Clinical Practice Research Research Articles

Safety assessment of the prophylactic use of silicone gel sheets (Lady Care®) for the prevention of hypertrophic scars following caesarean section

This study aimed to investigate the side effects of silicone gel sheet (Lady Care®) and evaluate its prophylactic efficacy in preventing abnormal scarring. Sixty women who underwent caesarean section were recruited from September 2016 to September 2017 in this prospective study. Lady Care® was applied from the 2nd to the 6th postoperative months. Side effects of Lady Care® were evaluated through medical examinations and questionnaires. A plastic surgeon diagnosed abnormal scarring. Pruritus was diagnosed in 25 (47.2%) patients; folliculitis, four (7.5%); dry skin, four (7.5%); contact dermatitis, three (5.7%); wound infection, two (3.8%); and epidermolysis, one (1.9%), albeit with mild severity. Following Lady Care® application, no abnormal scarring and mild hypertrophic scarring was observed in 32 (64.0%) and 18 (36.0%) patients respectively. Of seven patients with pre-existing hypertrophic scars, only two showed hypertrophic scarring after Lady Care® application. Our findings support the safety and prophylactic efficacy of Lady Care®. Impact Statement What is already known on this subject? The incidence of abnormal scarring, i.e. keloid or hypertrophic scar formation after caesarean section (CS) is reported to be ∼41%. Abnormal or excessive scar formation can lead to functional limitations, pruritus, pain and cosmetic issues. Studies have also shown a prophylactic effect of the application of silicone materials against the development of hypertrophic and keloid scars, though prohibitive cost and lack of adhesiveness of such gel sheets are known factors limiting their usage. What the results of this study add? The new silicone gel sheet ‘Lady Care®’ has strong adhesive properties and is consequently not easily peeled off. Furthermore, it is easy to use and economically efficient. What the implications are of these findings for clinical practice and/or further research? This is the first clinical trial on the application of Lady Care® silicone gel sheet for the prevention of CS scarring. Our findings support the safety and prophylactic efficacy of Lady Care®.

The prediction of surgical intervention in patients with tubo-ovarian abscess

The aim of this study was to compare the clinical characteristics of patients with tubo-ovarian abscess (TOA) who responded to medical treatment and those who underwent surgical intervention due to medical treatment failure. Electronic medical records were evaluated retrospectively to identify patients who were diagnosed with TOA. Demographic, clinical, and laboratory data including white blood cell (WBC) count, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were compared between the medical treatment group and the surgical intervention group. Patient age, TOA diameter, WBC count, CRP, and ESR were significantly different between the groups. On multiple regression analysis, significant correlations were identified between age (p = .001), ESR (p = .045), and failure of medical treatment. TOA diameter (p = .065) showed a borderline association with surgical intervention. The risk of needing surgical intervention in TOA patients can be predicted using ESR in addition to age and TOA size as risk factors. IMPACT STATEMENT What is already known on this subject? For patients diagnosed with a tubo-ovarian abscess (TOA), the size of TOA and the patient’s age are helpful for early identification of patients who are likely to need surgical treatment. Inflammatory markers such as C-reactive protein and white blood cell are also associated with the risk of surgical intervention. What do the results of this study add? Erythrocyte sedimentation rate (ESR) in addition to the size of TOA and the patient’s age is a useful marker in determining whether to undergo surgery in patients with TOA. What are the implications of these findings for clinical practice and/or further research? ESR combined with the patient’s age and the size of TOA is clinically useful in predicting the need for early surgical intervention in patients with TOA. Large prospective controlled studies are required to establish relationship between inflammatory markers and the risk of surgical intervention.

Abnormal glucose challenge test in absence of oral glucose tolerance test – are there consequences?

