The Normal Fetal Heart Rate Study: Analysis Plan

Recording of fetal heart rate via CTG monitoring has been routinely performed as an important part of antenatal and subpartum care for several decades. The current guidelines of the FIGO (ref1) recommend a normal range of the fetal heart rate from 110 to 150 bpm. However, there is no agreement in the medical community whether this is the correct range (ref2). We aim to address this question by computerized analysis (ref 3) of a high quality database (HQDb, ref 4) of about one billion electronically registered fetal heart rate measurements from about 10,000 pregnancies in three medical centres over seven years. In the present paper, we lay out a detailed analysis plan for this evidence-based project in the vein of the validation policy of the Sylvia Lawry Centre for Multiple Sclerosis Research (ref 5) with a split of the database into an exploratory part and a part reserved for validation. We will perform the analysis and the validation after publication of this plan in order to reduce the probability of publishing false positive research findings (ref 6-7)

Transcervical intrauterine radiofrequency ablation of fibroids in high-risk patients with bleeding disorder

Objectives: To show the advantages of transcervical radiofrequency ablation (TRFA) in high-risk patients with bleeding disorder. Material and methods: It is a retrospective analysis. The study included only patients with known pre-existing conditions (obesity, cardiac and neurological disease, coagulation disorder, anaemia) or post-surgical conditions who were treated with the Sonata® System for fibroid-related bleeding complaints at Academic Hospital Cologne Weyertal between January 2015 and March 2021. These patients were classified as high-risk patients. The fibroids were mostly determined due transvaginal sonography. Thirty patients were included, and 43 fibroids were determined. Results: Therapy with the Sonata® system could be performed without complications in all cases. In our analysis, improvement of fibroid-related symptoms was observed in 89% of cases. Conclusions: The Sonata® System is on the one hand minimally invasive, uncomplicated and fast and on the other hand a successful method of fibroid therapy, which is particularly suitable for high-risk patients with various pre-existing conditions, for whom a minimally invasive, bloodless and short surgical procedure has great advantages

Fetal short time variation during labor: a non-invasive alternative to fetal scalp pH measurements?

Objective: To determine whether short time variation (STV) of fetal heart beat correlates with scalp pH measurements during labor. Patients and methods: From 1279 deliveries, 197 women had at least one fetal scalp pH measurement. Using the CTG-Player®, STVs were calculated from the electronically saved cardiotocography (CTG) traces and related to the fetal scalp pH measurements. Results: There was no correlation between STV and fetal scalp pH measurements (r=−0.0592). Conclusions: Fetal STV is an important parameter with high sensitivity for antenatal fetal acidosis. This study shows that STV calculations do not correlate with fetal scalp pH measurements during labor, hence are not helpful in identifying fetal acidosis.Peer Reviewe

Prospective International Multicenter Pelvic Floor Study:Short-Term Follow-Up and Clinical Findings for Combined Pectopexy and Native Tissue Repair

Efforts to use traditional native tissue strategies and reduce the use of meshes have been made in several countries. Combining native tissue repair with sufficient mesh applied apical repair might provide a means of effective treatment. The study group did perform and publish a randomized trial focusing on the combination of traditional native tissue repair with pectopexy or sacrocolpopexy and observed no severe or hitherto unknown risks for patients (Noé G.K. J Endourol 2015;29(2):210–215). The short-term follow-up of this international multicenter study carried out now is presented in this article. Material and Methods: Eleven clinics and 13 surgeons in four European counties participated in the trial. In order to ensure a standardized approach and obtain comparable data, all surgeons were obliged to follow a standardized approach for pectopexy, focusing on the area of fixation and the use of a prefabricated mesh (PVDF PRP 3 × 15 Dynamesh). The mesh was solely used for apical repair. All other clinically relevant defects were treated with native tissue repair. Colposuspension or TVT were used for the treatment of incontinence. Data were collected independently for 14 months on a secured server; 501 surgeries were registered and evaluated. Two hundred and sixty-four patients out of 479 (55.1%) returned for the physical examination and interview after 12–18 months. Main Outcome and Results: The mean duration of follow-up was 15 months. The overall success of apical repair was rated positively by 96.9%, and the satisfaction score was rated positively by 95.5%. A positive general recommendation was expressed by 95.1% of patients. Pelvic pressure was reduced in 95.2%, pain in 98.0%, and urgency in 86.0% of patients. No major complications, mesh exposure, or mesh complication occurred during the follow-up period. Conclusion: In clinical routine, pectopexy and concomitant surgery, mainly using native tissue approaches, resulted in high satisfaction rates and favorable clinical findings. The procedure may also be recommended for use by general urogynecological practitioners with experience in laparoscopy

