The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy

OBJECTIVE: To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. DESIGN: Two parallel, multicentre, randomised trials. Setting 28 UK centres and two South African centres. Participants 1380 women were recruited; 1346 had surgery; 937 were followed up at one year. PRIMARY OUTCOME: outcome Rate of major complications. RESULTS: In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, − 5.2% to 5.8%), and the number needed to treat to harm was 333.We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. CONCLUSIONS: Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time

Cost effectiveness analysis of laparoscopic hysterectomy compared with standard hysterectomy: results from a randomised trial

Objective: To assess the cost effectiveness of laparoscopic hysterectomy compared with conventional hysterectomy (abdominal or vaginal). Design: Cost effectiveness analysis based on two parallel trials: laparoscopic (n = 324) compared with vaginal hysterectomy (n = 163); and laparoscopic (n = 573) compared with abdominal hysterectomy (n = 286). Participants: 1346 women requiring a hysterectomy for reasons other than malignancy. Main outcome measure: One year costs estimated from NHS perspective. Health outcomes expressed in terms of QALYs based on women's responses to the EQ-5D at baseline and at three points during up to 52 weeks' follow up. Results: Laparoscopic hysterectomy cost an average of pound401 ($708; C571) more (95$471789; E380 437). The, probability that laparoscopic hysterectomy is cost effective was below 50% for a large range of values of willingness to pay for an additional QALY. Laparoscopic hysterectomy cost an average of pound186 ($328; E265) more than abdominal hysterectomy, although 95$46 893; E37 813). If the NHS is willing to pay pound30 0 00 for an additional QALY, the probability that laparoscopic hysterectomy is cost effective is 56%. Conclusions: Laparoscopic hysterectomy is not cost effective relative to vaginal hysterectomy. Its cost effectiveness relative to the abdominal procedure is finely balanced

The association between hysterectomy and ovarian cancer risk: A population-based record-linkage study

Background: Recent studies have called into question the long-held belief that hysterectomy without oophorectomy protects against ovarian cancer. This population-based longitudinal record-linkage study aimed to explore this relationship, overall and by age at hysterectomy, time period, surgery type, and indication for hysterectomy. Methods: We followed the female adult Western Australian population (837 942 women) across a 27-year period using linked electoral, hospital, births, deaths, and cancer records. Surgery dates were determined from hospital records, and ovarian cancer diagnoses (n¼1640) were ascertained from cancer registry records.We used Cox regression to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for the association between hysterectomy and ovarian cancer incidence. Results: Hysterectomy without oophorectomy (n¼78 594) was not associated with risk of invasive ovarian cancer overall (HR ¼ 0.98, 95% CI ¼ 0.85 to 1.11) or with the most common serous subtype (HR ¼ 1.05, 95% CI ¼ 0.89 to 1.23). Estimates did not vary statistically significantly by age at procedure, time period, or surgical approach. However, among women with endometriosis (5.8%) or with fibroids (5.7%), hysterectomy was associated with substantially decreased ovarian cancer risk overall (HR ¼ 0.17, 95% CI ¼ 0.12 to 0.24, and HR ¼ 0.27, 95% CI ¼ 0.20 to 0.36, respectively) and across all subtypes. Conclusions: Our results suggest that for most women, having a hysterectomy with ovarian conservation is not likely to substantially alter their risk of developing ovarian cancer. However, our results, if confirmed, suggest that ovarian cancer risk reduction could be considered as a possible benefit of hysterectomy when making decisions about surgical management of endometriosis or fibroids

Endovascular management of massive post-partum haemorrhage in abnormal placental implantation deliveries

Objectives: To retrospectively evaluate safety and efficacy of pelvic artery embolisation (PAE) in post-partum haemorrhage (PPH) in abnormal placental implantation (API) deliveries. Methods: From January 2009 to November 2013, 12 patients with API and intractable intraoperative PPH underwent PAE after caesarean delivery to control a haemorrhage (in four of these cases after hysterectomy). Arterial access was obtained prior to the delivery; PAE was performed in the obstetrics operating room by an interventional radiologist that was present with an interventional radiology (IR) team during the delivery. Results: PAE was successful in preventing bleeding and avoid hysterectomy in four cases (group A). Uterine atony and disseminated intravascular coagulation caused failure of PAE requiring hysterectomy in four patients (group B). PAE prevented bleeding post-hysterectomy in the remaining four cases (group C). Technical success (cessation of contrast extravasation on angiography or occlusion of the selected artery) was 100 %. Maternal and foetal mortality and morbidity were 0 %. Conclusions: PAE is a minimal invasive technique that may help to prevent hysterectomy and control PPH in API pregnancies without complications. Embolisation should be performed on an emergency basis. For such cases, an IR team on standby in the obstetrics theatre may be useful to prevent hysterectomy, blood loss and limit morbidity. Key Points: • Endovascular treatment is a validated technique in post-partum haemorrhage. • Abnormal placental implantation is a risk factor for post-partum haemorrhage. • We propose an interventional radiologist standby in the delivery room. © 2015, European Society of Radiology

