Primary Repair of Obstetric Anal Sphincter Injuries (OASIS) by Surgeons (PROS Study)

NCT05898945 | Completed DMC

• 1 other identifier: 326703
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Anal Sphincter Injury

Keywords

primary repair; management; emergency surgeons; incontinence; outcomes; survey; coloproctologists

Outcome Measures

Primary Outcomes (2)

• Use of Knowledge

  Ascertainment of the knowledge of trainee, SAS and consultant (varying in age, sub-speciality and region) knowledge and skills in primary OASI repairs, in guideline and policy-related documents and adherence to management recommendations, using a questionnaire

  study to be completed over a 12 month period

• Training and confidence

  Effect of the number of OASI repairs performed throughout the career of trainees, SAS and consultants (varying in age, sub-speciality and region) and training received, on confidence in performing OASI repairs, using a questionnaire

  study to be completed over a 12 month period

Secondary Outcomes (1)

• Knowledge-related attitudes

  study to be completed over a 12 month period

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Senior House Officers or Foundation Doctors
• Doctors who do not cover an emergency rota
• Doctors working abroad

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

London North West University Hospital NHS Trust

London, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 23834484 BACKGROUND

• 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.

  PMID: 20199348 BACKGROUND

• 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.

  PMID: 6147604 BACKGROUND

• 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.

  PMID: 27643513 BACKGROUND

• 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.

  PMID: 16411998 BACKGROUND

• 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.

  PMID: 18385917 BACKGROUND

• 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.

  PMID: 16855993 BACKGROUND

• 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.

  PMID: 12006105 BACKGROUND

• 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.

  PMID: 8173367 BACKGROUND

• 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.

  PMID: 18059077 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: June 12, 2023
• Study Start: April 30, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: April 4, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)