This is a retrospective analysis of mothers with abnormal 1-hour, 50-grams glucose challenge test (GCT) who did not take a 3-hour, 100-gram oral glucose tolerance test (OGTT). This study group of women was compared to three control groups, based on an OGTT diagnostic test- normal OGTT, single pathological value and gestational diabetes mellitus. Overall- 4,185 women were included and sub-divided accordingly into four groups: Group A-340 (8.12%)- no OGTT; Group B-2,585 (61.77%)- Norm OGTT (All values normal); Group C- 564 (13.48%)- SinOGTT (single pathological value) and Group D- 696 (16.63%)- Gestational Diabetes Mellitus (GDM, ≥ 2 pathological values). Groups A, C and D had higher rates of intrapartum Caesarean Delivery (10.29%, 11.52% and 10.19% vs. 8.43%, p < .0001). Group A had highest rates of neonatal adverse outcomes, as neonatal intensive care unit (NICU) admission (12.4% vs. 8.4%, 11.0% and 10.0%, p = .039), small for gestational age (SGA) neonates (7.0% vs. 5.3%, 3.7% and 6.0%, p = .0092) and neonatal hypoglycaemia (3.5% vs. 1.3%, 3.2% and 2.9%, p = .007). A multivariable regression revealed that having an abnormal GCT without an OGTT was an independent risk factor for neonatal intensive care unit admission, neonatal hypoglycaemia and intrapartum caesarean delivery. We concluded that women with pathological GCT who did not complete OGTT have higher rates of obstetric adverse outcomes. They should be closely monitored during delivery and should not be overlooked. IMPACT STATEMENT What is already known on this subject? Adverse outcomes of gestational diabetes mellitus are well established. But, the group of women who fail to complete a confirmatory OGTT following a pathological GCT is not well described. What the results of this study add? Our results point out that women who fail to complete an OGTT, suffer from higher rates of obstetric complications, presumably attributed to disrupted glucose values, but also to poor prenatal care. What the implications are of these findings for clinical practice and/or further research? These women should not be overlooked. They should be closely monitored during labour and delivery.

Comparison of two different starting doses of recombinant follicle stimulating hormone (rFSH) for intrauterine insemination (IUI) cycles in non-obese women with polycystic ovary syndrome (PCOS): a retrospective cohort study

We aimed to compare the efficacy of two different starting doses of recombinant follicle stimulating hormone (rFSH), 37.5 vs. 75 international units (IU) for intrauterine insemination (IUI) cycles in non-obese women with polycystic ovary syndrome (PCOS). A total of 109 women who underwent first rFSH stimulated IUI cycle were included in this retrospective cohort study. The primary outcome measure was the clinical pregnancy rate. No significant difference was found in terms of clinical pregnancy rate between the two groups (22% for the 37.5-IU group and 24% for the 75-IU group, respectively, p = .808). There was no significant difference in monofollicular development rate among the groups (p = .354). The total rFSH consumption was lower in the 37.5-IU group compared to the 75-IU group (p< .001). There was no statistically significant difference in pregnancy rates between the 37.5-IU and 75-IU groups in both normal weight (BMI: 19–24.9 kg/m2) and overweight (BMI: 25–29.9 kg/m2) women (p = .889 and .518, respectively). These results suggest that the starting doses of 37.5 and 75 IU of rFSH do not show significant difference in clinical pregnancy rates in non-obese PCOS women undergoing IUI cycles. Impact Statement What is already known on this subject? Low-dose gonadotropin treatment is advised for women with polycystic ovary syndrome (PCOS). However, there are few comparative data on the efficacy of different starting doses of recombinant follicle stimulating hormone (rFSH) for intrauterine insemination (IUI) cycles in PCOS women. What the results of this study add? There was no statistically significant difference in pregnancy rates of non-obese patients with PCOS having IUI whether rFSH was started at 37.5 or 75 international units (IU). What the implications are of these findings for clinical practice and/or further research? A starting dose of 37.5 IU of rFSH may be a reasonable approach for IUI cycles in non-obese PCOS women.

The correlation between endometrial thickness and the criteria for MTX treatment for ectopic pregnancy

Ectopic pregnancy (EP) occurs in approximately 2% of all pregnancies. A common method of treatment is methotrexate therapy, considered in haemodynamically stable patients. Endometrial thickness has been investigated as a tool for diagnosing EP. The objective of this study was to evaluate the association between endometrial thickness and the criteria for MTX treatment, in an attempt to facilitate outcome prediction. We retrospectively collected data from records of patients diagnosed with EP between 2012 and 2014 including information regarding the mode of treatment and outcome. The endometrial thickness was compared between cases that met the criteria for MTX treatment and those who did not. Of 267 cases of EP that were reviewed, 108 patients were treated with MTX. The MTX treatment success rate was 88%. Endometrial thickness was found to be significantly and inversely associated with criteria for MTX treatment. In conclusion, an association was found between the endometrial thickness and the criteria for selection of MTX treatment for EP. This may be a useful tool in treatment selection for EP. Impact Statement What is already known on this subject? Transvaginal sonography along with β-human chorionic gonadotrophin (β-hCG) monitoring is the standard for evaluation of suspected ectopic pregnancy (EP). The most specific sonographic finding for EP is the presence of a live extra uterine pregnancy. In research conducted with the purpose of finding intrauterine sonographic findings associated with EP, this condition has been shown to be correlated with a thinner endometrial lining, compared with that of an intrauterine pregnancy. What the results of this study add? The results of this study add information on the subject of methotrexate treatment success rates in correlation with the endometrial thickness. What the implications are of these findings for clinical practice and/or further research? The findings of this study contribute to the process of treatment selection for ectopic pregnancy by emphasising the association between a thick endometrium and the lower success rates of MTX treatment.

