LAparoscopic Versus Abdominal hysterectomy (LAVA): protocol of a randomised controlled trial.

INTRODUCTION: There is uncertainty about the advantages and disadvantages of laparoscopic hysterectomy compared with abdominal hysterectomy, particularly the relative rate of complications of the two procedures. While uptake of laparoscopic hysterectomy has been slow, the situation is changing with greater familiarity, better training, better equipment and increased proficiency in the technique. Thus, a large, robust, multicentre randomised controlled trial (RCT) is needed to compare contemporary laparoscopic hysterectomy with abdominal hysterectomy to determine the safest and most cost-effective technique. METHODS AND ANALYSIS: A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial with integrated health economic evaluation and an internal pilot with an embedded qualitative process evaluation. A within trial-based economic evaluation will explore the cost-effectiveness of laparoscopic hysterectomy compared with open abdominal hysterectomy. We will aim to recruit 3250 women requiring a hysterectomy for a benign gynaecological condition and who were suitable for either laparoscopic or open techniques. The primary outcome is major complications up to six completed weeks postsurgery and the key secondary outcome is time from surgery to resumption of usual activities using the personalised Patient-Reported Outcomes Measurement Information System Physical Function questionnaire. The principal outcome for the economic evaluation is to be cost per QALY at 12 months' postsurgery. A secondary analysis is to be undertaken to generate costs per major surgical complication avoided and costs per return to normal activities. ETHICS AND DISSEMINATION: The study was approved by the West Midlands-Edgbaston Research Ethics Committee, 18 February 2021 (Ethics ref: 21/WM/0019). REC approval for the protocol version 2.0 dated 2 February 2021 was issued on 18 February 2021.We will present the findings in national and international conferences. We will also aim to publish the findings in high impact peer-reviewed journals. We will disseminate the completed paper to the Department of Health, the Scientific Advisory Committees of the RCOG, the Royal College of Nurses (RCN) and the BSGE. TRIAL REGISTRATION NUMBER: ISRCTN14566195.

Laparoscopic removal of Essure device techniques, perioperative findings and evaluation of patient's satisfaction: A case series.

OBJECTIVE: To evaluate perioperative outcomes and symptom resolution in women undergoing Essure removal. METHODS: Single centre cohort study at a large University Teaching Hospital in the UK. Symptoms and Quality of life (QoL) were assessed using a standardised questionnaire administered at 6-months and up to 10-years following removal of Essure® devices. RESULTS: 61 women underwent surgical removal of Essure® devices representing 61/1087 (5.6%) of all women undergoing this hysteroscopic form of sterilization. Patients who had Essure® removal were more likely to have a previous caesarean section [38% vs 18%; OR 0.4, 95% CI 0.2-0.6; P <0.001]. The main indication for removal was pelvic pain (49/61, 80%). Removal was achieved by laparoscopic bilateral salpingectomy/cornuectomy (44/61,71%) or hysterectomy (17/61, 28%). At surgery, perforated device was seen in 4/61 (7%) cases. 26/61 (43%) of patients had concomitant pelvic pathology; 12/26 (46%) had fibrous adhesions, 8/26 (31%) endometriosis, 4/26 (15%) adenomyosis, and 2/26 (8%) had endometriosis and adenomyosis. 10 patients underwent further procedure following removal for ongoing symptoms. 55/61 women (90%) responded to the post removal symptom questionnaire. Most respondents to the quality of life survey 42/55 (76%) reported total or some improvement. 42/53 (79%) had total or some improvement in pelvic pain, 9/13 (69%) in mental health and 10/12 (83%) in bleeding. CONCLUSION: Surgical removal of Essure® devices appears to improve symptoms thought to be attributable to the presence of these uterine implants in most women. However, patients should be counselled that one in five women may experience persistent or even worsening symptoms.

Severe pre-eclampsia complicated by acute fatty liver disease of pregnancy, HELLP syndrome and acute kidney injury following SARS-CoV-2 infection.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has presented many diagnostic challenges and uncertainties. Little is known about common pathologies complicating pregnancy and how their behaviour is modified by the presence of SARS-CoV-2. Pregnancy itself can alter the body's response to viral infection, which can cause more severe symptoms. We report the first case of a patient affected with sudden-onset severe pre-eclampsia complicated by acute fatty liver disease of pregnancy, HELLP (haemolysis, elevated liver enzymes and low platelet) syndrome and acute kidney injury following SARS-CoV-2 infection. Although an initial diagnostic dilemma, a multidisciplinary team approach was required to ensure a favourable outcome for both the mother and the baby. Our case report highlights the need for health professionals caring for pregnant women to be aware of the complex interplay between SARS-CoV-2 infection and hypertensive disorders of pregnancy.

Maternal COVID-19 infection, clinical characteristics, pregnancy, and neonatal outcome: A prospective cohort study.

