Medical Devices: Evidence and Research (Feb 2014)
Cutting a mediolateral episiotomy at the correct angle: evaluation of a new device, the Episcissors-60
Abstract
RM Freeman,1,2 HJ Hollands,1 LF Barron,3 DS Kapoor41Directorate of Obstetrics and Gynaecology, Plymouth Hospitals NHS Trust, Derriford Hospital, 2Plymouth University Peninsula Schools of Medicine and Dentistry, 3Directorate of Healthcare Science and Technology at Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth, 4Urogynaecology Unit, Royal Bournemouth Hospital, Bournemouth, UKBackground: Anal incontinence is nine times more prevalent in women than in men due to obstetric anal sphincter injury (OASI). OASI is linked to midline episiotomies and mediolateral episiotomies with post-delivery angles of <30 and >60 degrees. Studies show that doctors and midwives are unable to correctly "eyeball" the safe angle required due to perineal stretching by the fetal head at crowning. A new scissor instrument (Episcissors-60) was devised to allow cutting a mediolateral episiotomy at a fixed angle of 60 degrees from the perineal midline.Methods: Scissors with a marker guide limb pointing towards the anus were devised, ensuring an angle of 60 degrees between the scissor blades and the guide limb. This device was initially tested in models. Post-delivery angles were recorded on transparencies and analyzed by an author blinded to clinical details. Accoucheurs were asked to rate the ease of use on a 5-point scale.Results: Of the 17 women, 14 delivered with ventouse, two with forceps, and one with sequential ventouse–forceps. Indications for instrumental delivery were suboptimal cardiotocogram and/or prolonged second stage of labor. Mean birth weight was 3.41 (2.92–4.12) kg. A mean post-delivery angle of 42.4±7 (range 30–60, median 43) degrees (95% confidence interval 38.8–46) was achieved with the Episcissors-60 instrument. Eighty-eight percent of clinicians agreed or strongly agreed that the scissors were easy to use.Conclusion: The Episcissors-60 delivered a consistent post-delivery angle of 43 degrees. They could replace "eyeballing" when performing mediolateral episiotomies and form part of a preventative strategy to reduce OASI.Keywords: 60 degree episiotomy, anal incontinence, episiotomy scissors, mediolateral episiotomy, obstetric anal sphincter injury, OASI