The traffic light pilot study: assessing the level of evidence for interventions in obstetrics and gynaecology

Evidence-based medicine tries to support clinicians through research, integrated with clinical skill and patient values. This pilot study aimed to assess appropriateness and level of evidence of current clinical practices, through evaluating availability and quality of guidelines. A prospective observational study in a large tertiary hospital network was performed, sampling diagnostic and therapeutic interventions in obstetrics and gynaecology. Interventions performed were justified against knowledge in the published literature, and guideline recommended practice. We collected 58 patient observations, 40(69%) in obstetrics, 18(31%) in gynaecology. There were local guidelines relevant in 52%, national in 22%, and international guidelines in 12%. In 50 interventions with available guidelines, 54% provided strong and clear recommendations for practice, and were supported by research-based knowledge. Similarly, 66% of encounters were thought to be in concordance with research-based knowledge. There was good concordance between interventions and guideline recommendations. However, half of guidelines reviewed had limited or no knowledge to justify their recommendations. IMPACT STATEMENT What is already known on this subject? Evidence based medicine should aim to improve patient outcomes. However, available trials assessing effectiveness of established practices suggest that they convey little to no benefit to patients. There remains a paucity of evidence for established practices in obstetrics and gynaecology What do the results of this study add? This pilot study assesses the usefulness of interventions in obstetrics and gynaecology and confirms the feasibility of collecting and coding our interventions and clinical practices with a traffic light system. What are the implications of these findings for clinical practice and/or further research? These findings demonstrate the feasibility of our traffic lights grading system within obstetrics and gynaecology. It demonstrates this method is useful to assess what knowledge base is guiding clinical practice, how well practice concords with guidelines and literature, as well as the presence and significance of any gaps in knowledge. These early findings will be used in an expanded study and have implications on the way healthcare effectiveness is evaluated, as well as reducing healthcare expenditure in obstetrics and gynaecology.

Indirect acute effects of the COVID-19 pandemic on physical and mental health in the UK: a population-based study

SummaryBackgroundThere are concerns that the response to the COVID-19 pandemic in the UK might have worsened physical and mental health, and reduced use of health services. However, the scale of the problem is unquantified, impeding development of effective mitigations. We aimed to ascertain what has happened to general practice contacts for acute physical and mental health outcomes during the pandemic.MethodsUsing de-identified electronic health records from the Clinical Research Practice Datalink (CPRD) Aurum (covering 13% of the UK population), between 2017 and 2020, we calculated weekly primary care contacts for selected acute physical and mental health conditions: anxiety, depression, self-harm (fatal and non-fatal), severe mental illness, eating disorder, obsessive-compulsive disorder, acute alcohol-related events, asthma exacerbation, chronic obstructive pulmonary disease exacerbation, acute cardiovascular events (cerebrovascular accident, heart failure, myocardial infarction, transient ischaemic attacks, unstable angina, and venous thromboembolism), and diabetic emergency. Primary care contacts included remote and face-to-face consultations, diagnoses from hospital discharge letters, and secondary care referrals, and conditions were identified through primary care records for diagnoses, symptoms, and prescribing. Our overall study population included individuals aged 11 years or older who had at least 1 year of registration with practices contributing to CPRD Aurum in the specified period, but denominator populations varied depending on the condition being analysed. We used an interrupted time-series analysis to formally quantify changes in conditions after the introduction of population-wide restrictions (defined as March 29, 2020) compared with the period before their introduction (defined as Jan 1, 2017 to March 7, 2020), with data excluded for an adjustment-to-restrictions period (March 8–28).FindingsThe overall population included 9 863 903 individuals on Jan 1, 2017, and increased to 10 226 939 by Jan 1, 2020. Primary care contacts for almost all conditions dropped considerably after the introduction of population-wide restrictions. The largest reductions were observed for contacts for diabetic emergencies (odds ratio 0·35 [95% CI 0·25–0·50]), depression (0·53 [0·52–0·53]), and self-harm (0·56 [0·54–0·58]). In the interrupted time-series analysis, with the exception of acute alcohol-related events (0·98 [0·89–1·10]), there was evidence of a reduction in contacts for all conditions (anxiety 0·67 [0·66–0·67], eating disorders 0·62 [0·59–0·66], obsessive-compulsive disorder [0·69 [0·64–0·74]], self-harm 0·56 [0·54–0·58], severe mental illness 0·80 [0·78–0·83], stroke 0·59 [0·56–0·62], transient ischaemic attack 0·63 [0·58–0·67], heart failure 0·62 [0·60–0·64], myocardial infarction 0·72 [0·68–0·77], unstable angina 0·72 [0·60–0·87], venous thromboembolism 0·94 [0·90–0·99], and asthma exacerbation 0·88 [0·86–0·90]). By July, 2020, except for unstable angina and acute alcohol-related events, contacts for all conditions had not recovered to pre-lockdown levels.InterpretationThere were substantial reductions in primary care contacts for acute physical and mental conditions following the introduction of restrictions, with limited recovery by July, 2020. Further research is needed to ascertain whether these reductions reflect changes in disease frequency or missed opportunities for care. Maintaining health-care access should be a key priority in future public health planning, including further restrictions. The conditions we studied are sufficiently severe that any unmet need will have substantial ramifications for the people with the conditions as well as health-care provision.FundingWellcome Trust Senior Fellowship, Health Data Research UK.

