Clinical trial NCT05898945: Primary Repair of Obstetric Anal Sphincter Injuries (OASIS) by Surgeons (PROS Study)
Official title: Primary Repair of Obstetric Anal Sphincter Injuries (OASIS): a Survey of Emergency Surgeons' Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Anal Sphincter Injury
Keywords: primary repair
management
emergency surgeons
incontinence
outcomes
survey
coloproctologists
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 310
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency general surgeons (registrar or consultant level) are eligible to participate. This includes registrar trainees (StR), staff grades, associate specialists, speciality doctors and consultants who are on the speciality register. They will need to be participating in an emergency on-call rota and working in Great Britain and Ireland.

Brief summary: Third- or fourth-degree perineal tears, collectively known as Obstetric Anal Sphincter Injuries or OASIS, may occur following a vaginal birth. OASIS may have catastrophic consequences, including anal incontinence. Satisfactory primary repair of OASIS is prudent in reducing the risk of maternal morbidity. Although Obstetricians are typically involved in the acute repair of OASIS, General Surgeons may be called to assist in cases of severe anatomical disruption.

The investigators have constructed a survey to explore the experience and current practice of Emergency Surgeons in relation to the repair of OASIS. The investigators will gather information including their level of exposure, understanding of current guidelines and confidence in performing these repairs. This will help the investigators identify if further training is required and will enable them to put forward recommendations for future practice. The findings will be presented at conferences and meetings and published in journals.

Detailed description: To date, there is little consensus on who should perform the primary repair of obstetric anal sphincter injuries (OASIS), with the Royal College of Obstetricians and Gynaecologists (RCOG) stating that the repair should be undertaken by a trained practitioner and that 'involvement of a colorectal surgeon will be dependent on local protocols, expertise and availability'.

In cases of severe anatomical disruption, the on-call general surgeon may be summoned upon to assist with the repair. They may not be a colorectal surgeon, and if they are, they may not specialise in pelvic floor surgery. A previous survey of practice amongst UK obstetricians and coloproctologists identified a wide variation in experience, methods of repair, follow up and recommendations for future delivery.

The aim of this study is to explore emergency surgeons' knowledge in relation to the acute repair of OASIS and to compare this with current recommendations and best practice guidance. This, in turn, will help identify if further training is required.

Satisfactory repair of acute OASIS is necessary for the following reasons:

* It may reduce the risk of anal incontinence, a stigmatising condition which may have substantial impact on an individual's quality of life and day-to-day living.
* By reducing the incidence of OASIS-related anal incontinence, the financial burden associated with the management of this condition as well as the risk of litigation will also be reduced

Eligibility criteria: Inclusion Criteria:

* Registrar or above
* Cover an Emergency on-call rota for General Surgery
* Working in Great Britain and Ireland

Exclusion Criteria:

* • Senior House Officers or Foundation Doctors

  * Doctors who do not cover an emergency rota
  * Doctors working abroad

Primary outcomes:
measure: Use of Knowledge
timeFrame: study to be completed over a 12 month period
measure: Training and confidence
timeFrame: study to be completed over a 12 month period
Secondary outcomes:
measure: Knowledge-related attitudes
timeFrame: study to be completed over a 12 month period
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London North West University Hospital NHS Trust
Study officials:
References:
citation: Gurol-Urganci I, Cromwell DA, Edozien LC, Mahmood TA, Adams EJ, Richmond DH, Templeton A, van der Meulen JH. Third- and fourth-degree perineal tears among primiparous women in England between 2000 and 2012: time trends and risk factors. BJOG. 2013 Nov;120(12):1516-25. doi: 10.1111/1471-0528.12363. Epub 2013 Jul 3.
citation: Bols EM, Hendriks EJ, Berghmans BC, Baeten CG, Nijhuis JG, de Bie RA. A systematic review of etiological factors for postpartum fecal incontinence. Acta Obstet Gynecol Scand. 2010 Mar;89(3):302-14. doi: 10.3109/00016340903576004.
citation: Snooks SJ, Setchell M, Swash M, Henry MM. Injury to innervation of pelvic floor sphincter musculature in childbirth. Lancet. 1984 Sep 8;2(8402):546-50. doi: 10.1016/s0140-6736(84)90766-9.
citation: Sioutis D, Thakar R, Sultan AH. Overdiagnosis and rising rate of obstetric anal sphincter injuries (OASIS): time for reappraisal. Ultrasound Obstet Gynecol. 2017 Nov;50(5):642-647. doi: 10.1002/uog.17306.
citation: Andrews V, Sultan AH, Thakar R, Jones PW. Occult anal sphincter injuries--myth or reality? BJOG. 2006 Feb;113(2):195-200. doi: 10.1111/j.1471-0528.2006.00799.x.
citation: Abramov Y, Feiner B, Rosen T, Bardichev M, Gutterman E, Lissak A, Auslander R. Primary repair of advanced obstetric anal sphincter tears: should it be performed by the overlapping sphincteroplasty technique? Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1071-4. doi: 10.1007/s00192-008-0592-0. Epub 2008 Apr 3.
citation: Fernando R, Sultan AH, Kettle C, Thakar R, Radley S. Methods of repair for obstetric anal sphincter injury. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD002866. doi: 10.1002/14651858.CD002866.pub2.
citation: Fernando RJ, Sultan AH, Radley S, Jones PW, Johanson RB. Management of obstetric anal sphincter injury: a systematic review & national practice survey. BMC Health Serv Res. 2002 May 13;2(1):9. doi: 10.1186/1472-6963-2-9.
citation: Sultan AH, Kamm MA, Hudson CN, Bartram CI. Third degree obstetric anal sphincter tears: risk factors and outcome of primary repair. BMJ. 1994 Apr 2;308(6933):887-91. doi: 10.1136/bmj.308.6933.887.
citation: Norderval S, Markskog A, Rossaak K, Vonen B. Correlation between anal sphincter defects and anal incontinence following obstetric sphincter tears: assessment using scoring systems for sonographic classification of defects. Ultrasound Obstet Gynecol. 2008 Jan;31(1):78-84. doi: 10.1002/uog.5155.