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Recurrence rate after hysteroscopic adhesiolysis can be as high as 60%. This RCT aimed to assess the effectiveness of a new intrauterine mechanical barrier film in the management of IUA. PREG2 is a double-blind randomized, controlled, stratified study. 16 sites in Europe and China. Patients scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate adhesions (AFS score ≥ 5). Following adhesiolysis, patients were randomized to either have a Womed Leaf film inserted or not. Womed Leaf (Womed SAS, France) is a degradable polymer film that expands to fill the entire cavity and acts as a mechanical barrier between the uterine walls. After about a week, it degrades and is discharged naturally. Hormonal treatment was authorized in both groups. Patients were scheduled for second-look hysteroscopy (SLH) after 4 to 8 weeks. The effectiveness endpoints were: Change in AFS score between baseline and SLH, responder rate (i.e. patients who improved of at least two clinical categories, e.g. from severe to mild or from moderate to no IUA) and absence of IUA at SLH. The patient and the SLH evaluator were blind. 160 women were randomized. The reduction in AFS score at SLH was significantly higher in the intervention compared to the control group (5.2 ± 2.8 vs. 4.2 ± 3.2; p=0.0153). The responder rate was significantly higher in the intervention group (51% vs 29% OR 2.7 [1.4–5.5]; p=0.0052). The absence of adhesions at SLH was significantly higher in the intervention group (41% vs 24% OR 2.44 [CI 1.161 - 5.116]; p=0.0189). None of the reported adverse events were serious or considered related to the device. This large RCT of patients with severe or moderate IUA demonstrated the effectiveness of Womed Leaf. It is the first adhesion barrier to show any clinically meaningful improvement in this challenging indication. [ABSTRACT FROM AUTHOR]

Background and Aims: As a modifiable lifestyle factor, diet is hypothesized to play an important role in the progression of atherosclerosis. The aim of this study was to explore associations of comprehensive dietary patterns derived by cluster analysis with degree and progression of coronary artery calcification (CAC) over five years of follow-up.Methods and Results: In the population-based Heinz Nixdorf Recall study, 3718 participants (45-75 years; 47.6% men) without coronary heart disease completed a food frequency questionnaire at baseline. Five distinct dietary patterns were identified using cluster analysis: "Health-conscious", "Traditional German/Less alcohol", "Mediterranean-like", "Western" and "Animal fat/Alcohol" (used as reference). CAC was measured using electron-beam computed tomography at baseline and five years later. CAC after five years was predicted based on sex- and age-specific baseline percentiles. After comparing observed and predicted CAC Scores, CAC progression was classified as slow, expected, or rapid. Compared to "Animal fat/Alcohol" diet, a "Mediterranean-like" diet was associated with a relative risk (RR) for a rapid CAC progression in both sexes (men: 0.61; 95%-confidence interval [95%-CI]: 0.41; 0.90; women: 0.59; 95%-CI: 0.45; 0.78). Furthermore, reduced RRs were observed in women with a "Health-conscious" and a "Traditional German/Less alcohol" diet (0.63; 95%-CI: 0.47; 0.84, respectively 0.69; 95%-CI: 0.52; 0.90). No association was observed for a "Western" diet for both sexes. Similar results were revealed for degree of CAC.Conclusion: The study results support the hypothesis that a "Mediterranean-like" diet is associated with a lower CAC-progression and lower degree of CAC in men and women. [ABSTRACT FROM AUTHOR]

