External Phase MRI in Diagnosis of OASI

NCT03039374 | Completed

• 1 other identifier: ISR-2014-10458
• Study Type: observational
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anal Sphincter Injury; Obstetrics Trauma

Keywords

OASI; Faecal incontinence; Obstetric anal sphincter injury; MRI

Outcome Measures

Primary Outcomes (1)

• Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury

  Comparison of anal sphincter characteristics (length, thickness at 3 and 9 o'clock) and placement of the possible rupture with both imaging modalities

  6 months to 1 year

Study Arms (1)

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.

Other: Magnetic resonance imaging

Interventions

Magnetic resonance imaging OTHER

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

OASI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients older than 18 and a 3rd or 4th degree perineal tear observed 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.

You may qualify if:

• Women with OASI

You may not qualify if:

• Under 18

Sponsors & Collaborators

• University of Turku: lead
• Medtronic: collaborator

MeSH Terms

Conditions

Encopresis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Mikael Victorzon, prof.

  Professor of surgery Turku University

  STUDY DIRECTOR

• Jaan Kirss, MD

  Resident in Gastroenterological surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: February 1, 2017
• Study Start: September 1, 2014
• Primary Completion: September 20, 2017
• Study Completion: October 27, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share