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Background. Topical hemostats reduce blood loss and optimize patient outcome and health care costs. The choice of agent depends on mode of action and surgical situation. This post-market clinical study evaluated the safety and effectiveness of Surgicel®-P, a powdered form of oxidized regenerated cellulose, designed to help control mild-to-moderate bleeding on broad or raw tissue surfaces.Methods. In a prospective, single-arm, multicenter trial, adult subjects with a target bleeding site (TBS) (mild-to-moderate bleeding for which conventional hemostatic methods were impractical or ineffective) were treated with Surgicel®-P. The primary endpoint was the proportion of subjects showing hemostasis at 5 minutes after application, without re-bleeding needing other hemostatic treatment. Secondary endpoints were these proportions at 3 and 10 minutes. The investigators’ ease-of-use evaluation of Surgicel®-P was recorded via questionnaire. Safety endpoints were the incidences of re-bleeding and thromboembolic events through day 30, and serious adverse events requiring surgical intervention through month 6 with a causal (including unlikely or at least possible) relationship to Surgicel®-P. Results. In 8 centers, 103 subjects were enrolled [median(range) age 64.0(33-88) years], of which 100 completed the study. Two deaths occurred, due to causes unrelated to Surgicel®-P. Surgeries were open (53.4%) or laparoscopic/thoracoscopic (46.6%), and mostly urological (37.9%) and abdominal (32.0%); TBSs included various tissue types, with mild (69.9%) or moderate (30.1%) bleeding over a median(range) surface area of 4(0.02–72.0) cm2. The 5-minute hemostatic success rate (primary endpoint) was 87.4%; the 3- and 10-minute rates (secondary endpoints) were 77.7% and 92.2%, respectively. Subgroup analyses showed 3-, 5- and 10-minute rates of 84.7%, 93.1%, 95.8% for mild, versus 61.3%, 74.2%, 83.9% for moderate bleeding, and 80.0%, 90.9%, 96.4% for open versus 75.0%, 83.3%, 87.5% for laparoscopic/thoracoscopic procedures. Within 10 minutes, initial manual compression (27.5%) was progressively abandoned, and additional Surgicel®-P was applied to 17.4% of TBSs. Investigators reverted to suture, cautery or other topical hemostats in 6.8% of procedures. No safety signals were identified. Investigators favorably evaluated the ease of use of Surgicel®-P device. Conclusions. This post-market clinical study supports the safety and efficacy of Surgicel®-P in controlling mild-to-moderate surgical bleeding in a broad range of surgical procedures.Clinical Trial Registration number. NCT03762200, 03/12/2018

IntroductionThe standard treatment of ovarian cancer is the combination of debulking surgery and chemotherapy. There is an ongoing discussion on which treatment is best: primary debulking surgery (PDS) or neoadjuvant chemotherapy with interval debulking (NACT-IDS). Even a large randomized trial has not settled this issue. We examined whether comparing a specified treatment protocol would not be a more logical approach to answer this type of discussions.MethodsA retrospective study of 142 consecutively treated patients according to a fixed protocol between 2000 and 2012 was conducted. Disease-free survival and overall survival were calculated by univariate and multivariate analyses for the whole group and for advanced stages separately. Specific differences between PDS and NACT-IDS were studied. Comparison of results from large databases was made.ResultsDisease-free survival and overall 5-year survival for the whole group were 35% and 50%. For the advanced stages, disease-free survival and overall 5-year survival were 14% and 36%, with a median disease-free and overall survival of 16 and 44 months. Of the 98 women with advanced ovarian carcinoma, 54% of operable patients underwent PDS and 44% underwent NACT-IDS. More patients in the PDS group were optimally (DiscussionOutcome of treatment according to a fixed protocol with a mixture of PDS and NACT-IDS was similar to results from large databases. We hypothesize that comparison of a specific strategy may yield more useful results than awaiting the perfect randomized trial.

