonic and ABP devices.

Adopting a portfolio of ultrasonic and advanced bipolar electrosurgery devices from a single manufacturer compared to currently used ultrasonic and advanced bipolar devices: a probabilistic budget impact analysis from a Spanish hospital perspective.

AIMS: Advanced energy devices are commonly used in electrosurgery, including ultrasonic and advanced bipolar (ABP) devices. Smoke evacuation and reusable dispersive electrodes are also utilized during electrosurgery to improve staff and patient safety. This study assessed the budget impact of adopting a portfolio of Ethicon energy devices compared to devices from other manufacturers from a Spanish hospital perspective. METHODS: The main analysis compared the Ethicon advanced energy device portfolio (ultrasonic and ABP devices) to Non-Ethicon advanced energy devices. It was assumed that 4,000 procedures using one advanced energy device each were performed annually, and the cost impact of operating room time, length of stay, and transfusions were considered. A probabilistic budget impact analysis with 10,000 iterations was conducted for generalizability to other hospitals in Spain and Europe. Secondary analysis assessed whether cost savings from the Ethicon advanced energy device portfolio could offset costs of adopting smoke evacuation and reusable dispersive electrodes (Full Ethicon energy portfolio). RESULTS: In the main analysis, the annual budget impact of introducing the Ethicon advanced energy device portfolio was cost saving in 79.8% of probabilistic iterations (mean: -€945,214; 95% credible interval [CrI]: -€3,242,710; €1,285,942) with a mean budget impact per procedure of -€236 (95% CrI: -€811; €321). In the secondary analysis, adding smoke evacuation and reusable dispersive electrodes was still cost saving in 75.3% of iterations compared to Non-Ethicon advanced energy devices (mean: -€778,208; 95% CrI: -€3,075,086; €1,464,728) with a mean budget impact per procedure of -€97 (95% CrI: -€384; €183). Savings resulted from differences in operating room time, length of hospital stay, and volume of disposable electrodes. CONCLUSIONS: Adopting Ethicon advanced energy devices demonstrated economic benefits compared to non-Ethicon devices. Introducing the advanced portfolio may improve surgical care quality and the full portfolio was cost saving while improving OR safety for staff and patients.

This study created an economic model to calculate whether using modern electrical surgical tools with features to make cutting tissue and stopping bleeding faster and easier could save Spanish hospitals money. The electrical surgery tools from one manufacturer were compared to those from various other companies. Differences in how long surgery took to perform, how long patients stayed in hospital after their surgery, and how many blood transfusions they needed were considered in the model. The model was tested 10,000 times with random changes in the costs and settings used to be surer about the range of possible results. The results showed the devices from one manufacturer could save a Spanish hospital money in almost 80% of model runs and that savings worked out to €236 per surgery. In another analysis, savings were enough to cover the cost of introducing safety devices to remove surgical smoke from the operating room and reusable patient grounding electrodes that prevent some injuries potentially caused by small sticky electrodes. In conclusion, the model showed that Spanish hospitals may be able to save money by switching to the modern electrical surgery tools from Ethicon.

Intraoperative Measures to Reduce the Risk of COVID-19 Transmission During Minimally Invasive Procedures: A Systematic Review and Critical Appraisal of Societies' Recommendations.

