Obstetric Anal Sphincter Injury Clinical Trial
— PROSOfficial title:
Primary Repair of Obstetric Anal Sphincter Injuries (OASIS): a Survey of Emergency Surgeons' Experience
NCT number | NCT05898945 |
Other study ID # | 326703 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 30, 2023 |
Est. completion date | January 1, 2024 |
Verified date | June 2023 |
Source | London North West Healthcare NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 310 |
Est. completion date | January 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | London North West University Hospital NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
London North West Healthcare NHS Trust |
United Kingdom,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Knowledge-related attitudes | Accurate mapping of the pathway of patient follow-up processes following OASI repairs, using a questionnaire | study to be completed over a 12 month period |
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