BACKGROUND: The four approaches to hysterectomy for benign disease are abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH) and robotic-assisted hysterectomy (RH). OBJECTIVES: To assess the effectiveness and safety of different surgical approaches to hysterectomy for women with benign gynaecological conditions. SEARCH METHODS: We searched the following databases (from inception to 14 August 2014) using the Ovid platform: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycINFO. We also searched relevant citation lists. We used both indexed and free-text terms. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in which clinical outcomes were compared between one surgical approach to hysterectomy and another. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected trials, assessed risk of bias and performed data extraction. Our primary outcomes were return to normal activities, satisfaction, quality of life, intraoperative visceral injury and major long-term complications (i.e. fistula, pelvi-abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition and sexual dysfunction). MAIN RESULTS: We included 47 studies with 5102 women. The evidence for most comparisons was of low or moderate quality. The main limitations were poor reporting and imprecision. Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH) (nine RCTs, 762 women)Return to normal activities was shorter in the VH group (mean difference (MD) -9.5 days, 95% confidence interval (CI) -12.6 to -6.4, three RCTs, 176 women, I(2) = 75%, moderate quality evidence). There was no evidence of a difference between the groups for the other primary outcomes. Laparoscopic hysterectomy (LH) versus AH (25 RCTs, 2983 women)Return to normal activities was shorter in the LH group (MD -13.6 days, 95% CI -15.4 to -11.8; six RCTs, 520 women, I(2) = 71%, low quality evidence), but there were more urinary tract injuries in the LH group (odds ratio (OR) 2.4, 95% CI 1.2 to 4.8, 13 RCTs, 2140 women, I(2) = 0%, low quality evidence). There was no evidence of a difference between the groups for the other primary outcomes. LH versus VH (16 RCTs, 1440 women)There was no evidence of a difference between the groups for any primary outcomes. Robotic-assisted hysterectomy (RH) versus LH (two RCTs, 152 women)There was no evidence of a difference between the groups for any primary outcomes. Neither of the studies reported satisfaction rates or quality of life.Overall, the number of adverse events was low in the included studies. AUTHORS' CONCLUSIONS: Among women undergoing hysterectomy for benign disease, VH appears to be superior to LH and AH, as it is associated with faster return to normal activities. When technically feasible, VH should be performed in preference to AH because of more rapid recovery and fewer febrile episodes postoperatively. Where VH is not possible, LH has some advantages over AH (including more rapid recovery and fewer febrile episodes and wound or abdominal wall infections), but these are offset by a longer operating time. No advantages of LH over VH could be found; LH had a longer operation time, and total laparoscopic hysterectomy (TLH) had more urinary tract injuries. Of the three subcategories of LH, there are more RCT data for laparoscopic-assisted vaginal hysterectomy and LH than for TLH. Single-port laparoscopic hysterectomy and RH should either be abandoned or further evaluated since there is a lack of evidence of any benefit over conventional LH. Overall, the evidence in this review has to be interpreted with caution as adverse event rates were low, resulting in low power for these comparisons. The surgical approach to hysterectomy should be discussed and decided in the light of the relative benefits and hazards. These benefits and hazards seem to be dependent on surgical expertise and this may influence the decision. In conclusion, when VH is not feasible, LH may avoid the need for AH, but LH is associated with more urinary tract injuries. There is no evidence that RH is of benefit in this population. Preferably, the surgical approach to hysterectomy should be decided by the woman in discussion with her surgeon.

/pdf/surgical-approach-to-hysterectomy-for-benign-gynaecological-55zzlqsjex.pdf

Surgical approach to hysterectomy for benign gynaecological disease.

Critical care in pregnancy is a field that remains unevenly researched. Although there is a body of evidence to guide many recommendations in critical care, limited research specifically addresses obstetric critical care. The purpose of this document is to review the available evidence, propose strategies for care, and highlight the need for additional research. Much of the review will, of necessity, focus on general principles of critical care, extrapolating where possible to obstetric critical care.