BACKGROUND: The coronavirus 2019 pandemic and the hypothetical risk of virus transmission through aerosolized CO2 or surgical smoke produced during minimally invasive surgery (MIS) procedures have prompted societies to issue recommendations on measures to reduce this risk. The aim of this systematic review is to identify, summarize and critically appraise recommendations from surgical societies on intraoperative measures to reduce the risk of severe acute respiratory syndrome coronavirus 2 transmission to the operative room (OR) staff during MIS. METHODS: Medline, Embase, and Google Scholar databases were searched using a search strategy or free terms. The search was supplemented with searches of additional relevant records on coronavirus 2019 resource websites from Surgical Associations and Societies. Recommendations published by surgical societies that reported on the intraoperative methods to reduce the risk of severe acute respiratory syndrome coronavirus 2 transmission to the OR staff during MIS were also reviewed for inclusion. Expert opinion articles were excluded. A preliminary synthesis was performed of the extracted data to categorize and itemize the different types of recommendations. The results were then summarized in a narrative synthesis. RESULTS: Thirty-three recommendation were included in the study. Most recommendations were targeted to general surgery (13) and gynecology (8). Areas covered by the documents were recommendations on performance of laparoscopic/robotic surgery versus open approach (28 documents), selection of surgical staff (13), management of pneumoperitoneum (33), use of energy devices (20), and management of surgical smoke and pneumoperitoneum desufflation (33) with varying degree of consensus on the specific recommendations among the documents. CONCLUSIONS: While some of the early recommendations advised against the use of MIS, they were not strictly based on the available scientific evidence. After further consideration of the literature and of the well-known benefits of laparoscopy to the patient, later recommendations shifted to encouraging the use of MIS as long as adequate precautions could be taken to protect the safety of the OR staff. The release and implementation of recommendations should be based on evidence-based practices that allows health care systems to provide safe surgical and medical assistance.

A device category economic model of electrosurgery technologies across procedure types: a U.S. hospital budget impact analysis.

AIMS: The electrosurgical technology category is used widely, with a diverse spectrum of devices designed for different surgical needs. Historically, hospitals are supplied with electrosurgical devices from several manufacturers, and those devices are often evaluated separately; it may be more efficient to evaluate the category holistically. This study assessed the health economic impact of adopting an electrosurgical device-category from a single manufacturer. METHODS: A budget impact model was developed from a U.S. hospital perspective. The uptake of electrosurgical devices from EES (Ethicon Electrosurgery), including ultrasonic, advanced bipolar, smoke evacuators, and reusable dispersive electrodes were compared with similar MED (Medical Energy Devices) from multiple manufacturers. It was assumed that an average hospital performed 10,000 annual procedures 80% of which involved electrosurgery. Current utilization assumed 100% MED use, including advanced energy, conventional smoke mitigation options (e.g. ventilation, masks), and single-use disposable dispersive electrode devices. Future utilization assumed 100% EES use, including advanced energy devices, smoke evacuators (i.e. 80% uptake), and reusable dispersive electrodes. Surgical specialties included colorectal, bariatric, gynecology, thoracic and general surgery. Systematic reviews, network meta-analyses, and meta-regressions informed operating room (OR) time, hospital stay, and transfusion model inputs. Costs were assigned to model parameters, and price parity was assumed for advanced energy devices. The costs of disposables for dispersive electrodes and smoke-evacuators were included. RESULTS: The base-case analysis, which assessed the adoption of EES instead of MED for an average U.S. hospital predicted an annual savings of $824,760 ($101 per procedure). Savings were attributable to associated reductions with EES in OR time, days of hospital stay, and volume of disposable electrodes. Sensitivity analyses were consistent with these base-case findings. CONCLUSIONS: Category-wide adoption of electrosurgical devices from a single manufacturer demonstrated economic advantages compared with disaggregated product uptake. Future research should focus on informing comparisons of innovative electrosurgical devices.

Economic and clinical outcomes of spinal fusion surgeries with skin closure through skin staples plus waterproof wound dressings versus 2-octyl cyanoacrylate plus polymer mesh tape.

