Evidence review

Clinical and technical evidence

Regulatory bodies

A search of the Medicines and Healthcare Products Regulatory Agency website revealed no manufacturer Field Safety Notices or Medical Device Alerts for this device. No reports of adverse events were identified from a search of the US Food and Drug Administration database: Manufacturer and User Device Facility Experience (MAUDE).

Clinical evidence

Three relevant studies were selected for review. One study by Sawant and Kumar (2015) compared the post‑delivery suture angle achieved using the Episcissors‑60 with that achieved using Braun‑Stadler scissors. A further 2 case series (Patel and Ubale 2014, Freeman et al. 2014) investigated the use of Episcissors‑60 and the post‑delivery suture angle.

The comparative trial was done in a single labour ward in a hospital in India. It compared the post‑delivery suture angles achieved with the Braun‑Stadler episiotomy scissors and the angled Episcissors‑60. Two groups of clinicians worked in alternate 24‑hour cycles, with 1 group using the Episcissors‑60 and the other using Braun‑Stadler scissors. The study included 63 women giving birth for the first time. The episiotomies were given for clinical indications such as prolonged second stage of labour, foetal distress and instrumental delivery. Episiotomies were done by doctors and post‑delivery suture angles were measured at an unspecified time after birth. Length of cut and distance from the caudal (lower) end of the cut to the anus were also measured. The average post‑delivery suture angle achieved with the Episcissors‑60 was 40.2 degrees, compared to an average post‑delivery suture angle of 28.3 degrees with the Braun‑Stadler scissors. The distance from the caudal end of the cut to the anus was 15 mm greater with the Episcissors‑60 than with the Braun‑Stadler scissors. Episiotomies done with the Episcissors‑60 were also 7 mm longer than those done with the Braun‑Stadler scissors. The authors concluded that, compared with Braun‑Stadler scissors, the Episcissors‑60 cut episiotomies that were angled further away from the midline and were further from the anus, and therefore had a lower risk of OASIs. A summary of the study is reported in table 1.

Table 1 Summary of the Sawant and Kumar (2015) comparative trial

Study component

Description

Objectives/hypotheses

To compare episiotomy suture angles with Braun‑Stadler episiotomy scissors with the fixed angled Episcissors‑60.

Study design

Comparative trial

Setting

Labour ward in a hospital in India

Inclusion/exclusion criteria

Inclusion criteria: women with indications for episiotomies, such as prolonged second stage of labour, instrumental vaginal delivery, foetal distress

Primary outcomes

Post‑delivery suture angle

Post‑delivery distance from midline

Length of episiotomy

Cases of OASIs

Statistical methods

Two‑tailed t‑tests were used to compare the independent groups.

Participants

n=63 (Episcissors‑60 group n=31, Braun‑Stadler group n=32)

Results

Post‑delivery suture angle

Episcissors‑60: 40.6 degrees, 95% CI ± 2, IQR 35–45

Braun‑Stadler: 28.3 degrees, 95% CI ± 2, IQR 25–30

P<0.0001

Post‑delivery distance from midline

Episcissors‑60: 35 mm, 95% CI ± 2.2, IQR 30–39

Braun‑Stadler: 19.5 mm, 95% CI ± 1.3, IQR 14.75–22.25

P<0.0001

Length of episiotomy

Episcissors‑60: 47 mm

Braun‑Stadler: 40 mm

P<0.0001

Cases of OASIs

Episcissors‑60: 0

Braun‑Stadler: 1

Conclusions

The sutured episiotomies achieved with the Episcissors‑60 were angled further away from the midline and ended further from the anus and would therefore lower the risk of OASIs.

Abbreviations: CI, confidence interval; IQR, interquartile range; mm, millimetres; n, number of patients; OASIs, obstetric anal sphincter injury.

The study by Patel and Ubale (2014) was done in 2 private maternity hospitals in India and included 25 women for whom episiotomy was clinically indicated (by foetal distress, prolonged second stage of labour or maternal exhaustion). Women who were indicated for instrumental delivery were excluded from the study. Episiotomies were done by 2 experienced obstetricians using the angled version of Episcissors‑60. Twenty four women had cephalic deliveries (head first) and 1 woman had a vaginal breech delivery (buttocks or feet first). Before suturing, per rectal examinations were done to detect any OASIs. The median post‑delivery suture angle was measured as 50 degrees and no OASIs were detected. A summary of the case series is reported in table 2.