/pdf/acog-practice-bulletin-2e7yp8vork.pdf

Acog practice bulletin

von Willebrand disease (VWD) is a commonly encountered inherited bleeding disorder affecting both males and females, causing mucous membrane and skin bleeding symptoms, and bleeding with surgical or other haemostatic challenges. VWD may be disproportionately symptomatic in women of child-bearing age. It may also occur less frequently as an acquired disorder (acquired von Willebrand syndrome). VWD is caused by deficiency or dysfunction of von Willebrand factor (VWF), a plasma protein that mediates platelet haemostatic function and stabilizes blood coagulation factor VIII. The pathophysiology, classification, diagnosis and management of VWD are relatively complex, but understanding them is important for proper diagnosis and management of patients with VWD. These evidence-based guidelines for diagnosis and management of VWD from the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel (USA) review relevant publications, summarize current understanding of VWD pathophysiology and classification, and present consensus diagnostic and management recommendations based on analysis of the literature and expert opinion. They also suggest an approach for clinical and laboratory evaluation of individuals with bleeding symptoms, history of bleeding or conditions associated with increased bleeding risk. This document summarizes needs for further research in VWF, VWD and bleeding disorders, including clinical research to obtain more objective information about bleeding symptoms, advancements in diagnostic and therapeutic tools, and enhancement in the education and training of clinicians and scientists in bleeding and thrombotic disorders. The NHLBI Web site (http://www.nhlbi.nih.gov/guidelines/vwd) has a more detailed document, a synopsis of these recommendations, and patient education information.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1365-2516.2007.01643.x

von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA).

In trial-based cost-effectiveness analysis baseline mean utility values are invariably imbalanced between treatment arms. A patient's baseline utility is likely to be highly correlated with their quality-adjusted life-years (QALYs) over the follow-up period, not least because it typically contributes to the QALY calculation. Therefore, imbalance in baseline utility needs to be accounted for in the estimation of mean differential QALYs, and failure to control for this imbalance can result in a misleading incremental cost-effectiveness ratio. This paper discusses the approaches that have been used in the cost-effectiveness literature to estimate absolute and differential mean QALYs alongside randomised trials, and illustrates the implications of baseline mean utility imbalance for QALY calculation. Using data from a recently conducted trial-based cost-effectiveness study and a micro-simulation exercise, the relative performance of alternative estimators is compared, showing that widely used methods to calculate differential QALYs provide incorrect results in the presence of baseline mean utility imbalance regardless of whether these differences are formally statistically significant. It is demonstrated that multiple regression methods can be usefully applied to generate appropriate estimates of differential mean QALYs and an associated measure of sampling variability, while controlling for differences in baseline mean utility between treatment arms in the trial.

Estimating mean QALYs in trial-based cost-effectiveness analysis : the importance of controlling for baseline utility