BACKGROUND CONTEXT: Spinal fusion surgeries are one of the most common types of operations performed during inpatient stays in the United States. Successful wound closure, including watertight closure at the skin layer, plays in important role in patient outcomes. PURPOSE: To compare the economic and clinical outcomes of spinal fusion surgeries using one of two sutureless skin closure techniques: skin staples plus waterproof wound dressings (SSWWD) or 2-octyl cyanoacrylate plus polymer mesh tape (2OPMT). STUDY DESIGN/SETTING: Retrospective study using a multi-hospital database. PATIENT SAMPLE: Patients undergoing inpatient spinal fusion surgery for a spine disorder between October 1, 2015 and March 31, 2019. OUTCOME MEASURES: Total costs from the hospital perspective, operating room time (ORT), hospital length of stay (LOS), non-home discharge, infection/wound complications during the 90-day global period (index surgery through 90 days post-discharge), and 30/60/90-day all-cause readmissions. METHODS: Outcomes were compared between study groups using nearest neighbor propensity score matching with exact matching on 45 primary procedure/diagnosis code groupings and generalized estimating equations to account for hospital-level clustering. This study was sponsored by Ethicon, Inc., a Johnson & Johnson company; the authors are employees or consultants of Johnson & Johnson. RESULTS: A total of 11,991 patients met the study criteria (2OPMT=5,961; SSWWD=6,030), of which 3,602 were included in each post-match study comparison group (total=7,204). As compared with the SSWWD group, the 2OPMT group had statistically significant lower median ORT (240 vs. 270 minutes; p=0.002), mean LOS (3.35 [SD=2.6] vs. 3.86 [SD=2.8] days, p=0.031), risks of non-home discharge status (17.63% vs. 23.10%, p=0.035), overall infections/wound complications (1.37% vs. 2.48%, p=0.015), and surgical site infection (1.11% vs. 2.07%, p=0.023). Differences between the study groups in total hospital costs, all-cause readmissions, and other sub-components of the infection/wound complication composite outcome were statistically insignificant (p>0.05). CONCLUSIONS: In this retrospective observational study of patients undergoing elective inpatient spinal fusion surgery, the use of 2OPMT for skin closure was associated with significantly lower ORT, LOS, non-home discharge, and 90-day rates of infections/wound complications as compared with SSWWD.

Clinical and economic outcomes of cesarean deliveries with skin closure through skin staples plus waterproof wound dressings versus 2-octyl cyanoacrylate plus polymer mesh tape.

PURPOSE: To compare clinical and economic outcomes of cesarean deliveries with skin closure through skin staples plus waterproof wound dressings (SSWWD) versus 2-octyl cyanoacrylate plus polymer mesh tape (2OPMT). We hypothesized that cesarean deliveries with skin closure through 2OPMT may be associated with a lower rate of wound complications and infections as compared with skin closure through SSWWD; we also hypothesized that, accordingly, 2OPMT may be associated with lower hospital length of stay (LOS), hospital costs, and all-cause readmissions as compared with SSWWD. METHODS: Retrospective, observational study using a research database derived from administrative records routinely contributed by hundreds of hospitals in the USA. We queried the database for patients aged 18-49 years who had an in-hospital low transverse cesarean delivery between 1 January, 2012 and 31 March, 2017. Using records of medical supplies used during deliveries, we identified deliveries for which skin closure was performed by either SSWWD (SSWWD group) or 2OPMT (2OPMT group). Our primary study outcome was a composite endpoint of infection/wound complication diagnosis during the hospital stays in which the deliveries were performed. Our secondary outcomes included: length of stay (LOS) and total hospital costs for the hospital stays in which the deliveries were performed, and all-cause readmissions (30/60/90 days post discharge) to the same hospital in which the delivery was performed. We compared outcomes between propensity-score matched groups using regressions accounting for hospital-level clustering and non-Gaussian empirical outcome distributions. RESULTS: Each group comprised 2133 patients (4266 total patients; mean age = 30.3 years [SD = 4.6]). Compared with the SSWWD group, the 2OPMT group had statistically significant lower rates of complications (infection, 0.7 versus 1.6%, p = .011; wound complication, 0.6 versus 1.3%, p = .036; composite, 0.9 versus 2.0%, p = .002), shorter LOS (mean = 3.5 days [SD = 1.6] versus 3.7 days [SD = 1.8], p = .007), and lower total hospital costs (mean = $8879 [SD = $3157] versus $9313 [SD = $3311], p = .025). Between-group differences for 30/60/90-day all-cause readmissions were statistically insignificant. CONCLUSIONS: This large observational study is the first of its kind and provides evidence that cesarean delivery skin closure with 2OPMT is associated with lower rates of in-hospital infection and wound complications, lower LOS, lower total hospital costs as compared with SSWWD.

Barbed and conventional sutures in spinal surgery patients: an economic and clinical outcomes comparison.

