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External Phase MRI in Diagnosis of OASI

NCT ID: NCT03039374

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-10-27

Brief Summary

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There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter lesion after birth can be challenging the total amount of women having obtained a sphincter lesion could be even grater.

The aim of our study is to compare different tools in the diagnosis of obstetric anal sphincter injury. In doing so the investigators hope to achieve early diagnosis of this pathology and thus facilitate early treatment of a possible sphincter defect.

Detailed Description

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See the attacher research plan for a more detailed description

Conditions

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Anal Sphincter Injury Obstetrics Trauma

Keywords

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OASI Faecal incontinence Obstetric anal sphincter injury MRI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OASI patients

All patients older than 18 and a 3rd or 4th degree perineal tear during birth meet the inclusion criteria. All women who have obtained such a injury during birth in the Vaasa or Seinäjoki Central hospitals will be evaluated for eligibility.

Magnetic resonance imaging

Intervention Type OTHER

The extent of obstetric anal sphincter injury will be evaluated using MRI, endoanal ultrasound and anal manometry

Interventions

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Magnetic resonance imaging

The extent of obstetric anal sphincter injury will be evaluated using MRI, endoanal ultrasound and anal manometry

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Women with OASI

Exclusion Criteria

Under 18
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Jaan Kirss

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mikael Victorzon, prof.

Role: STUDY_DIRECTOR

Professor of surgery Turku University

Jaan Kirss, MD

Role: PRINCIPAL_INVESTIGATOR

Resident in Gastroenterological surgery

Other Identifiers

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ISR-2014-10458

Identifier Type: -

Identifier Source: org_study_id