Introduction

An episiotomy is a procedure performed during labour, in which a woman's vaginal wall and perineum (the area between the vagina and anus) are cut in order to allow the baby to pass through the vagina more easily. In 2011 to 2012, 15.2% (101,678) of all births in England needed an episiotomy (HESonline).

An episiotomy is done under local anaesthetic using standard episiotomy scissors. Episiotomies can be done medially (straight down the midline from the vagina to the anus), mediolaterally (between the midline and the lateral line) or laterally (perpendicular to the midline) using straight scissors, or can be 'J‑shaped' using curved scissors (curving away from the anus). Most episiotomies are done mediolaterally towards the woman's right hand side, from the posterior vaginal fourchette (a fork‑shaped fold of skin at the bottom of the entrance to the vagina; Kalis et al. 2012).

NICE's guideline on intrapartum care recommends that an episiotomy should only be done if there is a clinical need, such as when instruments are used during birth or where there is suspected foetal compromise. Routine episiotomy is not recommended in the following circumstances:

  • during spontaneous vaginal birth

  • after third‑degree trauma from previous childbirth (injury to perineum involving the anal sphincter complex)

  • after fourth‑degree trauma from previous childbirth (injury to perineum involving the anal sphincter complex and anal epithelium).

Both NICE's guideline on intrapartum care and the Royal College of Obstetricians and Gynaecologists (RCOG) guideline on the management of perineal tears recommend that if episiotomy is indicated, a mediolateral episiotomy should be done. This should originate at the vaginal fourchette and usually be directed towards the right side. The RCOG guideline specifically recommends that the angle of the episiotomy cut should be at 60 degrees to the midline (where an angle of 0 degrees would point directly from the vagina to the anus), cutting diagonally from the vagina towards the woman's right side and the back of her body. It is also recommended that pain relief (such as local anaesthetic) should be provided before an episiotomy, except in an emergency involving acute foetal compromise. The RCOG guideline identifies the Episcissors‑60 as a specific tool for cutting the episiotomy at a 60 degree angle.

Studies have demonstrated that, where clinically indicated, mediolateral episiotomy can protect against obstetric anal sphincter injuries (OASIs). However, the cutting angle is important. If the cutting angle is less than 45 degrees to the perineal midline, there is a higher risk of OASIs (Kalis 2008). Cutting angles greater than 60 degrees to the perineal midline have been shown to be ineffective, because they do not relieve the pressure on the perineum (Stedenfeldt et al. 2012).

OASIs can occur during vaginal delivery when a severe perineal tear causes the anal sphincter to rupture. OASIs are the most common cause of faecal incontinence in otherwise healthy women. They occur in 2.9% of births in the UK overall, in 6.1% of first‑time births and 1.7% of births to women who have given birth 2 or more times before (Thiagamoorthy et al. 2014).

A meta‑analysis found that 30% of women who had an OASI still had symptoms 1 year after childbirth (Oberwalder 2003). Symptoms can include faecal urgency, inability to control wind and uncontrolled bowel movements (Dudding et al. 2008).

OASIs are usually repaired within 24 hours of delivery under general or regional anaesthesia in an operating theatre. The use of broad‑spectrum antibiotics is recommended following OASI repair, to lower the incidence of post‑operative infections and wound opening. According to the RCOG guidelines, women with OASI symptoms should be referred to a specialist centre or a colorectal surgeon. Management strategies for faecal incontinence range from incontinence pads to sacral nerve stimulation and can also include provision of psychological and emotional support. The NICE costing report produced for its guideline on faecal incontinence estimates the initial cost of OASI repair to be £1289 per person, excluding imaging and outpatient follow‑up.

Episiotomies done at a 60‑degree angle to the perineal midline at the time of crowning have been shown to be associated with a lower rate of OASIs compared with episiotomies done at an angle of 40 degrees (Kalis et al. 2011). Due to distension of the perineum during childbirth, the angle of the episiotomy at the time it is cut is different to the angle as viewed after birth. The cutting angle becomes more acute (that is, closer to the anus) after birth, and the closer the episiotomy is to the anal sphincter after delivery, the higher the potential risk of anal sphincter damage. A study by Kalis et al. (2008) showed that a cutting angle which appeared to be at 40 degrees to the perineal midline before delivery may in fact equate to a post‑delivery suture angle of 22 degrees. Therefore, in order to ensure that a truly mediolateral post‑delivery angle of 45 degrees is achieved, it is necessary to cut a 60‑degree episiotomy (Kalis et al. 2011).

About the technology

CE marking

The Episcissors‑60 are a Class I medical device made by 2 separate manufacturers:

  • Lawton Medizintechnik, which first CE‑marked the device in February 2014 with current declaration of conformity valid until August 2017.

  • Jaho Medizintechnik, which first CE‑marked the device in June 2014 with current declaration of conformity valid until December 2015.

Medinvent supplies the Episcissors‑60 in the UK.