OBJECTIVE: To compare economic and clinical outcomes of barbed sutures versus conventional sutures alone in wound closure for patients undergoing spinal surgery. METHOD: A retrospective study using the Premier Healthcare Database. The database was searched for patients who underwent elective inpatient spinal surgery (fusion or laminectomy) for a spinal disorder between 1 January 2014 and 30 June 2018 (first=index admission). Using billing records for medical supplies used during the index admission, patients were classified into mutually-exclusive groups: patients with any use of STRATAFIX (Ethicon, US) knotless tissue control devices (barbed sutures group); or patients with use of conventional sutures alone (conventional sutures group). Outcomes included the index admission's length of stay, total and subcategories of hospital costs, non-home discharge, operating room time (ORT, minutes), wound complications and readmissions within ≤90 days. Propensity score matching and generalised estimating equations were used to compare outcomes between the study groups. RESULTS: After matching, 3705 patients were allocated to each group (mean age=61.5 years [standard deviation, SD±12.9]; 54% were females). Compared with the conventional suture group, the barbed suture group had significantly lower mean ORT (239±117 minutes, versus 263±79 minutes conventional sutures, p=0.015). Operating room costs were also siginificantly lower in the barbed suture group ($6673±$3976 versus $7100±$2700 conventional sutures, p=0.020). Differences were statistically insignificant for other outcomes (all p>0.05). Subanalysis of patients undergoing fusions of ≥2 vertebral joints yielded consistent results. CONCLUSION: In this study, wound closure incorporating barbed sutures was associated with lower ORT and operating room costs, with no significant difference in wound complications or readmissions, when compared with conventional sutures alone.

Tension-free Vaginal Tape-Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence: Efficacy and Adverse Effects at 10-year Follow-up.

BACKGROUND: Inside-out transobturator tape (tension-free vaginal tape-obturator [TVT-O]) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI). However, data reporting long-term outcomes are lacking. OBJECTIVE: To assess the efficacy and safety of TVT-O 10 yr after implantation for the treatment of female pure SUI. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, prospective study was conducted in five tertiary referral centers in three countries. All consecutive women with urodynamically proven pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. INTERVENTION: TVT-O implantation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes. RESULTS AND LIMITATIONS: One hundred sixty-eight women had TVT-O implantation. At 10-yr follow-up, 160 patients (95%) were available for the evaluation. We did not find any significant change of the surgical outcomes during this time. At 10 yr after surgery, 155 of 160 patients (97%) declared themselves cured (p=0.7). Similarly, at 10-yr evaluation, 148 of 160 patients (92%) were objectively cured. No significant deterioration of objective cure rates was observed over time (p=0.4). The history of failure of previous anti-incontinence procedures (hazard ratio: 5.34; 95% CI, 2.61-11.9; p=0.009) was the only predictor of recurrence of SUI. The onset of de novo overactive bladder was reported by 23 of 160 patients (14%) at 10-yr follow-up. No other late complications were reported. CONCLUSIONS: The 10-yr results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI. PATIENT SUMMARY: At long-term follow up, tension-free vaginal tape-obturator is highly effective and safe for the treatment of stress urinary incontinence.

Efficacy and safety of the trans-obturator TVT-Abbrevo device in normal weight compared to overweight patients affected by stress urinary incontinence.

OBJECTIVE: To investigate if TVT-Abbrevo has similar outcomes in normal weight and overweight patients. STUDY DESIGN: Retrospective evaluation of 205 (105 normal weight women and 100 overweight women with BMI ≥ 25 kg/m(2)) undergone TVT-Abbrevo positioning with 12 month follow-up. Primary outcomes were objective cure rate (defined as no leakage during CST) and subjective cure rate ("very much improved"/"much improved" at PGI-I), secondary outcomes were intra-operative and post-operative complications. RESULTS: Objective cure rates in the normal and overweight groups were 96.2% and 94%, respectively (p=.47). Subjective cure rates in the normal and overweight groups were 90.5% and 88%, respectively (p=.57). ICIQ-SF, I-QoL and PGI-S scores significantly improved in both groups with no differences between the two groups. No serious intra- or post-operative complications were observed. No differences were observed in pain VAS scores and number of analgesic vials administered. CONCLUSIONS: TVT-Abbrevo seems to have similar efficacy and safety in normal weight and overweight women. More studies are needed to assess the efficacy of this device in frankly obese women and long-term outcomes.