OBJECTIVES To review, and to develop further, the methods used to assess and to increase the generalisability of economic evaluation studies. DATA SOURCES Electronic databases. REVIEW METHODS Methodological studies relating to economic evaluation in healthcare were searched. This included electronic searches of a range of databases, including PREMEDLINE, MEDLINE, EMBASE and EconLit, and manual searches of key journals. The case studies of a decision analytic model involved highlighting specific features of previously published economic studies related to generalisability and location-related variability. The case-study involving the secondary analysis of cost-effectiveness analyses was based on the secondary analysis of three economic studies using data from randomised trials. RESULTS The factor most frequently cited as generating variability in economic results between locations was the unit costs associated with particular resources. In the context of studies based on the analysis of patient-level data, regression analysis has been advocated as a means of looking at variability in economic results across locations. These methods have generally accepted that some components of resource use and outcomes are exchangeable across locations. Recent studies have also explored, in cost-effectiveness analysis, the use of tests of heterogeneity similar to those used in clinical evaluation in trials. The decision analytic model has been the main means by which cost-effectiveness has been adapted from trial to non-trial locations. Most models have focused on changes to the cost side of the analysis, but it is clear that the effectiveness side may also need to be adapted between locations. There have been weaknesses in some aspects of the reporting in applied cost-effectiveness studies. These may limit decision-makers' ability to judge the relevance of a study to their specific situations. The case study demonstrated the potential value of multilevel modelling (MLM). Where clustering exists by location (e.g. centre or country), MLM can facilitate correct estimates of the uncertainty in cost-effectiveness results, and also a means of estimating location-specific cost-effectiveness. The review of applied economic studies based on decision analytic models showed that few studies were explicit about their target decision-maker(s)/jurisdictions. The studies in the review generally made more effort to ensure that their cost inputs were specific to their target jurisdiction than their effectiveness parameters. Standard sensitivity analysis was the main way of dealing with uncertainty in the models, although few studies looked explicitly at variability between locations. The modelling case study illustrated how effectiveness and cost data can be made location-specific. In particular, on the effectiveness side, the example showed the separation of location-specific baseline events and pooled estimates of relative treatment effect, where the latter are assumed exchangeable across locations. CONCLUSIONS A large number of factors are mentioned in the literature that might be expected to generate variation in the cost-effectiveness of healthcare interventions across locations. Several papers have demonstrated differences in the volume and cost of resource use between locations, but few studies have looked at variability in outcomes. In applied trial-based cost-effectiveness studies, few studies provide sufficient evidence for decision-makers to establish the relevance or to adjust the results of the study to their location of interest. Very few studies utilised statistical methods formally to assess the variability in results between locations. In applied economic studies based on decision models, most studies either stated their target decision-maker/jurisdiction or provided sufficient information from which this could be inferred. There was a greater tendency to ensure that cost inputs were specific to the target jurisdiction than clinical parameters. Methods to assess generalisability and variability in economic evaluation studies have been discussed extensively in the literature relating to both trial-based and modelling studies. Regression-based methods are likely to offer a systematic approach to quantifying variability in patient-level data. In particular, MLM has the potential to facilitate estimates of cost-effectiveness, which both reflect the variation in costs and outcomes between locations and also enable the consistency of cost-effectiveness estimates between locations to be assessed directly. Decision analytic models will retain an important role in adapting the results of cost-effectiveness studies between locations. Recommendations for further research include: the development of methods of evidence synthesis which model the exchangeability of data across locations and allow for the additional uncertainty in this process; assessment of alternative approaches to specifying multilevel models to the analysis of cost-effectiveness data alongside multilocation randomised trials; identification of a range of appropriate covariates relating to locations (e.g. hospitals) in multilevel models; and further assessment of the role of econometric methods (e.g. selection models) for cost-effectiveness analysis alongside observational datasets, and to increase the generalisability of randomised trials.

Generalisability in economic evaluation studies in healthcare: a review and case studies.

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 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 = 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.

https://www.bmj.com/content/bmj/328/7432/129.full.pdf

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

Six hundred endometrial laser ablations

Risk of hysterectomy after 1000 consecutive endometrial laser ablations

Objective

To determine how much gas is required for initial insufflation of the abdomen at laparoscopy.



Design

A prospective observational study.



Setting

Specialized minimal access gynaecological operating theatre in a district general hospital.



Subjects

43 female patients undergoing laparoscopy.



Interventions

In 30 patients, changes in the vertical depth of the pneumoperitoneum at the umbilicus were measured when the volume and pressure of the insufflated CO2 was changed. The depth was also measured in response to changes in the downward force applied to the umbilicus with insertion of the primary cannula. Non-invasive monitoring of respiratory and circulatory parameters was carried out on a further 13 patients during these procedures and with variation in head-down tilt.



Main outcome measures

The vertical depth of the pneumoperitoneum, and cardiovascular and respiratory parameters.



Results

When a downward force of 3 kg force is applied at the umbilicus, the mean vertical depth of the pneumoperitoneum is only 0.6 cm (the range includes zero) when the intra-abdominal pressure is 10 mmHg (approximately equivalent to insufflation of 3 l CO2). This increases to 5.6 cm (range 4–8) when the intra-abdominal pressure is raised to 25 mmHg. The mean volume of CO2 required to achieve a pressure of 25 mmHg is 5.58 l (range 3.7–11.1). The maximum respiratory effects of the 25-mmHg intra-abdominal pressure (with the patient flat) are no greater than the effect of the Trendelenburg position with an intra-abdominal pressure of 15 mmHg. No adverse circulatory effects are demonstrated.



Conclusions

This 25-mmHg pressure-limited method produces a greater splinting of the abdominal wall and a deeper gas bubble than the traditional volume-limited pneumoperitoneum of 2–3 l, which should lead to a reduced risk of injury.

How much gas is required for initial insufflation at laparoscopy

A randomised controlled trial comparing the Cavaterm endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding

Graham Phillips

Papers

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

Six hundred endometrial laser ablations

Risk of hysterectomy after 1000 consecutive endometrial laser ablations

How much gas is required for initial insufflation at laparoscopy

A randomised controlled trial comparing the Cavaterm endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding