Manual morcellation (Resectr (TM) 9Fr) versus electromechanical morcellation (TruClear (TM)) for hysteroscopic polypectomy : a randomized controlled non-inferiority trial

IntroductionMeta-analyses comparing hysteroscopic electromechanical morcellation with electrosurgical resection showed a shorter operating time for electromechanical morcellation, mainly for polypectomy. The Resectr (TM) 9Fr is a new hysteroscopic manual morcellator, designed to simplify this procedure. We aimed to compare manual with electromechanical morcellation for hysteroscopic polypectomy. Material and methodsThis two-center randomized controlled non-inferiority trial was performed from 2018 to 2021 in the Catharina Hospital and the Ghent University Hospital. The study was registered at the Dutch Trial Register (NL6922; ICTRP ID: NTR7118). One hundred and forty women with polyps (between 8 and 20 mm) scheduled for hysteroscopic removal were randomized between manual (Resectr (TM) 9Fr) or electromechanical (TruClear (TM)) morcellation. The primary outcome was time (instrumentation set-up, resection, and total procedure time). ResultsThe non-inferiority margin for the primary outcome time was 1.3. Mean instrumentation set-up time was 10% shorter with the manual compared with the electromechanical morcellator (estimated mean ratio manual/electromechanical = 0.9; 97.5% confidence interval [CI] 0.8-1.1). Mean resection time was 30% longer with the manual compared with the motor-driven system (estimated mean ratio manual/electromechanical = 1.3; 97.5% CI 0.9-1.9). Mean total procedure time was 10% longer with the manual compared with the electromechanical morcellator (estimated mean ratio manual/electromechanical = 1.1; 95% CI 0.91-1.298). The estimated odds (electromechanical/manual) of better surgeon's safety, effective and comfort scores were, respectively, 4.5 (95% CI 0.9-22.1), 7.0 (95% CI 1.5-31.9), and 5.9 (95% CI 1.1-30.3) times higher with the motor-driven compared with the manual morcellator. Conversion rates and incomplete resection rates were comparable in both groups (manual versus electromechanical) (7.6% [4/66] vs. 2.9% [2/68] and 6.1% [4/66] vs. 3.0% [2/66], respectively). No intraoperative and postoperative complications were registered. ConclusionsThe manual morcellator was non-inferior to the electromechanical morcellator for hysteroscopic polypectomy in terms of mean instrumentation set-up time and total procedure time. Results on resection time were inconclusive. Conversion and incomplete resection rates were within the range reported in the literature. Surgeon's reported rating for both devices was high, however, in favor of the motor-driven tissue removal system

Reproductive and obstetric outcomes after hysteroscopic removal of retained products of conception

Study Objective: To evaluate the reproductive outcomes in women treated for retained products of conception (RPOC) by hysteroscopy (morcellation vs loop resection). Design: Cohort study. Setting: A teaching and university hospital. Patients: Patients included in a previous randomized controlled trial on hysteroscopic removal of RPOC comparing morcellation (n = 46) with loop resection (n = 40). Interventions: Hysteroscopic morcellation versus loop resection. Measurements and Main Results: The primary outcome measures were live birth and pregnancy complications (including abnormal placentation [placenta accreta/increta/percreta], placenta previa, vasa previa, retained placenta after delivery or incomplete expulsion with the need for manual removal or curettage, and RPOC), uterine rupture, and other complications (blood loss, preterm labor, preterm premature rupture of membranes, hypertensive disorders of pregnancy, and intrauterine growth restriction). The live birth rate was 88.9% in the morcellation group and 68.2% in the loop resection group (p = .09). Uterine rupture occurred in 1 patient in the morcellation group (4.2%) (p = 1.00). Placental complications were found in 20.8% and 22.2% of the hysteroscopic morcellation and loop resection groups, respectively (p = .33), and other pregnancy complications were seen in 33.3% and 16.6% of the 2 groups (p = .33). The secondary outcome was time to pregnancy. The median time to pregnancy was 14 weeks (interquartile range [IQR], 5-33 weeks) in the morcellation group and 15 weeks (IQR, 6-37 weeks) in the loop resection group (p = .96). Conclusion: Hysteroscopic removal of RPOC seems to have no detrimental effect on reproductive outcome and no significant effect on pregnancy rate. (C) 2019 AAGL. All rights reserved