Table 2 Summary of the Patel and Ubale (2014) case series

Study component

Description

Objectives/hypotheses

To test the efficacy of the Episcissors‑60 in spontaneous vaginal deliveries

Study design

Case series

Setting

Two private maternity hospitals in Thane, India

Inclusion/exclusion criteria

Inclusion criteria: women with clinical indications for episiotomy, including foetal distress, prolonged second stage of labour and maternal exhaustion

Exclusion criteria: women requiring an instrumental delivery

Primary outcomes

Post‑delivery suture angle

Cases of obstetric anal sphincter injury

Statistical methods

None reported

Participants

n=25 women (16 women were nulliparous, 8 women were para 1 and 1 woman was para 2)

Results

One woman had a breech delivery, and the remaining 24 women had cephalic deliveries

Post‑delivery suture angle

Median post‑delivery suture angle of the episiotomy: 50 degrees (SD 3.5 degrees, IQR 48–54 degrees, range 45–55 degrees)

Cases of obstetric anal sphincter injury

No cases were detected in this series.

Conclusions

The authors concluded that the angled‑version Episcissors‑60 demonstrated a post‑delivery suture angle of 50 degrees in a cohort of Indian women having spontaneous vaginal deliveries.

Abbreviations: CI, confidence interval; n, number of patients; SD, standard deviation; IQR, interquartile range.

A UK‑based study by Freeman et al. (2014) tested a prototype of the straight‑version of Episcissors‑60. The prototype was used by experienced obstetric specialty registrars, firstly on models of vaginas and then on 17 women having instrumental vaginal delivery in a delivery suite. The subjects were asked to record the sutured angle of the episiotomy. The traced episiotomy angles were given to an investigator who was blinded to all patient details, and who then measured the angle of the episiotomy. The obstetric trainees were also asked to complete a short ease‑of‑use assessment for the instrument.

The median post‑delivery suture angle was 43 degrees (95% confidence interval 38.8 to 46.0). One patient had a grade 3a OASI with a post‑delivery suture angle of 30 degrees. The authors highlighted that this patient had a failed ventouse (vacuum) delivery which was converted to a forceps delivery. The results of the ease‑of‑use assessment revealed that 88% of the obstetric trainees agreed or strongly agreed that the Episcissors‑60 were easy to use. However, 1 trainee strongly disagreed because they were left‑handed and unable to orientate themselves to properly align the instrument. The results of this study were used to guide design iterations of the device, such as making the guide‑limb flexible to accommodate the baby's head at crowning and increasing the length of the blades.

The authors concluded that the Episcissors‑60 consistently delivered a post‑delivery suture angle of 43 degrees, offering an alternative to estimating episiotomy angles by eye and a potential preventative strategy to reduce obstetric anal sphincter injuries. A summary of the case series is reported in table 3.

Table 3 Summary of the Freeman et al. (2014) case series

Study component

Description

Objectives/hypotheses

To establish whether an episiotomy performed at an angle of 60 degrees using an Episcissors‑60 prototype could produce a post‑delivery suture angle of 45 degrees

Study design

Case series

Setting

The study was performed in the delivery suite of a hospital. The evaluation ran from October 2011 to February 2012.

The prototype was initially tested on models of vaginas and then in women giving birth.

Inclusion/exclusion criteria

Inclusion criteria: women having an instrumental vaginal delivery (ventouse or forceps).