A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females.

AIMS: Evaluate the efficacy, safety, and tolerability of a novel pressure-attenuation balloon for the treatment of female stress urinary incontinence (SUI) using a prospective, randomized, single-blind, multi-center design, evaluated at 3 months. METHODS: Sixty-three females with SUI were randomized 2:1 to treatment with a balloon (N = 41) or sham procedure (N = 22). The sham (control) entailed the same procedure without the deployment of a balloon. Endpoints were evaluated at 3 months and included a composite endpoint that required both ≥10 point increase in the 22-item Incontinence Quality of Life Survey (I-QOL) and ≥50% decrease in provocative pad weight. Additional endpoints included incontinence episode frequency, and PGII assessment. RESULTS: In an ITT analysis, 63% of women in the treatment group achieved the composite endpoint, compared to 31% in the Control Group (P = 0.0200). In a per protocol analysis, 81% of women in the treatment arm had a 50% decrease in pad weight test vs. 45% in the Control Group (P = 0.0143); 41.6% of the treatment patients were dry on pad weight test (≤1gram) vs. 0% in the Control Group (P < 0.001), and 58% of treated patients reported improvement on a PGII assessment versus 25% of women in the Control Group (P = 0.025). Adverse events in the treatment group included dysuria (14.6%), gross hematuria (9.8%), and UTI (7.3%). CONCLUSIONS: This minimally invasive treatment for female SUI with an intravesical pressure-attenuation balloon was safe and effective. The concept of pressure attenuation as a therapy for SUI is valid and feasible for those patients that can tolerate the balloon.

Medium-term and long-term outcomes following placement of midurethral slings for stress urinary incontinence: a systematic review and metaanalysis.

INTRODUCTION AND HYPOTHESIS: Questions regarding the long-term efficacy and safety of midurethral slings (MUS) are still unresolved, notwithstanding the widespread use of these procedures. The objective of this review was to evaluate the long-term outcomes of retropubic MUS (RP-MUS) procedures and the medium-term outcomes of transobturator MUS (TO-MUS) procedures. METHODS: MEDLINE, EMBASE, NLH, ClinicalTrials.gov, and Google Scholar databases were searched up to June 2014 with restriction to English language and using the search terms: "stress urinary incontinence", "midurethral sling", "tension-free tape", "transobturator tape", and "follow-up". Studies with a follow-up of 36 months for TO-MUS and 60 months for RP-MUS were searched. Only studies comparing a RP-MUS or TO-MUS with another synthetic sling were included. Data from 49 studies were included. Data were expressed as odds ratios (OR) with 95 % confidence intervals (CI) and combined using the Mantel-Haenszel fixed effects model. Differences in the proportions were evaluated using the chi-squared test. RESULTS: RP-MUS had similar objective cure rates (OR 1.15, 95 % CI 0.75 - 1.76) but higher subjective cure rates than TO-MUS (OR 1.76, 95 % CI 1.08 - 2.86). No differences were observed between outside-in (TOT) and inside-out (TVT-O) and between TO-MUS and minisling. Bladder injuries were more frequent (OR 7.01, 95 % CI 2.94 - 17.90) and vaginal erosions were less frequent for RP-MUS (OR 0.24, 95 % CI 0.07 - 0.84). Vaginal injuries were more common with TOT than with TVT-O (OR 7.96, 95 % CI 1.15 - 157.9). Pain-related complications were more common with TO-MUS than with minimally invasive tapes (OR 8.75; 95 % CI 9.02 - 57.90). CONCLUSIONS: MUS have similar objective cure rates in the long term and medium term. TO-MUS is associated with a lower subjective cure rate than RP-MUS.

Tension-free vaginal tape-obturator and tension-free vaginal tape-Secur for the treatment of stress urinary incontinence: a 5-year follow-up randomized study.