Clinical Diagnosis of Placenta Accreta and Clinicopathological Outcomes

Objective To investigate the association between the intraoperative diagnosis of placenta accreta at the time of cesarean hysterectomy and pathological diagnosis. Study Design This is a retrospective cohort study of all patients undergoing cesarean hysterectomy for suspected placenta accreta from 2000 to 2016 at Barnes-Jewish Hospital. The primary outcome was the presence of invasive placentation on the pathology report. We estimated predictive characteristics of clinical diagnosis of placenta accreta using pathological diagnosis as the correct diagnosis. Results There were 50 cesarean hysterectomies performed for suspected abnormal placentation from 2000 to 2016. Of these, 34 (68%) had a diagnosis of accreta preoperatively and 16 (32%) were diagnosed intraoperatively at the time of cesarean delivery. Two patients had no pathological evidence of invasion, corresponding to a false-positive rate of 4% (95% confidence interval [CI]: 0.5%, 13.8%) and a positive predictive value of 96% (95% CI: 86.3%, 99.5%). There were no differences in complications among patients diagnosed intraoperatively compared with those diagnosed preoperatively. Conclusion Most patients undergoing cesarean hysterectomy for placenta accreta do have this diagnosis confirmed on pathology. However, since the diagnosis of placenta accreta was made intraoperatively in nearly a third of cesarean hysterectomies, intraoperative vigilance is required as the need for cesarean hysterectomy may not be anticipated preoperatively

Hysterectomy, endometrial ablation, and levonorgestrel releasing intrauterine system (Mirena) for treatment of heavy menstrual bleeding : cost effectiveness analysis

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Effects of abdominal and vaginal hysterectomy on anorectal functions along with quality of life of the patient

Objectives and background:Hysterectomy is the most commonly performed major gynecological operation for both benign and malign gynecologic conditions. After hysterectomy, although some investigators have declared an increased incidence of urinary and anorectal dysfunction, some others could not show any connection. Methods: The voluntary patients were divided in two groups: abdominal hysterectomy (Group 1) and vaginal hysterectomy (Group 2). Anal manometry and all the other examinations of the patients were performed at the Department of General Surgery Endoscopy Unit of Ankara University, Faculty of Medicine. Results: When the quality of life of the patients was assessed before the operation and on the 12 th post-operative month via the SF-36 form; it can be seen that body pain parameters of the patients in Group 1 had significantly improved and there is no statistical difference in other parameters. When the effect of hysterectomy on the quality of life of the patients was evaluated by the “Cleveland Clinic Global Quality of Life” form, the statistically significant improvement in the quality of life of the patients in Group 2 was observed. Conclusion: If the type of operation (vaginal or abdominal) is performed due to benign causes, it does not affect the urinary and anorectal functions of the patients. Depending on the decrease of complaints of the patients, it has a positive effect on the quality of life. © 2018 Birsen et al

Emergency peripartum hysterectomy, physical and mental consequences: a 6-year study

Emergency peripartum hysterectomy (EPH) is performed for massive postpartum hemorrhage following a cesarean delivery or vaginal delivery, in order to save the patient’s life. The current study was performed on a sample of 13.162 patients, which underwent cesarean or vaginal delivery during a period of 6 years, from 2010 to 2015, in Bucur Maternity Hospital. There were two subsequential groups consisting in: 6593 patients with cesarean operations and 6569 patients with vaginal delivery. In 12 cases occurred one or more of the risk factors that lead to EPH, divided equally across the two groups above. The main two types of surgery are a more frequent subtotal hysterectomy, which is the preferred type of EPH as it takes less time and is associated with fewer complications, and a total hysterectomy. The majority of procedures were performed at patients over 35 years old (9 of 12), with a median age of 31,16 (ranging from 21 to 44 years old). The most important risk factor present across the lot was multiparity (11 from 12), with cicatricial uterus being the second one (4 of 12). ICU median time was 4,5 days (ranging from 3 to 15 days), with a median blood transfusion necessity of around 2,4 I.U per patient. There were no mother or newborn reported deaths, neither PTSD following EPH.EPH is a procedure performed as last-resort, life-saving surgery, leaving no time for mental preparation of the patients. This may predispose to negative psychological outcomes, especially because they are not part of decision-making process due to the emergency character of hysterectomy

Hysterectomy, endometrial destruction, and levonorgestrel releasing intrauterine system (Mirena) for heavy menstrual bleeding : systematic review and meta-analysis of data from individual patients

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