Episcissors-60 for mediolateral episiotomy

The committee noted that the evidence for clinical benefit with reusable Episcissors‑60 is uncertain. Published evidence and the opinions of experts indicate that they are easy to use. But their impact on the incidence of obstetric anal sphincter injuries (OASI) after episiotomy is uncertain. The clinical experts explained that several factors make an injury more likely. The committee noted that some of the studies introduced reusable Episcissors‑60 at the same time as a care bundle of other measures of optimal care to reduce the risk of OASI. The evidence shows that when these studies are excluded from a pooled analysis, there was no difference in the incidence of OASI between women who had episiotomies using reusable Episcissors‑60 and standard scissors. Given this, as well as the low quality and heterogenous nature of the studies available, the committee concluded that the impact of reusable Episcissors‑60 alone on OASI rates could not be determined with certainty on the basis of the current evidence, and further research is needed.

The committee noted that all of the published studies used the reusable Episcissors‑60. The company stated that the differences between the 2 versions are that reusable Episcissors-60 have gold handles and tungsten carbide blades. These components are not in the single-use disposable version. The committee considered that the evidence cannot be extrapolated to the single-use disposable version. The committee concluded, therefore, that further evidence assessing the relative merits of the single-use disposable Episcissors‑60 compared with standard scissors is also needed.

The clinical experts explained that the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists (RCOG) published a list of evidence-based measures in 2017 to reduce the risk of OASI (the OASI care bundle). These have been incorporated since then across the NHS as part of routine care. These measures are instituted before, during and after birth and include:

• providing antenatal information to women

• performing a mediolateral episiotomy when indicated at 60 degrees at crowning

• using manual perineal protection during all vaginal births

• doing a perineal examination (including a per rectum examination) after childbirth.

The RCOG's Third- and fourth-degree perineal tears, management (green-top guideline no. 29) provides different evidence-based guidance to aid good clinical practice in the diagnosis, management and treatment of OASI, including:

• providing information to women that the evidence for the protective effect of episiotomy is conflicting

• considering the use of mediolateral episiotomy in instrumental deliveries

• performing mediolateral episiotomies at 60 degrees away from the midline when the perineum is distended.
  
  The guidance also states that perineal protection at crowning can be protective and warm compression during the second stage of labour reduces the risk of OASI.

The experts explained that, if implemented, Episcissors‑60 would be used for the episiotomy as part of the standard RCOG OASI care bundle to reduce the incidence of OASI. The committee proposed that further evidence exploring the possible benefits of using Episcissors‑60 compared with standard episiotomy scissors, in addition to the standard bundle of care, is needed to identify any additional incremental clinical benefits.

The external assessment centre (EAC) considered that the evidence reporting a longer episiotomy cut with reusable Episcissors‑60 than with standard scissors is limited and of poor quality. The company stated that reusable and single-use disposable Episcissors‑60 have a blade length of 5 cm, and this is the same as for standard scissors. The clinical experts noted that the length of cut using standard scissors may be reduced by using less of the blade, allowing clinicians to make as small a cut as is needed. The experts were unsure if this would also be possible in a reliable way using Episcissors‑60, and stated that the ability to alter the length of the cut may depend on clinical experience. The committee concluded that the length of the episiotomy incision should be addressed in future studies.

One study reported an increase in estimated delivery blood loss of approximately 50 ml per use after reusable Episcissors‑60 were introduced. One clinical expert, who was involved in the trial, explained that this outcome was added to the study after anecdotal reports from clinicians that using reusable Episcissors‑60 appeared to be associated with an increase in blood loss and a need for earlier suturing in some cases to seal bleeding points. The clinical expert was unsure about the clinical significance of this level of increased blood loss. The clinical expert also explained that estimating blood loss under these clinical circumstances is difficult and that the different centres involved in the study measured it differently. The EAC noted that this was not a predetermined outcome in the study in question and that blood loss is not reported as an outcome in any of the other studies. The committee concluded therefore that this finding should be interpreted with caution but is something that could be explored further in future studies.

The clinical experts explained that angle of incision to the midline at the time of delivery does not always correlate closely with the post-delivery suture angle because of the anatomical distension that results from the passage of the baby at the time of the episiotomy. Furthermore, they explained that in addition to the episiotomy angle, there are a number of other important factors which influence the rate of OASI. These include the timing and speed of delivery, the perineal body length, and whether the mother has given birth before. The committee concluded therefore that the post-delivery suture angle alone cannot be regarded as a reliable surrogate for either the risk or outcome of an OASI.

The clinical experts explained that, although there is a clear written definition of different levels of OASI, in practice it is subjective and often difficult to determine. The clinical experts highlighted that it is particularly difficult to differentiate between a 3b and 3c degree tear. This may be one compounding factor that influences the heterogenous rates of OASI in different populations and studies.

A number of equalities considerations are relevant to the risk of OASI. Older women, women with a short perineal body length (such as those of Asian family origin), and women who have undergone female genital mutilation may be at increased risk of OASI (although the last is uncertain from the evidence available). The clinical experts explained that women at higher risk of OASI may need an earlier episiotomy. Age, sex, pregnancy, race and disability are protected characteristics under the Equality Act 2010. The committee concluded that research is needed in those at greatest risk to address potential equality considerations.

There is currently no evidence reporting the experiences of women who have had an episiotomy using Episcissors‑60, even though OASI repair may impact sexual function and quality of life. The committee concluded that patient-reported outcome measures, including patient-reported experience measures to assess the impact of the process of care on the patient's experience, should be included in future research to assess the impact of Episcissors‑60.

