Presentation of an open entry technique for laparoscopy through a congenital defect in the umbilical fascia.

OBJECTIVE: We present and describe a modification of the Hasson open entry technique to gain access to the abdominal cavity for laparoscopy in which a congenital defect in the umbilical fascia is identified for entry into the peritoneum and insertion of the primary port. METHODS: A single centre, prospective, observational, pilot study has been conducted with no change in clinical practice. Data regarding the success of the technique, time to laparoscope insertion, complications and patient risk factors were collected and presented. RESULTS: The team enrolled 114 patients that had the St Helier technique attempted for entry in the abdominal cavity. Entry was achieved for all patients. The technique had 82.5 % success rate while this reduced to 65 % in patients with previous laparoscopies. The mean time to insertion of the laparoscope was 220 s, and there was no significant difference in success with variation in BMI. We recorded no minor or significant intra-operative complications. The superficial wound infection rate was 2.6 % with no other postoperative complications identified at 6-week follow-up. CONCLUSIONS: The presented technique is a safe and successful method of laparoscopic entry with a presumed shorter time until laparoscope insertion than other techniques used. The absence of complications could be attributed to the avoidance of sharp dissection of the umbilical fascia. The less invasive nature could reduce risks of hematoma, infection or hernia that are associated with the standard entry techniques used. Formal studies of long-term outcomes are required, as well as evaluating use in emergency and contaminated cases.

Global changes in maternity care provision during the COVID-19 pandemic: A systematic review and meta-analysis.

BACKGROUND: The COVID-19 pandemic has had a profound impact on healthcare systems globally, with a worrying increase in adverse maternal and foetal outcomes. We aimed to assess the changes in maternity healthcare provision and healthcare-seeking by pregnant women during the COVID-19 pandemic. METHODS: We performed a systematic review and meta-analysis of studies of the effects of the pandemic on provision of, access to and attendance at maternity services (CRD42020211753). We searched MEDLINE and Embase in accordance with PRISMA guidelines from January 1st, 2020 to April 17th 2021 for controlled observational studies and research letters reporting primary data comparing maternity healthcare-seeking and healthcare delivery during compared to before the COVID-19 pandemic. Case reports and series, systematic literature reviews, and pre-print studies were excluded. Meta-analysis was performed on comparable outcomes that were reported in two or more studies. Data were combined using random-effects meta-analysis, using risk ratios (RR) or incidence rate ratios (IRR) with 95% confidence intervals (CI). FINDINGS: Of 4743 citations identified, 56 were included in the systematic review, and 21 in the meta-analysis. We identified a significant decrease in the number of antenatal clinic visits (IRR 0614, 95% CI 0486-0776, P<00001, I2=54.6%) and unscheduled care visits (IRR 0741, 95% CI 0602-0911, P = 00046, I2=00%) per week, and an increase in virtual or remote antenatal care (IRR 4656 95% CI 7762-2794, P<00001, I2=90.6%) and hospitalisation of unscheduled attendees (RR 1214, 95% CI 1118-1319, P<00001, I2=00%). There was a decrease in the use of GA for category 1 Caesarean sections (CS) (RR 0529, 95% CI 0407-0690, P<00001, I2=00%). There was no significant change in intrapartum epidural use (P = 00896) or the use of GA for elective CS (P = 079). INTERPRETATION: Reduced maternity healthcare-seeking and healthcare provision during the COVID-19 pandemic has been global, and must be considered as potentially contributing to worsening of pregnancy outcomes observed during the pandemic.

Effects of the COVID-19 pandemic on maternal and perinatal outcomes: a systematic review and meta-analysis.

