Clinical Trial

CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence

Study acronym: CArE for OAsI
Recruiting
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Record status
This record was last updated May 25, 2025 (before its estimated July 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be safeguarded by the presence of robust care pathways that ensure adequate follow up and care provision. As obstetric anal sphincter injuries have been associated with increased litigation rates over the years, positive interventions towards patient care will help ameliorate the financial burden that litigation carries on the National Health Service. It is noteworthy of mention that perineal injury, in itself, may not be suggestive of negligent care and is a recognized complication of vaginal delivery. However, a failure to adequately manage the injury may carry medicolegal implications.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-11-20; most recent amendment 2025-05-21.
Status change: Not Yet Recruiting → Recruiting 2024-04-03
Trial Details
NCT Number NCT06143072
Lead Sponsor London North West Healthcare NHS Trust
Conditions Obstetric Anal Sphincter Injury, Severe Perineal Trauma, Grade 3 Perineal Tear, Grade 4 Perineal Tear, Anal Incontinence, Faecal Incontinence, Urgency, Deferral Time +6 more
Enrollment 112 participants
Start Date 2024-01-01
Primary Completion 2025-07-01 (estimated)
Study Completion 2025-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-25