The company stated that disposable Episcissors‑60 are discarded after a single use and cannot be recycled. Because of this the committee and experts raised concern about the sustainability of the technology and a possible negative environmental impact.

The clinical experts said there may be wastage when Episcissors‑60 are opened in preparation for an episiotomy but not then used. Experts estimated that wastage of Episcissors‑60 is most likely with midwife-supervised spontaneous vaginal deliveries. Experts thought that if Episcissors‑60 were opened for all spontaneous births in preparation for a possible episiotomy, but the women delivered spontaneously, then wastage would result. On the other hand, the need for an episiotomy is more predictable when an obstetrician performs an operative vaginal delivery, meaning that wastage may be less likely. The EAC stated that the problem of wastage is more relevant with single-use disposable Episcissors‑60 (which would need to be thrown away once opened) rather than reusable Episcissors-60 (which could then be resterilised).

In one clinical expert's hospital, a training package was delivered at the same time as introducing Episcissors‑60, which included doing episiotomies on a dummy. Experts stated that this training increased midwives' confidence in doing episiotomies. The experts emphasised, however, the importance of focusing training on optimal episiotomy practice in the context of a wider bundle of measures to minimise the risk of OASIs.

Two studies report favourable data on how easy it is to use reusable Episcissors‑60, but they are poor quality. The clinical experts were divided on their experiences and those of their colleagues about how easy it is to use Episcissors‑60. Midwives were identified by some as the most supportive professional group of Episcissors‑60 but opinion among obstetricians is mixed.

There is some evidence to suggest that introducing Episcissors‑60 may increase the rate of episiotomy, but the quality of this evidence is poor. The clinical experts explained that, if episiotomy rates are increased, this may be because of increased staff confidence in doing episiotomies, and because of introducing the OASI care bundle. The clinical experts acknowledged that there is no consensus on what best-practice episiotomy rates should be either in spontaneous or operative vaginal delivery.

The clinical experts said it was difficult to be certain about how an OASI affects length of hospital stay. They explained that there are several factors that affect length of stay after delivery, including the method of delivery and severity of OASI, as well as those relating to establishing feeding and wellbeing for the newborn baby and mother. Experts explained that women with fourth-degree tears stay in hospital longer than those with third-degree tears. One expert stated that women who have a spontaneous vaginal delivery and an OASI stay overnight, whereas women with uncomplicated spontaneous vaginal deliveries are normally discharged the same day. Women who have had an operative vaginal delivery normally stay in hospital overnight even in the absence of an OASI, so an increase in length of stay may not be a consequence of the OASI itself in these women.

The committee considered that, because of the uncertainties about the possible clinical benefit of Episcissors‑60, it was difficult to draw firm conclusions about any cost benefits. The committee concluded that further evidence is needed to show if reusable and single-use disposable Episcissors‑60 lead to cost savings when compared with using standard scissors.

The committee considered the factors that are likely to be important in determining the cost impact of Episcissors‑60. The EAC identified the key driver in the cost model to be the OASI rate in the comparator, standard scissors arm. The lower the rate of baseline OASI, the less of an impact introducing Episcissors‑60 can have on the rates of OASI, and the potential for cost savings. The clinical experts discussed how the rate of OASI varies depending on the population studied and its different demographics. The committee concluded that more robust evidence is needed that includes these important considerations to better understand the cost impact of using single-use disposable Episcissors‑60 in the NHS.

The EAC's revised cost model showed that over 1 year, compared with standard episiotomy scissors (based on a cost per use of reusable episiotomy scissors), Episcissors‑60 are associated with a cost saving of around £30.70 per patient. In an EAC scenario analysis, the cost of standard scissors was increased to reflect a possible higher cost of single-use disposable standard scissors. This increased the incremental cost saving to £34.44 per patient. The cost of standard scissors cannot be reported because this cost is considered confidential by NHS Supply Chain. Further detail can be obtained by contacting NHS Supply Chain.

The clinical experts said that uncertainties in the evidence and the higher cost of reusable Episcissors‑60 compared with standard scissors have affected the adoption of the device. The committee considered that the EAC may have underestimated the cost of an OASI repair in their model. The EAC confirmed that NHS reference costs for perineal trauma were used, but long-term costs associated with OASI, including managing faecal incontinence, are not accounted for in the EAC's model. The EAC and experts agree that there may be additional long-term costs to the NHS of managing patients with OASI including the need for additional therapies and social care. The committee suggested that the time horizon for future studies and cost estimates should be sufficiently long to capture these important aspects of holistic care. One clinical expert thought that the cost of a caesarean section should also be included because some women may elect to have this as an alternative to accepting the possible consequences of an OASI complication of a vaginal delivery.

The committee concluded that further research is needed to address uncertainties about the safety and efficacy of Episcissors‑60. This research should be sufficiently robust in design and implementation to determine if Episcissors‑60, in addition to an OASI care bundle, adds clinical value compared with using standard episiotomy scissors and visual assessment of the cutting angle in addition to an OASI care bundle. It was the opinion of the experts that a randomised controlled trial would be ethical and feasible to do. Trials would need to ensure that optimal bundles of clinical care to reduce OASI risk were defined and applied equally to both intervention and comparator arms and that OASI rates, length of hospital stay, incision length and blood loss, patient-reported outcome measures, and cost analysis were included. Studies should include women who have not given birth before, women having an operative vaginal delivery, and women of Asian family origin to ensure that equalities considerations are addressed. The research should provide data to inform cost modelling and should be designed within a timeframe to provide useful information before this guidance is reviewed.