Objectives To determine the effect of home-based primary care (HBPC) on Medicare costs and mortality in frail elders. Design Case–control concurrent study using Medicare administrative data. Setting HBPC practice in Washington, District of Columbia. Participants HBPC cases (n = 722) and controls (n = 2,161) matched for sex, age bands, race, Medicare buy-in status (whether Medicaid covers Part B premiums), long-term nursing home status, cognitive impairment, and frailty. Cases were eligible if enrolled in MedStar Washington Hospital Center's HBPC program during 2004 to 2008. Controls were selected from Washington, District of Columbia, and urban counties in Virginia, Maryland, and Pennsylvania. Intervention HBPC clinical service. Measurements Medicare costs, utilization events, mortality. Results Mean age was 83.7 for cases and 82.0 for controls (P

Objective Before the knowledge that 5 years of adjuvant tamoxifen is less efficacious than 2 to 3 years of tamoxifen followed by 2 to 3 years of anastrozole/exemestane, we designed a multicenter double-blind randomized controlled trial in women taking tamoxifen with a thickened endometrium to compare uterine and quality-of-life parameters between those switching to anastrozole and those continuing tamoxifen. Methods Asymptomatic postmenopausal women who took adjuvant tamoxifen for 2 to 3 years for operable breast cancer with a double endometrial thickness greater than 7 mm were randomized to 20 mg tamoxifen or 1 mg anastrozole for the remaining duration, totaling 5 years. Tablets were unrecognizable for drug assignment. The primary endpoints were the differences in double endometrial thickness and uterine volume after 1 year. Uterine and quality-of-life data were analyzed using regression methods, and missing values were handled using multiple imputation. Results Seventy-two women (median age, 60 y) were randomized in five hospitals. Relative to women continuing tamoxifen, women switching to anastrozole experienced a decrease of 53% (95% CI, 41%-63%) in double endometrial thickness and a decrease of 51% (95% CI, 39%-60%) in uterine volume. Vaginal dryness (b = 0.064; 95% CI, 0.016-0.112) and sexual problems (b = 0.054; 95% CI, 0.007-0.102) increased in women taking anastrozole compared with women taking tamoxifen. Treatment arms did not differ regarding withdrawal rate and the experience of (serious) adverse events. Conclusions Despite premature trial closure, our data provided valuable insights. Switching to anastrozole strongly decreased the endometrial thickness and uterine volume but increased sexual disturbances. Safe and effective interventions are needed to alleviate sexual dysfunction.

Objective The study was conducted to identify predictors of oligoamenorrhea at 12 months in levonorgestrel-releasing intrauterine system (LNG-IUS) users. Design A 12-month observational study. Setting Gynecologic outpatient clinic in a large regional hospital in Flanders, Belgium. Population or Sample A total of 150 women who had made an informed decision to use a LNG-IUS either as a method of contraception or to manage menorrhagia. Methods All women were premenopausal and first-time users. The variables recorded prior to insertion on Days 1 to 5 of the menstrual cycle were age, parity, body mass index, indication for LNG-IUS use, prior contraceptive use, menstrual bleeding history, length of the uterine cavity, endometrial thickness, number of antral follicles, serum follicle-stimulating hormone, inhibin B and anti-Mullerian hormone. Menstrual bleeding pattern, patient satisfaction or wish to discontinue the method was noted at 3, 6 and 12 months of follow-up visits. Main Outcome Measures Menstrual bleeding pattern (amenorrhea, oligomenorrhea, menorrhagia) at 12 months was taken as the primary outcome measurement. Patient satisfaction was followed as a secondary outcome. Results Oligoamenorrhea was associated with a high patient satisfaction. A bleeding period less than 5 days, absence of severe uterine bleeding at baseline, LNG-IUS use for contraception and oligoamenorrhea at 3 months were predictors of a favorable outcome at 12 months in a univariate analysis. The absence of severe bleeding prior to LNG-IUS insertion was the only clinically useful predictor of favorable outcome in the multivariate analysis (odds ratio 0.13, 95% confidence interval 0.02–0.66). Conclusions Patient profiling as described is not helpful in counselling women for intentional LNG-IUS use, especially not if it is planned as a method of managing menorrhagia.

This chapter reviews the three major issues relevant to getting started with a home-based medical service. They are (1) defining the clinical and geographic aspects of a target population, (2) how to build a practice and team structure for a defined population, and (3) what are the financial options for long-term sustainability. Building an effective and sustainable home-based medical practice depends on creating a dedicated core team to deliver comprehensive medical and social services focused on avoiding high-cost events, successful integration of community service partners, establishing a strong administrative structure, and a diversified financial model.

The posterior intravaginal sling is a new tension-free needle suspension technique. It is used for the treatment of middle compartment (vaginal vault or uterine) prolapse. The Prolene sling suspends the vagina at the upper border of level II support as described by DeLancey (Am J Obstet Gynecol 166:1717, 1992). Human cadaveric dissections were undertaken to explore the pertinent anatomy that is involved when using this blind needle technique. Pre-dissected cadaveric material was used to obtain didactic illustrations of the anatomy of the procedure. Description of the surgical technique using anatomical landmarks and relative distances of the needle to these landmarks will improve the surgeon's visual understanding of the procedure. The measurements obtained demonstrate that the needle stays at a minimal distance of 4 cm away from the major (pudendal) vessels that could potentially cause life-threatening haemorrhage.

Objectives To evaluate the performance of a first-trimester fetal aneuploidy screening program, with a documented underestimation of nuchal translucency thickness measurements (NT) compared to the Fetal Medicine Foundation (FMF) reference range. Methods We analysed the data of Algemeen Medisch Laboratorium (AML) in Antwerp, Belgium, on combined screening with pregnancy-associated plasma protein-A (PAPP-A), free β-human chorionic gonadotropin (FB-hCG) and NT. NT-multiples of the median (MoM), relative to the FMF reference range, were used for risk calculations. Results The proportion of first-trimester screening tests in the total of serum screening tests increased from 1.3% (125/9424) in 2000 to 53.1% (6577/12 377) in 2003. Only 11.4% (1514/13 267) of NT measurements were performed according to FMF criteria. The 80.8% (21/26) trisomy 21 (T21) detection rate (DR) at cut off 1:300 resulted from maternal serum screening. NT measurements did not add to this DR, but reduced the false-positive rate from 16.8% (2212/13181) to 8.6% (1130/13181). Only 23.8% (5/21) of T21 detections were by FMF trainees. Conclusion Easy access to screening and maternal serum parameters accounted for the majority of T21 detections in our first-trimester combined screening program. Copyright © 2005 John Wiley & Sons, Ltd.

OBJECTIVE: The endometrial origin of uterine carcinosarcoma has recently been well established. The current study investigates whether uterine carcinosarcomas can be included in protocols on high-risk endometrial cancer, given the similarities in biologic behavior of both entities. METHODS: Pathological and surgical notes of patients diagnosed with grade 3 endometrioid, carcinosarcoma, serous and clear cell endometrial cancer subtypes were retrospectively analyzed with special attention to the spread pattern of the different subtypes. Information on site of relapse and time to recurrence was obtained. RESULTS: We traced 146 patients of which 9 patients were ineligible. Histological subtypes of the remaining 137 patients were as follows: 50 (37%) grade 3 endometrioid carcinoma, 54 (39%) serous or clear cell carcinoma (non-endometrioid carcinoma), and 33 (24%) carcinosarcomas. Distribution of early stage disease (I and II) was 67, 46, and 78% for grade 3 endometrioid, non-endometrioid, and carcinosarcoma, respectively. Although we could not trace differences in hematogenic and transperitoneal spread among the three subtypes, non-endometrioid and carcinosarcomas were more likely to spread to pelvic and paraaortic lymph nodes (P

To evaluate maternal serum screening for trisomy 21 (MSS) in Flanders between 1992 and 2002.Data of a large database on the results of MSS, nuchal translucency (NT) and pregnancy outcome were analysed retrospectively.Despite an excellent performance of second trimester MSS at a maternal ageor = 35 years (94.4% detection rate (DR) of trisomy 21 at a false positive rate (FPR) of 22.4%), the proportion of patients above 35 years of age in the study population was significantly lower than in the Flemish general pregnant population (5.5% versus 8.9%, P0.001). In the population screened by MSS and NT, the DR of second trimester MSS at a 5% FPR was 44.4%, which was lower than 66.6% in the population screened by MSS without NT. When nine trisomy 21-affected pregnancies were compared to 3265 normal pregnancies, the mean NT-MoM values were not significantly different (1.16 +/- 0.89 versus 1.00 +/- 0.46, P0.05). Both the findings comply to a sequential screening practice where second trimester MSS is only performed after a normal measurement of NT in the first trimester.In Flanders, the uptake of second trimester maternal serum screening is low in women aged 35 years or more. Its screening performance decreased after the introduction of sequential screening.

Background . Given the paucity of data regarding hormone dependency, it was the purpose of this study to screen for the presence of estrogen and progesterone receptors in uterine adenosarcoma (UAS). Methods . One hundred and five centers were asked to screen their files for uterine adenosarcomas. A immunohistochemical estrogen and progesterone receptor determination was performed. Results . Twenty-eight primary UAS were stained, including one cervical adenosarcoma. Sarcomatous overgrowth could be observed in eight. Furthermore, two cases of recurrent UAS, one only consisting of endometrial stromal sarcoma, were stained. UAS lacking sarcomatous overgrowth showed estrogen receptor positivity in 17/20 (85%) and 16/20 (80%) in the epithelial and sarcomatous component, respectively. Progesterone positivity was observed in 13/20 (65%) and 12/20 (60%) in the epithelial and sarcomatous component, respectively. In 18/20 (90%) of the cases, either the estrogen or the progesterone receptor stained positive in the sarcomatous component. UAS with sarcomatous overgrowth showed estrogen receptor positivity in 4/8 (50%) and 0/8 (0%) in the epithelial and sarcomatous component, respectively. Progesterone positivity was observed in 2/8 (25%) and 1/8 (12%) in the epithelial and sarcomatous component, respectively. The stromal component of both recurrent cases stained moderately positive for estrogen receptor whereas progesterone receptor was considered negative. Conclusion . The observation that the sarcomatous component of UAS without sarcomatous overgrowth frequently expresses hormone receptors might be of significant clinical importance.

Single-step maternal serum screening (MSS) in the first (1MSS) or second (2MSS) trimester at maternal age ≧35 years was evaluated in the North Belgian region Flanders, where difficulties are encountered in the general introduction of combined or integrated screening algorithms. The fetal aneuploidy screening database of General Medical Laboratory AML in Antwerp was searched for 2MSS tests between 1992 and 1999 (α-fetoprotein, β-human chorionic gonadotropin (β-HCG) and unconjugated estriol, cut-off 1:300) and for 1MSS tests between 1999 and 2003 (free β-HCG and pregnancy-associated plasma protein A, cut-off 1:85). At ≧35 years, the detection rate for trisomy 21 (DR) was 93.8% (15/16) for 2MSS and the screen-positive rate (SPR) was 24.5% (504/2061). For 1MSS, these figures were 85.7% (6/7) and 17.7% (109/615) respectively. To detect one trisomy 21, missed by MSS at ≧35 years of age, an additional number of 1,557 and 506 primary invasive procedures would be needed for 2MMS and 1MSS respectively. We conclude that the performance of bothsingle-step 1MSS and 2MSS at maternal age ≧35 years in Flanders is excellent, even without the combination with ultrasound parameters or integration of first and second trimester parameters. The simplicity of both methods allows to consider them valuable options for fetal aneuploidy screening at advanced maternal age, until high quality combined or integrated screening is accessible to all pregnant women in Belgium.

Summary: A 65-year-old black woman was found to have a 3.0 cm endometrial tumor that was a carcinosarcoma with a major epithelial and a less prominent mesenchymal component. The latter was undifferentiated but one focus of chondroid differentiation was noted. The former showed papillary serous differentiation. Melanin pigment was observed in both epithelial and mesenchymal components. Staining with antisera to S100 protein and HMB-45 confirmed the presence of melanocytes. An endocervical focus of tumor also contained melanin. Electron-microscopic studies showed large tumor cells with an irregularly indented nucleus and abnormal giant cytoplasmic melanosomes. Only one case of uterine carcinosarcoma with melanocytic differentiation has been previously reported.

Incarceration of the gravid uterus is a rare obstetric disorder that is often not recognized despite the ready availability of ultrasound. However, detailed imaging of the disturbed uterine and pelvic anatomy - from an obstetric point of view- is the key in reducing the potentially severe complications of this condition and planning its treatment. In this paper, we will describe the specific magnetic resonance imaging (MRI) features of an incarceration of the gravid uterus and we will discuss the role of magnetic resonance imaging in defining anatomy and in the medical decision whether to operate or not.