MRI markers of adenomyosis severity associated with worse IVF/ICSI outcomes

Study objective: The aim of this study was to characterise the severity of adenomyosis on MRI in infertile women, and to assess if MRI characteristics of adenomyosis severity are associated with worse IVF/ICSI pregnancy outcomes versus male infertility controls. Materials and methods: This single-centre retrospective study was carried out at Catharina Hospital in Eindhoven, The Netherlands. The MRIs of 124 infertile women undergoing their first, fresh embryo transfer during IVF/ICSI, diagnosed with adenomyosis only (N = 31), or combined adenomyosis and endometriosis (N = 93) were assessed. Measurements of MRI adenomyosis features were performed by two independent investigators. IVF/ICSI outcomes (biochemical pregnancy (BP), ongoing pregnancy (OP) and live birth (LB)) of adenomyosis patients were compared to those of 889 male infertility controls. Results: Patients with adenomyosis had significantly worse IVF/ICSI outcomes compared to male infertility controls. When assessing individual MRI parameters, adenomyosis patients with a mean junctional zone (JZ) of &gt;12 mm, a JZ/Myometrium ratio of &gt;40%, presence of myometrial cysts and presence of endometriosis (specifically deep invasive endometriosis(DIE)) showed statistically significantly worse outcomes compared to patients with milder disease. Conclusion: The results of this retrospective study suggest that individual MRI markers for severe adenomyosis (mean JZ &gt; 12 mm, myometrial cysts), especially when combined with (severe) endometriosis, may be associated with fewer pregnancies during IVF/ICSI when compared to male infertility controls. Future prospective studies should investigate the prognostic potential of these markers for prediction of IVF/ICSI success.</p

Noninvasive, accurate assessment of the behavior of representative populations of motor units in targeted reinnervated muscles

Targeted muscle reinnervation (TMR) redirects nerves that have lost their target, due to amputation, to remaining muscles in the region of the stump with the intent of establishing intuitive myosignals to control a complex prosthetic device. In order to directly recover the neural code underlying an attempted limb movement, in this paper, we present the decomposition of high-density surface electromyographic (EMG) signals detected from three TMR patients into the individual motor unit spike trains. The aim was to prove, for the first time, the feasibility of decoding the neural drive that would reach muscles of the missing limb in TMR patients, to show the accuracy of the decoding, and to demonstrate the representativeness of the pool of extracted motor units. Six to seven flexible EMG electrode grids of 64 electrodes each were mounted over the reinnervated muscles of each patient, resulting in up to 448 EMG signals. The subjects were asked to attempt elbow extension and flexion, hand open and close, wrist extension and flexion, wrist pronation and supination, of their missing limb. The EMG signals were decomposed using the Convolution Kernel Compensation technique and the decomposition accuracy was evaluated with a signal-based index of accuracy, called pulse-to-noise ratio (PNR). The results showed that the spike trains of 3 to 27 motor units could be identified for each task, with a sensitivity of the decomposition > 90%, as revealed by PNR. The motor unit discharge rates were within physiological values of normally innervated muscles. Moreover, the detected motor units showed a high degree of common drive so that the set of extracted units per task was representative of the behavior of the population of active units. The results open a path for a new generation of human-machine interfaces in which the control signals are extracted from noninvasive recordings and the obtained neural information is based directly on the spike trains of motor neurons

Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close): multicentre, double-blind, randomised controlled superiority trial

Objective To evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar. Design Multicentre, double-blind, randomised controlled superiority trial. Setting Thirty-two hospitals in the Netherlands. Population A total of 2292 women aged >= 18 years undergoing a first CS were randomly assigned to each procedure (1:1): 1144 women were assigned to single-layer uterine closure and 1148 women were assigned to double-layer uterine closure. Methods Single-layer unlocked closure and double-layer unlocked closure, with the second layer imbricating the first. Main outcome measures Number of days with postmenstrual spotting during one menstrual cycle 9 months after CS. Secondary outcomes: perioperative and menstrual characteristics; transvaginal ultrasound measurements. Results A total of 774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome, as a result of drop-out and amenorrhoea. The mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12-1.54) after single-layer closure and 1.26 (bootstrapped 95% CI 1.07-1.45) after double-layer closure (adjusted mean difference -0.07, 95% CI -0.37 to 0.22, P = 0.810). The operative time was 3.9 minutes longer (95% CI 3.0-4.9 minutes, P < 0.001) and niche prevalence was 4.7% higher (95% CI 0.7-8.7%, P = 0.022) after double-layer closure. Conclusions The superiority of double-layer closure compared with single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted. Tweetable abstract Double-layer uterine closure is not superior for postmenstrual spotting after a first caesarean; single-layer closure performs slightly better on other outcomes