OBJECTIVE: Single-incision slings were developed to overcome the complications related to retropubic and trans-obturator tapes. TVT-Secur was the first of this kind of devices to be marketed and yielded contrasting results. Aim of this non-inferiority study is to report the 5-year follow-up of a randomized, single-blind, controlled trial comparing TVT-O to TVT-Secur. STUDY DESIGN: Randomized, single blind, controlled study conducted in two tertiary urogynecological centers. 154 patients were allocated to either TVT-O or TVT-Secur and were contacted 5 years after the procedure to undergo urogynecological examination (POP-Q staging, challenge stress test and post-void residual urine evaluation), to complete I-QOL and PGI-I questionnaires, and to score their satisfaction on a 5-point Likert scale. Patients who were not objectively evaluated were interviewed over the telephone. Primary outcome was subjective success defined as being "very much improved" or "much improved" on the PGI-I. RESULTS: 120 patients were evaluated only subjectively (TVT-O: 62; TVT-Secur: 58) and 84 objectively and subjectively (TVT-O: 46; TVT-Secur: 38). Subjective success (79% vs. 63.8%) and objective cure rates (82.6% vs. 68.4%) 5 years after the procedure were lower for TVT-Secur, but not significantly. Recurrent UTIs were reported by 17.8% of women (TVT-O 9, TVT-Secur 6) and two de novo urgency cases (one per group) were observed. Re-operation rate for stress urinary incontinence (SUI) was 20%. CONCLUSIONS: TVT-Secur did not show an inferior subjective success rate in comparison with TVT-O five year after the original procedure, even though displaying a clear trend toward a lower efficacy. Considering that the long-term safety profile is similar between the two procedures, there are no advantages in using TVT-Secur.

Effect of local infiltration analgesia on post-operative pain following TVT-O: a double-blind, placebo-controlled randomized study.

PURPOSE: To evaluate the effect of a protocol of local anesthesia and epinephrine associated with sedo-analgesia on post-TVT-O pain in comparison with infiltration of saline and epinephrine. METHODS: Forty-two patients undergoing TVT-O were randomized into two groups to receive periurethral infiltration with epinephrine only (group A, n = 21) or with epinephrine plus 1 % lidocaine hydrochloride (group B, n = 21). Post-operative pain was assessed using a visual analog scale (VAS) from 0 (absence of pain) to 10 (maximum pain possible), 1, 6, 12 and 24 h after the procedure. The total amount of analgesia was recorded and the proportion of women reporting a pain VAS score ≥4, 1 h after the procedure was calculated. ANOVA for repeated measures and Bonferroni correction, the Student's t test for independent samples, the Mann-Whitney U test, the Fisher exact test, or the χ (2) test for parametric was used. RESULTS: Pain level was significantly lower in group B 1 (p = 0.01) and 6 h (p = 0.05) after surgery, but not 12 and 24 h after the procedure. No significant difference was observed in the proportion of women requesting analgesia and in the total dosage of analgesics between the two groups. A significant higher proportion of women in group A reported a pain VAS score higher than four 1 h after surgery in comparison with patients in group B. CONCLUSIONS: This randomized study seems to indicate that systematic infiltration before TVT-O positioning with local anesthetic may reduce immediate post-operative pain.

Effects of an oral contraceptive containing estradiol valerate and dienogest on circulating androgen levels and acne in young patients with PCOS: an observational preliminary study.

This study shows the effect of a 1 year treatment with an estradiol valerate/dienogest pill in 36 women suffering from polycystic ovaries and mild or moderate acne. At beginning of the study, 24 patients (66.7%) had grade 1-2 (mild) acne and 12 patients (33.3%) had grade 3 (moderate) acne. After 12 cycles of therapy, we found an improvement of acne in 19 (52.8%) patients and a worsening of acne in 3 (8.4%) patients. The percentage of patients recovered was statistically significant (p < 0.01). SHBG levels were significantly higher after 6 and 12 months of therapy (p < 0.001), while total testosterone levels were lower in all patients at 6 and 12 months although this trend did not reach statistical significance. In conclusion, the present study suggests that the E2V/DNG pill could exert a positive influence on acne and hyperandrogenism. Since this is an observational study on a very limited population number, additional randomized controlled studies on larger populations are needed also to determine the effects of this contraceptive over longer periods of use.

Short-term effects of an oral contraceptive containing oestradiol valerate and dienogest on bone metabolism and bone mineral density: an observational, preliminary study.

OBJECTIVES: To evaluate the effects of a combined oral contraceptive (COC) containing dienogest/oestradiol valerate (DNG/E2V) on bone mineral density (BMD) and on serum and urinary bone turnover markers in young, healthy, fertile women. METHODS: At baseline and after three and six months of intake of the aforementioned COC, serum and urinary calcium, osteocalcin, urinary pyridinoline (PYD), and deoxypyridinoline (D-PYD) of 30 women aged 21 to 34 years were measured. At baseline and after six months, lumbar bone mineral density was determined by dual-energy X-ray absorptiometry (DEXA). RESULTS: Urinary levels of PYD and D-PYD were significantly lower at three and six months in comparison with basal values (p < 0.05). Serum calcium levels showed an increasing trend, which reached statistical significance after six months in comparison with basal values while urinary levels of calcium did not vary significantly. Serum osteocalcin levels were somewhat, but not significantly, lower during pill use in comparison with basal values. After six months, spinal BMD values did not differ significantly from basal values. CONCLUSIONS: The DNG/E2V COC has no short-term adverse effect on bone turnover markers. No significant change in BMD was observed after six months of use of that pill.

Tension-free vaginal tape-O and -Secur for the treatment of stress urinary incontinence: a thirty-six-month follow-up single-blind, double-arm, randomized study.

OBJECTIVE: To compare the efficacy of the inside-out tension-free vaginal tape-obturator (TVT-O) device versus the single-incision TVT-Secur device 36 months after the procedure. METHODS: A single-blind, randomized, parallel-group study on 154 patients with stress urinary incontinence (77 treated with TVT-O and 77 with the TVT-Secur hammock approach). The primary endpoint was the objective cure rate 36 months after the procedure evaluated with the challenge stress test. Secondary endpoints were subjective cure rate (evaluated with bladder diary, quality-of-life questionnaires, and patient-reported outcome tools) and intraoperative and postoperative complications. The primary endpoint was evaluated with a noninferiority study design. RESULTS: Sixty-six patients in the TVT-O group and 64 in the TVT-Secur group concluded the study. Thirty-six months after the procedure, 57/66 patients (86.4%) in the TVT-O and 50/64 (78.1%) in the TVT-Secur groups were objectively cured (noninferiority unilateral u test: p < .05). No differences were observed in the subjective cure and complication rates. CONCLUSIONS: TVT-Secur seems not to be inferior to TVT-O in the surgical treatment of stress urinary incontinence and causes less postoperative pain. The possibility of severe blood loss cannot be ruled out when TVT-Secur is used.

Efficacy of a modified technique for TVT-O positioning: a twelve-month, randomized, single-blind, multicenter, non-inferiority study.

OBJECTIVE: To evaluate the impact of a more limited paraurethral dissection, avoidance of perforating the obturator membrane with scissors or guide, and a more medial trajectory of the trocar in positioning the TVT-O device on stress urinary incontinence cure rates. STUDY DESIGN: One hundred and ten patients were recruited for this randomized, single blind, multicenter, non-inferiority study, with a 1:1 ratio to undergo the traditional (n=55) or the modified (n=55) technique. Preoperatively, patients underwent POP-Q staging, Q-tip test, challenge stress test and urodynamics, and completed the I-QoL, PISQ-12, and PGI-S questionnaires. During the post-operative period, patients attributed a pain VAS score 1, 3, 6, 12 and 24h after the procedure and were followed up at 12 months, undergoing the same baseline evaluations. The primary outcome was the cure rate (absence of urine leaks at the challenge stress test or urodynamic testing) one year after the procedure. The primary outcome was evaluated using a non-inferiority test. RESULTS: No differences were observed in cure rates (traditional technique 92.3% vs. modified technique 88.8% and non-inferiority P<0.05) and in questionnaire scores between the two groups. Post-operative pain was significantly lower in the modified technique group at each time point assessed, with the exception of 12h post-operatively. No differences between the two groups were observed in the number of analgesic vials administered. CONCLUSIONS: The modified technique does not seem to reduce the efficacy of TVT-O, but induces a reduction of post-operative pain.