Evidence-based interventional radiology: past, present and future

Evidence-based interventional radiology is the result of the evolution and integration of evidence-based medicine and interventional radiology. It adopts the concepts and methods of evidence-based medicine to guide the best clinical practice in interventional radiology. We aim to systematically elaborate on the status quo of Clinical Research, Systematic Review/Meta-Analysis and Clinical Practice Guidelines in interventional radiology, analyze the existing problems, and put forward thoughts and suggestions on promoting the development of evidence-based interventional radiology in the future.

Chronic Primary Pain of the Spine: an Integrative Perspective Part 2

The purpose of this review is to provide a follow-up discussion to a companion article reviewing current models of low back and neck pain, focused on chronic and disabling primary pain of the spine. While the preceding article addresses risk factors, etiology, pathophysiology, and differential diagnosis of low back and neck pain, this article discusses the best available research regarding current management strategies for chronic primary pain of the spine and expands upon ways to improve these strategies. A review of the English medical literature was performed using search terms “chronic primary pain,” “low back pain,” OR “neck pain” AND “management,” “treatment,” “prevention,” or “biopsychosocial.” Additional searches were made using Google Scholar and PubMed search engines through April 18, 2020. The authors reviewed and identified 136 relevant articles to be used in this discussion. While certain elements of societal and legislative infrastructure hinder optimized implementation of evidence-based care, clinical research and updated practice guidelines advocate for the safe and cost-effective nonpharmacological interventions typically offered by chiropractors, physical therapies, and other manual therapists as first-line care. The authors expand upon these therapies individually to determine their relevance and contextual purpose. A framework for an integrative perspective, adopting concepts from biopsychosocial and behavioral models, is called to action to provide an improved understanding of the nature of chronic primary pain and to aid in patient-centered clinical decision-making.

Screening for PIK3CA mutations among Saudi women with ovarian cancer

The study aimed to screen for PIK3CA gene mutations among Saudi women with Ovarian Cancer. The study included 298 Saudi women with epithelial ovarian cancers (EOC). DNA sequence analysis was employed to screen for the mutations. DNA sequence analysis of a coding region of exon 9 and 20 of PIK3CA gene revealed mutations in 37/298 (12.4%) EOC patients. About 21/37(56.8%) somatic mutations were identified in exons 9, and 16/37(43.2%) in exon 20. All analysed mutations were missense mutations, the frequencies of which varied from 2.7% to 43.2%. PIK3CA mutation was found to be significantly associated with age (p = .023), grade (p = .001) and histological types (p = .032). Only 6.6% of serous carcinomas and 3.8% of endometrioid had PIK3CA mutation. The Mutated PIK3CA gene was significantly involved in the pathogenesis of EOC among Saudi women. PIK3CA gene mutation and overexpression represent important clinical implications for diagnosis, and prognosis, which can be utilised for better EOC management. Impact statement What is already known on this subject? The detailed molecular and genetic phenomenon underlying the progression of these tumours is still unclear. Recently, the pathogenesis of ovarian cancer has been attributed to mutations of PIK3CA. What do the results of this study add? Mutation in the PIK3CA gene leads to altered PI3K/AKT signalling pathways responsible for the progression of the epithelial ovarian cancer. What are the implications of these findings for clinical practice and/or further research? The Mutated PIK3CA gene was significantly involved in the pathogenesis of EOC among Saudi women. PIK3CA gene mutation and overexpression represent important clinical implications for diagnosis, and prognosis, which can be utilised for better EOC management.