Septum resection versus expectant management in women with a septate uterus : an international multicentre open-label randomised controlled trial

STUDY QUESTION: Does septum resection improve reproductive outcomes in women with a septate uterus? SUMMARY ANSWER: Hysteroscopic septum resection does not improve reproductive outcomes in women with a septate uterus. WHAT IS KNOWN ALREADY: A septate uterus is a congenital uterine anomaly. Women with a septate uterus are at increased risk of subfertility, pregnancy loss and preterm birth. Hysteroscopic resection of a septum may improve the chance of a live birth in affected women, but this has never been evaluated in randomized clinical trials. We assessed whether septum resection improves reproductive outcomes in women with a septate uterus, wanting to become pregnant. STUDY DESIGN, SIZE, DURATION: We performed an international, multicentre, open-label, randomized controlled trial in 10 centres in The Netherlands, UK, USA and Iran between October 2010 and September 2018. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with a septate uterus and a history of subfertility, pregnancy loss or preterm birth were randomly allocated to septum resection or expectant management. The primary outcome was conception leading to live birth within 12 months after randomization, defined as the birth of a living foetus beyond 24 weeks of gestational age. We analysed the data on an intention-to-treat basis and calculated relative risks with 95% CI. MAIN RESULTS AND THE ROLE OF CHANCE: We randomly assigned 80 women with a septate uterus to septum resection (n = 40) or expectant management (n = 40). We excluded one woman who underwent septum resection from the intention-to-treat analysis, because she withdrew informed consent for the study shortly after randomization. Live birth occurred in 12 of 39 women allocated to septum resection (31%) and in 14 of 40 women allocated to expectant management (35%) (relative risk (RR) 0.88 (95% CI 0.47 to 1.65)). There was one uterine perforation which occurred during surgery (1/39 = 2.6%). LIMITATIONS, REASONS FOR CAUTION: Although this was a major international trial, the sample size was still limited and recruitment took a long period. Since surgical techniques did not fundamentally change over time, we consider the latter of limited clinical significance. WIDER IMPLICATIONS OF THE FINDINGS: The trial generated high-level evidence in addition to evidence from a recently published large cohort study. Both studies unequivocally do not reveal any improvements in reproductive outcomes, thereby questioning any rationale behind surgery

Prognostic model on niche development after a first caesarean section:development and internal validation

Objective: To develop and internally validate a prognostic prediction model for development of a niche in the uterine scar after a first caesarean section (CS). Study design: Secondary analyses on data of a randomized controlled trial, performed in 32 hospitals in the Netherlands among women undergoing a first caesarean section. We used multivariable backward logistic regression. Missing data were handled using multiple imputation. Model performance was assessed by calibration and discrimination. Internal validation using bootstrapping techniques took place. The outcome was ‘development of a niche in the uterus’, defined as an indentation of = 2 mm in the myometrium. Results: We developed two models to predict niche development: in the total population and after elective CS. Patient related risk factors were: gestational age, twin pregnancy and smoking, and surgery related risk factors were double-layer closure and less surgical experience. Multiparity and Vicryl suture material were protective factors. The prediction model in women undergoing elective CS revealed similar results. After internal validation, Nagelkerke R2 ranged from 0.01 to 0.05 and was considered low; median area under the curve (AUC) ranged from 0.56 to 0.62, indicating failed to poor discriminative ability. Conclusions: The model cannot be used to accurately predict the development of a niche after a first CS. However, several factors seem to influence scar healing which indicates possibilities for future prevention such as surgical experience and suture material. The search for additional risk factors that play a role in development of a niche should be continued to improve the discriminative ability