OBJECTIVE: To study the effect of COVID-19 on pregnancy and neonatal outcomes. STUDY DESIGN: Prospective cohort study in a large tertiary maternity unit within a university hospital with an average annual birth of over 10,000 births. We prospectively collected and analysed data for a cohort of 23 pregnant patients including singleton and multiple pregnancies tested positive for COVID-19 between February 2020 and April 2020 inclusive to assess the effect of COVID-19 on pregnancy, and neonatal outcomes. RESULTS: Twenty-three pregnant patients tested positive for COVID-19, delivering 20 babies including a set of twins, with four ongoing pregnancies at the time of manuscript submission. 16/23 (70 %) whom tested positive were patients from Asian (Indian sub-continent) background. The severity of the symptoms ranged from mild in 13/23 (65.2 %) of the patients, moderate in 2/23 (8.7 %), and severe in 8/23 (34.8 %). Four out of total 23 COVID-19 pregnant patients (17.4 %) developed severe adult respiratory distress syndrome complications requiring ICU support, one of whom led to maternal death 1/23 (4.3 %). 11/23 (48 %) of the patients had pre-existing co-morbidities, with morbid obesity 5/23 (21.7 %) and diabetes 4/23 (17.4 %) being the more commonly represented. Of the 23 pregnant patients 19 were in their third trimester of pregnancy and delivered; 7/19 (36.8 %) had preterm birth, 3/19 (15.8 %) developed adult respiratory distress syndrome before delivery, and 2/19 (10.5 %) had pre-eclampsia. 16/19 (84 %) of patients delivered by C-section. Out of the 20 new-borns, 18 were singletons with a set of twin. CONCLUSION: COVID-19 is associated with high prevalence of preterm birth, preeclampsia, and caesarean section compared to non-COVID pregnancies. COVID-19 infection was not found in the newborns and none developed severe neonatal complications.

The feasibility, safety, and effectiveness of hysteroscopic sterilization compared with laparoscopic sterilization.

BACKGROUND: In contrast to conventional laparoscopic sterilization, newer hysteroscopic approaches avoid the need for hospital admission, general anesthesia, and prolonged recovery. However, there are concerns that the feasibility, safety, and efficacy of hysteroscopic sterilization may be lower than established laparoscopic sterilization. OBJECTIVE: We sought to evaluate the outcomes of hysteroscopic sterilization compared with laparoscopic sterilization in routine clinical practice in a comparative observational cohort study. STUDY DESIGN: This study was carried out at University of Birmingham, United Kingdom, National Health Service teaching hospital, office hysteroscopy clinics, and day-case hospital unit. In all, 1085 women underwent hysteroscopic sterilization and 2412 had laparoscopic sterilization. Hysteroscopic sterilization was carried out using the tubal implant permanent birth control system in the office setting and laparoscopic sterilization using the tubal ligation system as a day-case under general anesthesia. Outcome data were collected regarding feasibility (technical completion of the sterilization procedure, satisfactory radiological confirmation at 3 months-hysterosalpingogram or transvaginal pelvic ultrasound scan), safety events within 30 days of procedures, reoperations, and unintended pregnancies within 1 year of procedures. RESULTS: Hysteroscopic sterilization was successful in 992/1085 (91.4%; 95% confidence interval, 89.6-93.0%) at the first attempt. In comparison, bilateral tubal ligation was successfully performed in 2400/2412 (99.5%; 95% confidence interval, 99.2-99.8%) of patients who underwent laparoscopic sterilizations (odds ratio, 18.8; 95% confidence interval, 10.2-34.4). In all, 902/1085 (83.1%; 95% confidence interval, 80.8-85.2%) of successfully performed hysteroscopic procedures attended for radiological confirmation testing were considered satisfactory. The rate of adverse events within 30 days were similar: 2/1085 (0.2%) vs 3 (0.12%; 95% confidence interval, 0.04-0.36%). There were 3/1085 (0.3%; 95% confidence interval, 0.1-0.8%) unintended pregnancies after hysteroscopic sterilization compared with 5/2412 (0.2%; 95% confidence interval, 0.1-0.5%) laparoscopic sterilization (odds ratio, 1.3; 95% confidence interval, 0.3-5.6). Median length of follow-up for pregnancy outcome was 5 years. Hysteroscopic sterilization was associated with a higher risk of reoperation at 1 year compared to laparoscopic sterilization (odds ratio, 6.2; 95% confidence interval, 2.8-14.0) and the commonest reintervention was unilateral salpingectomy (12/22, 54.5%). CONCLUSION: Hysteroscopic sterilization has been introduced as a more convenient, office-based method of permanent fertility control. However, while the small risk of unintended pregnancy is comparable to conventional laparoscopic sterilization, women should also be counselled regarding its lower success rate in successfully completing the procedure and its higher rate of failed reoperation.