BACKGROUND: The COVID-19 pandemic has had a profound impact on health-care systems and potentially on pregnancy outcomes, but no systematic synthesis of evidence of this effect has been undertaken. We aimed to assess the collective evidence on the effects on maternal, fetal, and neonatal outcomes of the pandemic. METHODS: We did a systematic review and meta-analysis of studies on the effects of the pandemic on maternal, fetal, and neonatal outcomes. We searched MEDLINE and Embase in accordance with PRISMA guidelines, from Jan 1, 2020, to Jan 8, 2021, for case-control studies, cohort studies, and brief reports comparing maternal and perinatal mortality, maternal morbidity, pregnancy complications, and intrapartum and neonatal outcomes before and during the pandemic. We also planned to record any additional maternal and offspring outcomes identified. Studies of solely SARS-CoV-2-infected pregnant individuals, as well as case reports, studies without comparison groups, narrative or systematic literature reviews, preprints, and studies reporting on overlapping populations were excluded. Quantitative meta-analysis was done for an outcome when more than one study presented relevant data. Random-effects estimate of the pooled odds ratio (OR) of each outcome were generated with use of the Mantel-Haenszel method. This review was registered with PROSPERO (CRD42020211753). FINDINGS: The search identified 3592 citations, of which 40 studies were included. We identified significant increases in stillbirth (pooled OR 1·28 [95% CI 1·07-1·54]; I2=63%; 12 studies, 168 295 pregnancies during and 198 993 before the pandemic) and maternal death (1·37 [1·22-1·53; I2=0%, two studies [both from low-income and middle-income countries], 1 237 018 and 2 224 859 pregnancies) during versus before the pandemic. Preterm births before 37 weeks' gestation were not significantly changed overall (0·94 [0·87-1·02]; I2=75%; 15 studies, 170 640 and 656 423 pregnancies) but were decreased in high-income countries (0·91 [0·84-0·99]; I2=63%; 12 studies, 159 987 and 635 118 pregnancies), where spontaneous preterm birth was also decreased (0·81 [0·67-0·97]; two studies, 4204 and 6818 pregnancies). Mean Edinburgh Postnatal Depression Scale scores were higher, indicating poorer mental health, during versus before the pandemic (pooled mean difference 0·42 [95% CI 0·02-0·81; three studies, 2330 and 6517 pregnancies). Surgically managed ectopic pregnancies were increased during the pandemic (OR 5·81 [2·16-15·6]; I2=26%; three studies, 37 and 272 pregnancies). No overall significant effects were identified for other outcomes included in the quantitative analysis: maternal gestational diabetes; hypertensive disorders of pregnancy; preterm birth before 34 weeks', 32 weeks', or 28 weeks' gestation; iatrogenic preterm birth; labour induction; modes of delivery (spontaneous vaginal delivery, caesarean section, or instrumental delivery); post-partum haemorrhage; neonatal death; low birthweight (<2500 g); neonatal intensive care unit admission; or Apgar score less than 7 at 5 min. INTERPRETATION: Global maternal and fetal outcomes have worsened during the COVID-19 pandemic, with an increase in maternal deaths, stillbirth, ruptured ectopic pregnancies, and maternal depression. Some outcomes show considerable disparity between high-resource and low-resource settings. There is an urgent need to prioritise safe, accessible, and equitable maternity care within the strategic response to this pandemic and in future health crises. FUNDING: None.

GABI-balance--a non-interventional observational study on the effectiveness of tiagabine in add-on therapy in partial epilepsy.

BACKGROUND AND PURPOSE: Effectiveness of tiagabine (TGB) in open-label studies tends to be higher than in controlled, especially premarketing, studies. This article presents results of an open-label prospective study GABI-balance carried out in Poland and designed to evaluate effectiveness of TGB in add-on therapy of refractory partial and/or secondarily generalized epilepsy. MATERIAL AND METHODS: Data of 1979 patients (54%--M, 46%--F, mean age 39.2 years) with a mean history of 10.9 years of epilepsy were analyzed. Total initial number of epileptic seizures (n = 12,162) included simple partial seizures (n = 4702; 38.7%), complex partial seizures (n = 7083; 58.7%) and/or secondarily generalized partial seizures (n = 6408; 52.7%). The mean 4-week seizure rate per patient during the period preceding TGB therapy was 6.4. TGB was used over 16 weeks, starting from 5 mg/day with subsequent upwards titration. Results of the treatment were evaluated after 8 and 16 weeks. Assessments included reduction of mean monthly seizure rate, percentage of responders with seizure rate reduction of 50% or more, number of patients who completed the study, adverse effects, and Clinical Global Impression (CGI) scale. RESULTS: The mean initial seizure rate per patient (6.4) decreased to 3.3 after 8 weeks and to 1.8/month after 16 weeks. The mean initial dose of TGB--9.2 mg/day--was contemporarily increased to 23.4 and 29.9 mg/d, respectively. Percentage of responders with > or = 50% reduction of seizure rate reached 52% after 8 weeks and 77.2% after 16 weeks; 93.7% of patients were still observed after 16 weeks. Adverse effects, reported by 12.7% of patients after 8 weeks and 8.6% after 16 weeks, were mild or moderate. No serious adverse events were observed. The most frequent were somnolence/fatigue, headache/nausea, anxiety/mood disorders. According to treating physicians, add-on therapy with tiagabine in the GABI-balance study was highly effective in more than 80% of patients. CONCLUSIONS: Our results indicate that in everyday neurological outpatient practice, the add-on TGB therapy in patients with active partial and/or secondarily generalized epilepsy improved efficacy of the treatment with high safety maintained. Higher doses resulted in better effects of the therapy, and adverse effects were mild and less frequent with treatment duration.