Primary outcomes

Post‑delivery suture angle

Ease of use of the instrument

Statistical methods

None reported

Participants

n=17 women having instrumental deliveries (14 ventouse, 2 low forceps, 1 sequential ventouse‑forceps)

Results

Post‑delivery suture angle

Mean post‑delivery suture angle: 42.4±7 (30–60) degrees

Median post‑delivery suture angle: 43 degrees (95% CI 38.8 to 46)

Ease of use of the instrument

Trainees rated the ease of use of the instrument on a 5 point scale:

  • 'Strongly agree': 10 cases

  • 'Tend to agree': 5 cases

  • 'Neither agree or disagree': 1 case

  • 'Tend to disagree': 0 cases

  • 'Strongly disagree': 1 case

The 'strongly disagree' case was due to the trainee being left‑handed and unable to orientate herself in order to align the Episcissors‑60. The comments relating to 'tend to agree' were regarding the length of the cut, where trainees did not feel it was of a sufficient length.

One patient suffered a grade 3a obstetric anal sphincter injury (episiotomy scar angle of 30 degrees).

Conclusions

The Episcissors‑60 consistently delivered a post‑delivery suture angle of 43 degrees, offering an alternative to estimating episiotomy angles by eye and a potential preventative strategy to reduce obstetric anal sphincter injuries.

Abbreviations: CI, confidence interval; n, number of patients.

Recent and ongoing studies

Medinvent, the UK supplier, identified several case series being presented as conference abstracts during 2015 but no information is publicly available.

No other ongoing or in‑development trials on the Episcissors‑60 for guided mediolateral episiotomy were identified from searches of clinical trial registers.

Costs and resource consequences

In 2011–12, 15.2% of all births in England (101,678) needed an episiotomy (HESonline 2012). Current practice is to use normal episiotomy scissors (such as Mayo or Braun‑Stadler types) which range in cost from £10 to £100 each. The Episcissors‑60 would replace standard episiotomy scissors; at a cost of £400, they would therefore represent an initial additional cost to the NHS. This cost could potentially be offset by fewer OASIs and the resulting savings. The NICE costing report produced for its guideline on faecal incontinence estimates the initial cost of OASI repair as £1289 per person, excluding imaging and outpatient follow‑up.

No published evidence on the total resource consequences of the Episcissors‑60 was identified.

Strengths and limitations of the evidence

The evidence base for the Episcissors‑60 is currently limited to 1 small comparative study and 2 non‑comparative case series.

The comparative study by Sawant and Kumar (2015) showed that compared with Braun‑Stadler scissors, the Episcissors‑60 produced a post‑delivery suture angle that was further from the perineal midline by almost 12 degrees. However, the study was not sufficiently powered to detect differences in OASIs so any beneficial changes in this outcome were inferred rather than measured. The authors claimed that the study was 'similar to a prospective cluster randomised trial'; but because only 2 groups of clinicians took part in the trial, with 1 group using the Episcissors‑60 and the other using the Braun‑Stadler comparator, there was no randomisation. The title of the paper is therefore rather misleading, given this study design. The clinician who did the episiotomy also measured the post‑delivery suture angle, which creates potential assessment bias. However, the inclusion criteria were consistent with UK national guidelines for episiotomy and may be generalisable to current UK practice.

Neither of the case series (Patel and Ubale 2014, Freeman et al. 2014) compared the use of Episcissors‑60 with standard practice and so could not report on changes in episiotomy angles. As both studies were relatively small, important clinical outcomes such as the rate of OASIs could not be accurately measured.

The case series by Patel and Ubale (2014) was done in India and included women clinically indicated for episiotomies. However, it excluded women having instrumental delivery, which limits the generalisability of the study to current NHS practice. The clinician who did the episiotomy also measured the post‑delivery suture angle, which creates potential assessment bias.

The main limitation of the evaluation by Freeman et al. (2014) is that the obstetric trainees were using a prototype of the Episcissors‑60 (this prototype formed the basis of the current straight Mayo version of the Episcissors‑60). The study took place in an English hospital and so indications for episiotomy were consistent with UK national guidelines. The investigator was blinded to the patient and trainee operator, which lowers the risk of assessment bias. The authors reported a single case of a grade 3a OASI related to a 30‑degree post‑delivery suture angle following a failed ventouse delivery which was converted to a forceps delivery. However, it was not stated if this injury was attributable to the use of the Episcissors‑60 or could otherwise have been prevented. The study does not report how OASIs were detected, or the number of obstetric trainees who did the episiotomies and were included in the ease of use assessment.