Aim: To determine how accurately and confidently examiners with different levels of ultrasound experience can classify adnexal masses as benign or malignant and suggest a specific histological diagnosis when evaluating ultrasound images using pattern recognition. Methods: Ultrasound images of selected adnexal masses were evaluated by 3 expert sonologists, 2 senior and 4 junior trainees. They were instructed to classify the masses using pattern recognition as benign or malignant, to state the level of confidence with which this classification was made and to suggest a specific histological diagnosis. Sensitivity, specificity, accuracy and positive and negative likelihood ratios (LR+ and LR–) with regard to malignancy were calculated. The area under the receiver operating characteristic curve (AUC) of pattern recognition was calculated by using six levels of diagnostic confidence. Results: 166 masses were examined, of which 42% were malignant. Sensitivity with regard to malignancy ranged from 80 to 86% for the experts, was 70 and 84% for the 2 senior trainees and ranged from 70 to 86% for the junior trainees. The specificity of the experts ranged from 79 to 91%, was 77 and 89% for the senior trainees and ranged from 59 to 83% for the junior trainees. The experts were uncertain about their diagnosis in 4–13% of the cases, the senior trainees in 15–20% and the junior trainees in 67–100% of the cases. The AUCs ranged from 0.861 to 0.922 for the experts, were 0.842 and 0.855 for the senior trainees, and ranged from 0.726 to 0.795 for the junior trainees. The experts suggested a correct specific histological diagnosis in 69–77% of the cases. All 6 trainees did so significantly less often (22–42% of the cases). Conclusion: Expert sonologists can accurately classify adnexal masses as benign or malignant and can successfully predict the specific histological diagnosis in many cases. Whilst less experienced operators perform reasonably well when predicting the benign or malignant nature of the mass, they do so with a very low level of diagnostic confidence and are unable to state the likely histology of a mass in most cases.

An experimental surgical study on human cadavers was undertaken to assess variability in the trajectory followed by the needle during application of the inside-out transobturator tape suspension (TVT-O) technique. The TVT-O surgical procedures were performed on six fresh female cadavers according to the standard recommended operative protocol. Subsequent anatomical dissection revealed that the needle had perforated the obturator membrane at a distance of 0.7 to 2.0 cm from the needle to the obturator canal. It subsequently followed a variable course passing at 0.5 to 2.0 cm from the anterior branch of the obturator nerve and 0.1 to 1.4 cm from the posterior branch. We conclude from this anatomical study that the TVT-O trajectory is subject to wider variability than was originally postulated.

This is the first report of an intrauterine pregnancy following timed coitus, resulting from transperitoneal sperm and/or oocyte migration as the oocyte originated from an ectopic (undescended) ovary. The patient was treated in the infertility clinic after a history of primary infertility for 2 years. Diagnosis of a moderate teratozoospermia and the presence of a unicornuate uterus with one right-sided normal ovary was made. During the first intrauterine insemination (IUI) treatment cycle with clomiphene citrate stimulation, a discrepancy between oestradiol concentrations and follicular growth was observed. Magnetic resonance imaging (MRI) was carried out because the presence of an ectopic ovary was suspected. The diagnosis of a left-sided undescended ovary was made, containing several follicles, the largest measuring 16 mm in diameter. Because of a spontaneous LH surge 2 days later without substantial follicular growth in the normal right-sided ovary, IUI was cancelled and timed intercourse was planned. Surprisingly, and although the largest follicle in the normally located ovary reached a maximum diameter of only 12 mm on repetitive ultrasound monitoring, this patient became pregnant and gave birth to a healthy baby boy.

The Washington Hospital Center initiated a geriatric medical and house call service for its local elderly population. Preliminary data shows that ER visits have been reduced by about 30 percent and admissions reduced by 10 percent, compared to the same patients in the year before enrollment. In most cases, the medical care is more effective, less costly, and more accessible for both the family and the health care system.

We describe two patients who were coinfected with human immunodeficiency virus (HIV) and human T-cell lymphotropic virus (HTLV) type I. They had clinical evidence of immunodeficiency (anergy, oral candidiasis, and disseminated herpes zoster) despite having elevated CD4 T lymphocyte counts (range, 2,450-5,292/mm 3 ). We conclude that CD4 lymphocyte counts may not be reliable markers of immunologic competence in patients coinfected with HIV and HTLV-I.

To the Editor: Ectopic ovaries are characterized by their attachment to an area above the level of the common iliac vessels.1 Although they may occur in women with a normal uterus, the incidence is reported to be as high as 20 percent when the uterus is absent and 42 percent in cases of a unicornuate uterus.2 Despite the well-known association of ectopic ovaries and a unicornuate uterus, ectopic ovaries are reported only sporadically, suggesting the possibility that many cases go unrecognized.3–5 We report two cases in which an ectopic ovary was detected in association with a unicornuate uterus. A . . .