Pattern of adverse events of antiepileptic drugs: results of the aESCAPE study in Poland.

INTRODUCTION: The Adverse Event Scale in Patients With Epilepsy (aESCAPE) European study (NCT00394927) explored and analyzed adverse events (AEs) and reasons for modifying treatment in patients treated with newer and older antiepileptic drugs (AEDs) used in monotherapy or polytherapy. The present analysis concerns the results of patients recruited in Poland. MATERIAL AND METHODS: Multicentre, international, observational, cross-sectional study investigating AEs in patients with epilepsy (aged ≥ 4 years), on stable AED treatment with one or two AED(s) for ≥ 3 months, using standardized questionnaires completed by a physician during a single study visit. RESULTS: Out of 309 patients, 24.6% were treated exclusively with newer AED(s) in monotherapy or in combination, while 75.4% were treated with older AED(s) or a combination of older and newer AED(s). 60.8% were on monotherapy, and 39.9% on polytherapy. In general, 73.8% of patients reported ≥ 1 AE(s). There were no significant differences in the frequency of reported AEs in compared groups. The most common were disturbances in cognitive function (40.5%), psychological problems (36.2%), and sedation (32.7%). Some AEs were found to be more specific for particular types and treatment regimens. Changes in treatment or dose during the study visit occurred in 22.3% of the patients, mainly due to lack of efficacy (10.7%), AEs (5.2%) or absence of seizures (4.5%). CONCLUSIONS: A detailed structured interview revealed high frequency of AEs in patients treated with AEDs. The main reasons for treatment modifications at the study visit were lack of efficacy, adverse events and absence of seizures.

The effect of epilepsy on emotional state in Hamilton and Beck questionnaire studies.

Patients with epilepsy present higher rate of psychological and psychiatric problems and emotional disturbances are estimated as the most frequent ones with prevalence of depression about tree times higher than it was observed in general population. In the presented study the occurrence of depressive symptoms was compared in a total of 60 adult patients with newly recognized and chronic epilepsy during remission of illness as well as pharmacoresistant. 21-items Hamilton Depressive Scale and Beck Depressive Inventory were applied once in each testified patient, consecutively by a physician or a patient himself during interictal period. Our study has found a higher level of depressive signs in newly diagnosed than in chronic patients during remission of illness but also in patients with an active process. The scoring rates both on HDRS and BDI were respectively characteristic of moderate or mild intensity of depressive disturbances. This comparison allows us to make a suggestion that diagnosis of epilepsy with its well-known stigmatization and limitations of different life activities may act as a stressing factor that enhances anxiety and depressive reactions in early phase of illness.

Effectiveness of adjunctive therapy with tiagabine in mentally disabled patients with epilepsy.

Previous reports justified positive impact of tiagabine, a new-generation antiepileptic drug on neuropsychological functioning as well as minimal risk of psychiatric exacerbations. In this prospective, open, observational, non-comparative, short-term--6 months' study we evaluated efficacy and tolerability of tiagabine as add-on in polytherapy in 30 young adults with both refractory epilepsy and mild or moderate mental retardation. About 40% of patients experienced improvement in seizure frequency of 50% or more and none complained of seizure deterioration. Overall seizure frequency fell down from a mean 9.9 at the baseline to 6.3 seizure days per month. The seizure rate was reduced from 14.9 to 9.2 per month after 24 weeks of add-on phase. Adjunctive tiagabine therapy appeared to be associated with reduction in overall seizure severity characteristics expressed as enhancement of mild seizures from 30 to 50% of patients and reduction in severe seizures from 30 to 16%. Responders reported an improvement in most health-related quality of life domains but mostly cognition, medication effects and social functioning. The majority (90%) of patients did not report additional adverse effects with tiagabine; the most common complains associated with central nervous system (vertigo, weakness, nervousness) were transient and did not cause discontinuation. Blood counts and liver functional tests did not show any clinically relevant changes. In this short-term observation tiagabine seemed to be a beneficial antiepileptic drug for mentally retarded patients with epilepsy as it decreased seizure frequency and severity, improved the patients' sense of the quality of life without enhancement of the risk of adverse effects in polytherapy.