Description

The Episcissors‑60 are adapted surgical scissors made from stainless steel with 5‑centimetre long tungsten carbide cutting blades. The device has a guide‑limb angled at 60 degrees to the blades, mounted on the blade pivot point. During use, the guide-limb is positioned by the clinician to be vertically in line with the perineal midline and pointing towards the anus to ensure an episiotomy cutting angle of 60 degrees. The guide limb is flexible to accommodate the baby's head at crowning and maintain the cutting guide position. Two versions of the device are available, based on operator preference:

  • A straight version with blades in line with the handles, designed to give an incision point directly at the posterior vaginal fourchette.

  • An angled version with blades at 150 degrees to the handles, designed to give an incision point horizontally offset by approximately 1 centimetre from the posterior vaginal fourchette.

Both versions of the Episcissors‑60 are designed for right‑handed use; there is no left‑handed version available. The device needs cleaning before first use and any reuse, following standard device reprocessing procedures. The device can form part of a reusable equipment birthing pack. There are no accessory tools or materials associated with the Episcissors‑60.

Intended use

The Episcissors‑60 are designed to guide an accurate mediolateral episiotomy at 60 degrees to the perineal midline.

Setting and intended user

The Episcissors‑60 are intended to be used in secondary care midwifery and obstetric units, primary care midwifery units or birth centres, and during home births. The device would be used by midwives or obstetricians trained in the mediolateral episiotomy technique.

Current NHS options

Currently, episiotomies are done using straight or curved episiotomy scissors without any guide for the cutting angle, which therefore must be visually estimated. Left-handed versions of standard episiotomy scissors are also available.

The midwife or obstetrician performing the episiotomy typically judges the mediolateral angle to the midline by eye. Variations in practice between obstetricians and midwives mean that some mediolateral episiotomies are closer to the midline, increasing the risk of obstetric anal sphincter injuries (Tincello et al. 2004). One UK‑based study demonstrated that only 15% of doctors and midwives cut an episiotomy of 58–62 degrees when prompted to specifically cut at 60 degrees (Naidu et al. 2015).

NICE is not aware of other CE‑marked devices that provide a similar guided function to the Episcissors‑60.

Costs and use of the technology

The list price of the Episcissors‑60 is £400 per device, excluding VAT. Current practice is to use normal reusable episiotomy scissors (such as Mayo or Braun‑Stadler types) which range in cost from £10 to £100 each.

The Epscissiors‑60 would not need any special maintenance, servicing or training measures and would require the same reprocessing as normal episiotomy scissors. The lifespan of Episcissors‑60 is expected to be the same as that of standard episiotomy scissors. This would be determined by the level of use, and would be limited by repeated hospital cleaning and sterilisation processes.

Likely place in practice

The Episcissors‑60 would be used as an alternative to standard episiotomy scissors when an episiotomy is indicated, but would otherwise not affect the usual clinical management pathway or service provision.

Specialist commentator comments

One specialist commentator indicated that the angled version of the Episcissors‑60 would be used to ensure the episiotomy incision begins 1 cm away from the fourchette. They highlighted published evidence which showed that episiotomies with an incision point further than 9 mm from the midline are associated with fewer OASIs. Another commentator stated that both versions were user‑friendly and that operator choice determined which was used.

One specialist commentator noted that the incidence of OASIs in women giving birth for the first time in their hospital labour ward had been reduced after standard episiotomy scissors were replaced with Episcissors‑60. This was despite an increase in the overall rate of episiotomies. They highlighted higher levels of confidence among midwives performing episiotomies following the introduction of the Episcissors‑60 and stated that any repair was easier after using the Episcissors‑60 compared with standard episiotomy scissors.

One specialist commentator highlighted that the Episcissors‑60 can only be used by right‑handed practitioners, whereas standard episiotomy scissors can be used by left- or right‑handed people, and can be used to perform a left‑sided episiotomy. They were concerned that if the Episcissors‑60 were not suitable for all practitioners, there may be inequality in access and NHS trusts would be less likely to buy them. They also noted that if different instruments were used for episiotomy then this could make the auditing of perineal trauma more difficult.

One specialist commentator stated that the potential use and benefits of using the Episcissors‑60 are clear, but the evidence base is limited. The large increase in cost would need to be justified in terms of reducing OASIs and a large comparative study with health economics included is needed to demonstrate this. Another specialist commentator noted that the Episcissors‑60's high cost may deter NHS trusts, but that the long‑term investment may lead to fewer OASIs and litigation costs.

Equality considerations

NICE is committed to promoting equality and eliminating unlawful discrimination. We aim to comply fully with all legal obligations to:

  • promote race and disability equality and equality of opportunity between men and women

  • eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief, in the way we produce our guidance (these are protected characteristics under the Equality Act 2010).

The Episcissors‑60 are intended for use in pregnant women during labour. Sex and pregnancy are protected characteristics under the Equality Act (2010).