Sleep quality and obstructive sleep apnoea and triple screen test results in pregnancy

In this study, we aimed to examine the relationship between sleep quality, sleep apnoea and triple screen test results. This was an observational descriptive research study. The STOP questionnaire and the STOP-BANG questionnaire were performed to assess obstructive sleep apnoea risk and Pittsburgh Sleep Quality Index was used to evaluate sleep quality. The average Pittsburgh Sleep Quality Index score of the participants was 5.92 ± 3.26. According to the STOP test, 11.40% (87) of the pregnant women had a high risk of OSAS, and, according to the STOP-BANG test, 32 participants were under high risk of OSAS. An increased risk was detected in 1.30% of the participants in terms of Trisomy18 and in 1.60% in terms of neural tube defects. A direct and significant relationship was detected between Trisomy 21 risk and STOP-BANG score. This is the first study to show this relationship. Sufficient evidence needs to be collected on this issue. Testing in earlier weeks of pregnancy and in the conception period may allow more meaningful assessment of the relationship of OSAS with chromosomal abnormalities. IMPACT STATEMENT What is already known on this subject? There is a link between OSAS and epigenetic changes. Components of the triple screen test, levels of serum total β-hCG and unconjugated oestriol are increased in OSAS. What do the results of this study add? An increase in Trisomy 21 risk is correlated with increased OSAS risk. Alpha Fetoprotein levels were higher in the low OSAS risk group. What are the implications of these findings for clinical practice and/or further research? This is the first study to show this relationship. Sufficient evidence needs to be collected on this issue. Treatment of OSAS may be necessary during pregnancy.

Analysis of the prevalence of human papillomavirus and abnormal anal cytology in women at risk

Our aim was to analyze the association between anal human papillomavirus (HPV) infection and abnormal anal cytology in women with high-grade cervical intraepithelial neoplasia (CIN 2+). We also analysed what other risk factors might be significant. We carried out a prevalence study from April 2015 to March 2017 at La Paz University Hospital. Genotyping of HPV, anal cytology and high-resolution anoscopy were performed. Of 171 patients recruited, 53 cases (31%) were diagnosed as histological CIN 2+: there were no statistically significant differences in the prevalence of anal HPV (OR = 0.8), nor the prevalence of abnormal anal cytology (OR = 2.15, 95% CI 0.8–5.7) compared to women with CIN 1 or no cervical dysplasia. Immunosuppression (OR = 2.51, 95% CI 1–6.3, p < .05), cervical HPV (OR = 3.9, 95% CI 1.9–8.0, p < .01) and being older than 40 years old (p < .05) were also associated with anomalous anal results. Impact Statement What is already known on this subject? Anal HR-HPV and abnormal anal cytology may precede anal intraepithelial neoplasia (AIN): a premalignant lesion that may progress to anal cancer. It is known that there are four populations which present a higher risk of developing anal cancer compared to the general population: human immunodeficiency virus (HIV)-positive patients, other immunocompromised populations, men who have sex with men and women with a history of disease secondary to HPV infection. What do the results of this study add? This study allowed us to compare the prevalence of anal HPV and abnormal anal cytology in women with CIN 2+: it analysed whether these women already presented alterations in anal tests at the moment of the diagnosis of the preneoplastic cervical lesion. It also provides information for the management of the populations at a higher risk of developing anal cancer; specifically, the group of women with a prior history of HPV-associated anogenital disease. What are the implications of these findings for clinical practice and/or further research? Our findings improve the existing evidence on anal HPV infection and anal cytology on the least studied population at risk. Data could be useful for further research in order to clarify the role of anal screening in this population and standardise the clinical practice.

A study of the association between angiotensinogen (AGT) gene polymorphism (M235T) and preeclampsia in Thai pregnant women

AGT M235T gene polymorphism may cause increased blood pressure in preeclampsia in pregnancy; however, the evidence remains controversial. This study investigated the association between AGT M235T and preeclampsia in Thai pregnant women. A case-control study was conducted to compare the distributions of AGT M235T genotypes and alleles between 142 normotensive pregnancies as controls and 61 preeclampsia pregnancies as cases in a tertiary-care university hospital in Chiang Mai, Thailand. The results show that the distribution of AGT M235T genotypes (MM, MT and TT) of both groups were not significantly different (preeclampsia: 0.0, 16.4, 83.6%; control: 2.1, 22.5, 75.4%, respectively; p = .30). Additionally, there was no statistical difference in the distribution of AGT M235T alleles (M and T alleles) (preeclampsia: 8.2 and 91.8% versus control: 13.4 and 86.6%, respectively; p = .14). In this study, the distributions of AGT M235T were not different in both groups. Therefore, AGT M235T polymorphism may not play a significant role in preeclampsia pathophysiology in Thai population. Impact statement What is already known on this subject? Preeclampsia is one of the major complications during pregnancy; it significantly affects maternal and perinatal morbidity and mortality. Effort has been made to find markers and predictors that are associated with the pathophysiology of preeclampsia. AGT M235T gene polymorphism may cause increased blood pressure in preeclampsia pregnancy; however, evidences are still controversial. What do the results of this study add? We conducted a case-control study to compare the distributions of AGT M235T genotypes and alleles between 142 normotensive pregnancies as controls and 61 preeclampsia pregnancies as cases. The results show that preeclamptic women are more likely to deliver at an earlier gestational age and have a smaller baby in comparison with the normotensive group. In addition, women with preeclampsia had a higher chance of having an operative delivery and caesarean section. However, the distribution of AGT M235T polymorphism of preeclampsia women and the control group were not significantly different. What are the implications of these findings for clinical practice and/or further research? AGT M235T polymorphism may not play a significant role in preeclampsia pathophysiology in Thai population.

The BD Odon Device™: an update of its current state

The BD Odon Device™ was designed as an alternative to conventional methods for assisting vaginal delivery, especially in low-resource settings. This a systematic review of published data concerning the BD Odon Device™ until March 2020 listed in Pubmed, Google Scholar, SCOPUS and Web of Science. Five studies testing the device were found, three in models and two in women with uncomplicated deliveries. According to their results, the device seems easy to use, safe, effective and requires simple and fast training, so it may become a good alternative to vacuum extractor or forceps, especially in places where there is less specialised staff, low-resources settings. The study protocol of the first study in complicated second stages has already been published. There is still few information about the BD Odon Device™ in scientific literature, however more research concerning the device is expected to take place in a near future. Impact Statement What is already known on this subject? The Odon DeviceTM is a device under development that aims to be a useful tool to assist vaginal deliveries. What do the results of this study add? This is a review of the current state of the development of the Odon DeviceTM. Further tests in humans are planned in the future in order to evaluate its safety and efficacy. What are the implications of these findings for clinical practice and/or further research? The Odon DeviceTM may be a promising tool to assist vaginal deliveries, especially in low-resource countries and countries with high rates of C-section during second stage of labour, but further research is needed to evaluate its safety and efficacy.

The incidence of unexpected gynaecological malignancies in hysterectomies carried out for benign indications

The aim of the present study was to determine the incidence of unexpected gynaecological malignancies in patients undergoing hysterectomy for benign indications and to evaluate their clinical characteristics. Data from 6448 cases who had undergone hysterectomy for benign indications between the dates of 01.01.2008–01.01.2018 were recorded retrospectively from the database of the institution. The mean age of the cases with malignancy was 59.2 ± 9.66 (45–80) and 76,31% were (29/38) postmenopausal. The mean gravidity was 3.94 ± 1.73 and parity was 3.31 ± 1.45. Their mean BMI was 29.6 ± 4.26 kg/m2 (22.4–41.9 kg/m2 range). These patients were followed for a mean duration of 60.68 ± 37.66 months and during this period death associated with malignancy occurred in 4/38 (%10.52) cases, all of whom had leiomyosarcoma. The benign indications of procedure were as follows: myoma uteri (2675, 41.48%), abnormal uterine bleeding (1508, 23.38%), uterine prolapsus (793, 12.29%), ovarian cyst (619, 9.59%), endometriosis (303, 4.69%), endometrial polyp (264, 4.09%), pelvic pain (238, 3.69%) and other benign causes (48, 0.74%). Unexpected gynaecological malignancy was found in 20 cases (0.31%) with endometrial cancer, in eight cases (0.12%) with uterine sarcoma, in seven cases (0.10%) with ovarian cancer, in one case (0.01%) with tubal cancer and in two (0.03%) with cervical cancer. Gynaecological malignancy was found in 38 of 6648 cases who underwent hysterectomy for benign indications, yielding an incidence rate of 0.58%. IMPACT STATEMENT What is already known on this subject? Hysterectomy is the most common gynaecological surgery in the world and although most are performed for benign indications, unexpected gynaecological malignancy is possible in the final pathology results. Although there are available publications investigating unexpected gynaecological malignancy incidences after hysterectomies for benign reasons, the incidence is still not clear. We aimed to contribute to the existing literature with this study, which includes a large number of cases. What do the results of this study add? Our study adds new findings to the body of the knowledge on the incidence of unexpected gynaecological malignancies in hysterectomies for benign indications. Gynaecological malignancy was found in 38 of 6648 cases who underwent hysterectomy for benign indications, yielding an incidence rate of 0.58%. What are the implications of these findings for clinical practice and/or further research? There is an unexpected possibility of gynaecological malignancy even in cases where it is expected to be benign with current diagnostic methods. In cases that are expected to be benign, detailed preoperative evaluation should be performed in all patients to prevent unexpected gynaecological malignancies. More sensitive screening methods should be developed especially in the preoperative differential diagnosis of leiomyoma and leiomyosarcoma.

5,926 hysterectomies: complications described by Clavien–Dindo classification

Hysterectomy is the most common major gynaecological surgery. Due to its high volume, the analysis of its results is relevant. The objective of this study was to describe intraoperative complications and reoperations, for both benign and malignant causes, using the Clavien–Dindo classification (approved by local ethics committee, number 100220). Between 2000 and 2019, 5926 elective hysterectomies were performed, of which 90.2% were for benign aetiology and 9.8% for malignant causes. The abdominal route was 52.7%, vaginal 40.1% and laparoscopic 7.2%. Intraoperative complications and reoperations (grade III Clavien–Dindo) were 4% and 2.1%, respectively. Oncological surgery had significantly more intraoperative complications (10% vs. 3.4%) and reoperations (3.6% vs. 1.9%) than benign procedures. Noteworthy, intraoperative complications required a new operation in only 3.4% for malignant and 2.8% for benign surgery. Our data showed the relevance of detecting and rectifying intraoperative complications during surgery, which consequently leads to a lower reoperation rate, minimising postoperative morbidity and mortality for patients. Impact Statement What is already known on this subject ? The surgical complications of hysterectomy, both intraoperative and postoperative, are extensively described. However, this information is not well systematised, in which elective and emergency surgery are mixed. In addition to the above, there are few documents comparing the results of hysterectomies due to benign versus malignant causes. What the results of this study add? Using the Clavien–Dindo classification, this study adds an organised description of intraoperative complications and reoperations of hysterectomy in the context of elective surgery. In addition, it provides information on the comparison between surgery for benign versus malignant causes, as well as information on intraoperative complications requiring a new operation. What the implications are of these findings for clinical practice and/or further research? These findings provide clear and orderly data about the risks of elective hysterectomy and showed the relevance of detecting and rectifying intraoperative complications during the procedure. This is useful for specialists to preoperatively identify the risks for each hysterectomy group and provide their patients with more detailed information during informed consent.

Vulvovaginal atrophy of menopause and its impact on sexual function in an Italian clinical cohort of post-menopausal women

The aim of current study was to estimate the impact of vulvovaginal atrophy (VVA) on sexual function in a clinical population of Italian postmenopausal women. Women aged 45–75 years with at least one VVA symptom completed three questionnaires: Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI) and Female Sexual Distress Scale revised (FSDS-R). A gynaecological examination was performed for VVA confirmation. Among the 1,066 evaluable patients, VVA was confirmed in around 90% of the sample. Sexual function impairment was significantly higher in patients with confirmed VVA as observed by significant differences in the sexual function component of the DIVA questionnaire (p = .014), the FSDS-R (p < .0005), and the FSFI (p < .0005), as well as for all the FSFI subdomains: desire (p < .0005), arousal (p < .0005), lubrication (p < .0005), orgasm (p < .0005), satisfaction (p < .0005) and pain (p < .0005). Significant impairment of sexual function was demonstrated in Italian postmenopausal women who were clinically confirmed with signs of VVA through gynaecological examination. IMPACT STATEMENT What is already known on this subject: At least half of postmenopausal women report VVA associated symptoms with significant impact on sexual function and ultimately on sexual activity. What the results of this study add: As compared with patients without confirmed VVA, the negative impact on sexual function was significantly higher in patients with confirmed VVA. This difference was observed for the sexual function component (DIVA-C) of the DIVA questionnaire, for the overall FSDS-R result, and for the overall FSFI score, as well as for all the FSFI subdomains (desire, arousal, lubrication, orgasm, satisfaction and pain). What the implications are of these findings for clinical practice and/or further research: An impairment of sexual function is significantly associated with VVA diagnosis in Italian post-menopausal women, especially when diagnosis was objectively confirmed by clinical signs of VVA visible in the gynaecological examination. In addition, this study demonstrates that inquiring about VVA using a structured questionnaire may increase the diagnosis of VVA related changes in sexual function.

The effect of corrective and therapeutic exercises on bleeding volume and severe menstrual pain in non-athletic women

The aim of this study was to determine the relationship between lumbar lordosis and severe menstrual pain and bleeding for the improvement of the health status in women. This was a quasi-experimental study where the effects of a training program, (based on correctional and therapeutic exercises, on primary dysmenorrhoea and menstrual bleeding in women with hyper-lordosis) was determined. The severity of menstrual pain was evaluated by use of a questionnaire. There was a significant incidence of neurological pain, which was not reduced in the control group (who had no exercise). There was a significant relationship between the severity of menstrual pain and hyper-lordosis. In the intervention group, there was a significant decrease in the severity of menstrual pain following 12 weeks of exercise. Hyper-lordosis can be improved by performing corrective exercises and strengthening the abdominal muscles. Impact statement What is already known on this subject? Exercise is positively associated with changes in the menstrual cycle and has beneficial effects on menstruation. What do the results of this study add? This research determines the relationship between lumbar lordosis and severe menstrual pain and the association of severe menstrual bleeding, in order to take effective corrective actions to improve women’s health. What are the implications of these findings for clinical practice and/or further research? Hyper-lordosis can be improved by corrective exercises and strengthening of the abdominal muscles.

Assessment of cervical volume and spectral Doppler parameters in tumour dominant vessel of patients with locally advanced squamous cell cervical carcinoma

We evaluated cervical volume and spectral Doppler parameters: peak systolic velocity (PSV), resistance index (RI) and pulsatility index (PI) in the tumour dominant vessel of 50 patients with cervical squamous cell carcinoma (SCC) staged IIB and IIIB and their changes during treatment. The patients underwent transvaginal Doppler ultrasonography prior to treatment, after external beam radiation therapy (EBRT) and 6 weeks after brachytherapy. Radiotherapy decreased cervical volume and PSV values of the tumour dominant vessel. The PSV values before EBRT in G1 + G2 tumours were higher than in G3 tumours. No correlations between cervical volume, PSV, RI and PI values with disease-free survival (DFS) and overall survival (OS) were found. We concluded, that sonographic assessment of changes in cervical volume of patients with locally advanced cervical SCC during treatment did not allow to predict treatment results. Spectral Doppler parameters PSV, RI and PI of tumour dominant vessel did not predict prognosis for these patients. Impact Statement What is already known on this subject? Transvaginal Doppler sonography is considered as a useful diagnostic method in patients with cervical carcinoma. However, despite numerous studies, the value of spectral Doppler parameters in tumour dominant vessel and cervical volume of patients with locally advanced cervical SCC is still not well defined. What the results of this study add? In our prospective study, we found that sonographic assessment of changes in cervical volume of patients with locally advanced cervical SCC during treatment did not allow to predict treatment results and spectral Doppler parameters of tumour dominant vessel did not predict prognosis for these patients. What the implications are of these findings for clinical practice and/or further research? Our study underlines the limited value of spectral Doppler technique in patients with cervical carcinoma. Further research should be focussed on identifying and validating novel prognostic and predictive factors.

Echogenic particles in the amniotic fluid of term low-risk pregnant women: does it have a clinical significance?

In this study, we aimed to analyse the clinical features of the third-trimester pregnant women, with echogenic amniotic fluid and to compare their obstetric and neonatal outcomes with pregnant women with normal amniotic fluid echogenicity. This case-control study was conducted in a tertiary antenatal care centre. A total of 560 term (37–42 weeks of gestation) singleton women; 280 with echogenic particles in amniotic fluid and 280 with clear amniotic fluid, who delivered within 24 h after the ultrasound scan were evaluated. The women in the two groups were similar in terms of age, parity, body mass index, foetal birth weight, and gestational age. More patients in the particulate amnion group had lower Apgar scores (<7) in 1st and 5th minutes than controls (p = .006, p = .031 respectively) however the rate of admission to neonatal intensive care was similar. Vernix stained amniotic fluid was more common in the study group (48.8%, p = .031), the rate of meconium-stained amniotic fluid was similar in the study and control groups (9.6–9.2%, p = .881). The primary caesarean section rate was higher in women with particulate amnion (18.4%, p = .037). Echogenic particles in the amniotic fluid in the third trimester could not be attributed to meconium, however, higher rates of primary caesarean section may require further attention. IMPACT STATEMENT What is already known on this subject? Previous studies showed that high-density intra-amniotic particles were possibly related to vernix caseosa, intra-amniotic bleeding, and meconium. The number of study groups in these studies was also limited. What do the results of this study add? Additional to other previous studies, we found an increased rate of intra-amniotic echogenic particles in male foetuses. What are the implications of these findings for clinical practice and/or further research? The presence of echogenic particles on ultrasound was not related to increased risk for the presence of meconium. Significantly more neonates born to mothers with intra-amniotic echogenic particles tended to have lower Apgar scores (<7), however, this significant difference did not affect the need for NICU admission. The presence of echogenic particles in the amniotic fluid of the third-trimester pregnant women could not be attributed to meconium and adverse perinatal outcomes, however, the higher rates of primary caesarean section may require further attention.