The objective of this first-in-human study was to evaluate the safety of the novel intrauterine adhesion barrier film Womed LeafTM and pilot its potential efficacy in preventing IUAs after hysteroscopic myomectomy. PREG1 is a prospective, multi-center, international, single arm clinical study. Womed LeafTM (Womed SAS, France) is a degradable polymer film (DPF) designed for insertion into the uterus like an IUD, that self-expands to fill the cavity and separate the uterine walls. After approximately one week, it degrades to be naturally discharged through the cervix. The safety endpoint was the number of device-related Adverse Events (AE) at thirty days, and the efficacy endpoint was freedom from IUA at second look hysteroscopy at six weeks. N/A. 23 women over 40 years with no plans to conceive who qualified for transcervical resection of myoma (TCRM), with at least one 10=millimeter type 0, 1 or 2 myoma, were enrolled between December 2019 and January 2021, from six centers in France, Belgium and the Netherlands. Women underwent TCRM, immediately followed by DPF insertion and ultrasound verification. The device was successfully delivered on first attempt in all cases and the procedure was rated as easy by all operators. The DPF was visible by ultrasound in 22/23 women (96%). There were no device-related AE. Of the 23 women, 13 noticed the DPF discharge 6 days on average after surgery, with a discomfort level of 1.9 on a scale of 10. At second look hysteroscopy, 20 of the 23 women (87%) were free of IUAs, and no residual DPF was found in the uterine cavity. Womed LeafTM, the first mechanical barrier specifically designed to prevent IUA, is a novel, safe, easy to apply device with very promising initial efficacy data. [ABSTRACT FROM AUTHOR]

Summary Introduction Failure of kidney migration during embryonic life results in an ectopic kidney, with an incidence varying from 1 in 500 to 1 in 1200. Pelvic kidney can be a rare cause of recurrent urinary tract infection (UTI), warranting nephrectomy in some cases. Material and methods A 7-year-old girl with a history of recurrent UTIs and vaginal discharge was diagnosed with a dysplastic afunctional ectopic kidney located in the pelvis, with ureter draining into the cervix or vaginal wall. Results A robot-assisted approach was chosen, with side docking of the robot to allow concurrent vaginoscopic/hysteroscopic exploration. A uterus bicornis was found. The ectopic ureter was dissected toward its drainage in the vaginal wall, where it was sutured and resected. The dysplastic kidney and ureter were removed. Compared to pure laparoscopic approach, dissection deep into the pelvis toward the vaginal wall is aided by the robotic dexterity and facilitates complete resection of the structure, which avoids leaving a ureteric stump into the vaginal wall. Conclusions Robot-assisted surgery is a safe and effective option for resection of ectopic kidneys with ectopic ureter in children. Dissection up until the vaginal wall in children is aided by robotic dexterity, making this kind of surgery the ideal indication for robotic-assisted surgery. [ABSTRACT FROM AUTHOR]

External validation of previously presented prediction models to help counsel patients for failure of endometrial ablation (EA) or surgical re-intervention within 2 years after EA. Retrospective cohort study, minimal follow-up time of 2 years. Data from Medisch Spectrum Twente, Enschede and Ziekenhuisgroep Twente, Almelo/Hengelo, both non-university teaching hospitals in the Netherlands, were used for external validation. Premenopausal women (18+) who had an EA for complaints of heavy menstrual bleeding between January 2010 & November 2012. A total number of 329 patients were eligible for analysis. Novasure (Hologic, Marlborough, MA) and ThermaChoice III (Ethicon, Sommerville, NJ). Both interventions had the same outcomes according to the literature. Data-analysis was done by using IBM SPSS statistics software version 21.0 (IBM Corp., Armonk, NY). Final results showed an area under the curve (AUC) of 0.59 for the outcome of failure within 2 years. Variables in this model were dysmenorrhea, low age, parity ≥5 and preoperative menorrhagia. The AUC for the outcome of surgical re-intervention within 2 years was 0.45. Variables in this model were dysmenorrhea, low age, menstrual duration> 7 days, parity ≥5 and a previous caesarean section. In both models the Hosmer-Lemeshow showed no significant difference between the observed and predicted outcome. The failure-model can be used to predict the outcome of EA within two years. This model can contribute to improve shared decision-making regarding EA in the general population. The re-intervention model appeared to be not useful after external validation, but can still be used in our hospital, because of previous internal validation. We're working on a big data model that is able to support this most personalized form of patient counseling, so that both prediction models can be used in the general population. Furthermore, we're investigating the influence of prediction-outcomes on the decision-making of both the patient and doctor. [ABSTRACT FROM AUTHOR]