Vaginal delivery following single incision sling (TVT-Secur) for female stress urinary incontinence.

In recent years, surgical treatment of stress urinary incontinence has become minimally invasive owing to the introduction of the transobturator route first and then single incision devices for positioning of mid-urethral slings. Although a number of case reports in the literature describe pregnancies successfully terminated both by vaginal delivery and cesarean section following mid-urethral sling positioning, there is still no definitive consensus on which is the preferred mode of delivery in these patients. We report a case of spontaneous vaginal delivery at term in a 41-year-old multiparous woman two years after the positioning of a single incision sling (TVT-Secur). The patient remained continent throughout the gestation and in the following 24 months. This case seems to further support the concept that sling procedures for stress urinary incontinence do not represent an absolute contraindication to spontaneous vaginal delivery, although the preferred mode of delivery must be assessed on an individual basis.

Hormonal contraception and bone metabolism: a systematic review.

BACKGROUND: Although a large amount of studies in the literature evaluated the effects of hormonal contraception on bone, many questions remained still unclear, such as the effect of these therapies on fracture risk. STUDY DESIGN: We performed a systematic search of the published studies from January 1975 through January 2012 on the effects of hormonal contraceptives on bone metabolism. We analyzed the overall effect on bone mineral density (BMD) and on fracture risk of combined oral contraceptives (COCs), progestogen-only contraceptives, transdermal contraceptives and vaginal ring. RESULTS: COC therapy does not seem to exert any significant effect on BMD in the general population. In adolescents, the effects of COCs on BMD seem to be mainly determined by estrogen dose. The use of COCs in perimenopausal women seems to reduce bone demineralization and may significantly increase BMD even at a 20-mcg dose. Use of depot medroxyprogesterone acetate is associated with a decrease in BMD, although this decrease seems to be partially reversible after discontinuation. Data on other progestogen-only contraceptives, transdermal patch and vaginal ring are still limited, although it seems that these contraceptive methods do not exert any influence on BMD. CONCLUSIONS: Hormonal contraceptives do not seem to exert any significant effect on bone in the general population. However, other randomized controlled trials are needed to evaluate the effects on fracture risk since the data available are derived from studies having the effects on BMD as the primary end point, and BMD may not accurately reflect the real fracture risk.

The use of an oral contraceptive containing estradiol valerate and dienogest before office operative hysteroscopy: a feasibility study.

To investigate the impact of a 3 months preoperative administration of an oral contraceptive, containing dienogest (DNG) and estradiol valerate (E2V) on the outcome of office operative hysteroscopy (OOH). One-hundred and forty-two patients diagnosed at office hysteroscopy as having an asynchronous endometrium associated with either a broad-base sessile endometrial polyp (>1.5, <2.5 cm) or a uterine septum (>1/3 uterine cavity) or scheduled for tubal sterilization were enrolled into a prospective case-control study at University "Federico II" of Naples. 86/142 patients accepted the preoperative hormonal treatment (Group A), while 56/142 refused, thus becoming controls (Group B). Group A underwent OOH during the 10th-20th days of the third cycle of treatment. In Group B OOH was performed at enrolment, together with the diagnostic procedure. The study outcomes were: endometrial pattern, success rate, operating time, degree of surgical difficulty and pain score. An overall improvement of the endometrium was reported in 100% of cases in Group A. A statistically significant difference in success rate could not be demonstrated between two groups. Operative procedures were performed significantly quicker and easier in Group A than Group B (p < 0.001 and p < 0.05, respectively). The mean Visual Analog Scale (VAS) score was significantly lower in Group A (p < 0.001). A short pretreatment with combined oral contraceptive (COC) containing E2V/DNG seems to have a favorable impact on endometrium which in turn may result in an improvement of the overall outcomes of OOH.