Atmung und Lokomotion bei Patienten mit Morbus Parkinson und Gesunden

Die Atmung ist wie die Lokomotion bei Patienten mit M. Parkinson gestört. Bei 10 Patienten mit MP und bei 6 gesunden Probanden wurde die Koordination von Atmung und Lokomotion untersucht. Die Lokomotion wurde mittels Piezo-Kristallen aufgezeichnet. Die Atmung wurde durch die respiratorische Induktionsplethymographie ermittelt. Nach der Messung wurde der Grad der Koordination als der Anteil der Auftritte bezeichnet, die innerhalb von 12/50 bins des Atemzyklus erfolgten. Der Grad der Koordination ist bei den Patienten mit MP signifikant niedriger als bei gesunden Probanden. 3 Probanden zeigten ein Verhältnis zwischen Lokomotion und Atmung von 2:1, die anderen 3 Probanden zeigten ein Verhältnis von 3:2. Bei 2 Patienten mit MP, die am geringsten von der Erkrankung betroffen waren, zeigte sich ein 4:1 und ein 3:1 Verhältnis mit einer größeren Streuung als in der gesunden Kontrollgruppe. Die übrigen 8 Patienten zeigten eine diffuse Streuung der Auftritte über den gesamten Atemzyklus

Laparoscopic Isthmocele (Niche) Correction as prevention in patients with fertility desire

Objectives: To report the technique of Laparoscopic Isthmocele (Niche) Correction and surgical outcomes. Material and methods: The retrospective study included only patients with current or potential fertility desire who had laparoscopic surgery for an isthmocele at the Academic Hospital Cologne Weyertal between the beginning of 2014 and the end of 2020. A total of 28 patients were included. Sonographic follow-up of myometrial thickness was performed in 67% cases. Results: In 18% cases myometrial thickness was 5–7 mm, in 11% cases > 7–10 mm and in 39% cases > 10 mm. In the group with postoperative myometrium of 5–7 mm, two patients had preoperative residual myometrium of 2 mm, one patient of 2.5 mm and in one patient residual myometrium was not measurable (< 1 mm). In 11 patients, the postoperative myometrium was either greater than 10 mm and/or no isthmoceles were detectable. There was an increase in mean preoperative myometrial thickness from 2 mm to a mean myometrial thickness of 8.7 mm (myometrial thickness increase to 335%). Conclusions: In this study, laparoscopic correction of the isthmocele resulted in an increase in myometrial thickness from 2 mm to 8.7 mm (average values). This represents an increase in myometrial thickness of 335%. According to the literature review performed and based on our own results, we recommend prophylactic isthmoceles correction in patients with fertility desire by means of laparoscopic procedure. Laparotomy should be performed only in special cases. Surgical hysteroscopy is not suitable for this purpose, but sufficient studies are still lacking.

Are double-J stents in surgery for deep infiltrating endometriosis always necessary? A retrospective analysis

Introduction: The therapy of deep infiltrating endometriosis places the highest demands. Double-J (DJ) stent inser-tion is recommended preoperatively. However, we could not find any publication in PubMed that showed the relevant advantages of double-J stent insertion in surgery of deep infiltrating endometriosis (DIE). Aim: To report the advantages and disadvantages of inserting double-J stents in surgery for deep infiltrating endo-metriosis. Material and methods: All patients who underwent surgery for deep infiltrating endometriosis at Academic Hos-pital Cologne Weyertal (a level III endometriosis center with up to approximately 900 endometriosis laparoscopic procedures annually) between January 2017 and September 2021 were included in this retrospective analysis. A total of 197 cases were included. The urinary tract complications were analyzed and they were divided into infections, pyelonephritis, urosepsis, intraoperative and postoperative ureteral lesions. Patients were divided into three groups: 1) with DJ stents in whom DJ stents were left in place postoperatively for at least 2 weeks, 2) with DJ stents in whom DJ stents were removed directly at the end of the surgery, 3) without DJ stents. Results: There was a significant difference between all three groups in urinary tract complications: group 1 - 32%, group 2 - 11.6% and group 3 - 7%. The p-value of 0.01 shows statistical significance between group with DJ stents and the group without DJ stents. Urinary tract infection occurred in 25.5% in the first group, 11.6% in the second group and 3.6% in the third group. Here, too, the p-value shows statistical significance between the group with DJ stents and the group without DJ stents. Ureteral injury, on the other hand, occurred rarely and no statistically signif-icant difference was found between group 3 and the total population, 3.6% versus 2.5%. In group 1, the injury rate was minimally higher, 6.4%. After comparing groups 1 and 2 with group 3, there was also no significant difference in ureter injury (6.4% vs. 3.6%, p = 0.42). Conclusions: The authors of this study recommend that DJ stent insertion should not be part of the general preop-erative preparation

Combined procedure of the transcervical radiofrequency ablation (TRFA) system and surgical hysteroscopy. Increased risk or safe procedure?

Introduction: The advantage of transcervical radiofrequency ablation (TRFA) is that it is minimally invasive, inci-sion-free, and treats a wide spectrum of fibroids, including those that are not accessible by surgical hysteroscopy (FIGO 3, 4, 5, 6, and 2-5). However, there are no publications describing a combined procedure of operative hysteros-copy and TRFA yet, so it was still unknown whether a combined procedure is associated with additional risks. Aim: To report the combined technique of transcervical intrauterine radiofrequency ablation of fibroids and surgical hysteroscopy. Material and methods: Our study was designed to show the results of our case series with 21 patients. The retro-spective study included only patients who were treated with the combined procedure of surgical hysteroscopy with fibroid and/or endometrial resection and fibroid ablation using the Sonata System. Results: The combined procedure was performed without any complications in all cases. Two days after surgery, no in-creased morbidity was observed compared to only conventional surgical hysteroscopy and/or therapy with the TRFA. All patients were satisfied with the procedure. No late complications were observed within the first 6 months postoperatively. Seventeen patients with bleeding symptoms were asked about their subjective assessment of improvement. Fifteen pa-tients reported significant improvement in symptoms and 1 patient reported only minimal improvement. Only 1 patient, who underwent TRFA and endometrial resection, did not report any improvement. No increase in symptoms was observed. Conclusions: Although TRFA is an approved method, it is not yet widely used worldwide. The combined procedure has been rarely used. The aim of our work is to show through our case series that transcervical radiofrequency abla-tion can be combined with surgical hysteroscopy for fibroid and/or endometrial resection without any additional risk

Transcervical radiofrequency ablation of focal adenomyosis: pilot results

AbstractObjective: Adenomyosis is a common gynecological disease, which occurs in women in reproductive age and is characterized by the presence of endometrial glands and stroma within the myometrium. Abnormal uterine bleeding, pelvic pain as well as infertility can be associated with adenomyosis. There are two main types of adenomyosis: diffuse and focal. Previously, adenomyosis was diagnosed only upon histopathological examination after hysterectomy and/or adenomyomectomy. However, the development of imagining techniques such as transvaginal ultrasound and magnetic resonance imaging enables the diagnosis of adenomyosis (diffuse and focal) without any surgical intervention. When medical therapy is contraindicated or ineffective, or if patients have a fertility desire, a surgical treatment may be necessary.Methods: In this study, a total of 13 patients with 16 areas of focal adenomyosis were treated. All patients provided their informed consent to undergo transcervical adenomyosis ablation treatment with the Sonata System, aware that the safety and effectiveness of transcervical radiofrequency (RF) ablation for the treatment of adenomyosis has not been established. Follow-up was performed six months after Sonata treatment.Results: The positive results relating to the improvement of symptoms and reduction of adenomyosis lesion size were observed in our study.Conclusion: Transcervical RF ablation with the Sonata System may be a promising therapeutic alternative method to conventional procedures such as hysterectomy for the treatment of focal adenomyosis, disease which has limited therapeutic approach, and may enable a minimally invasive, uterine preserving option