Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection
NCT ID: NCT04181840
Last Updated: 2020-09-16
Study Results
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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COMPLETED
NA
49 participants
INTERVENTIONAL
2019-10-15
2020-07-20
Brief Summary
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After obtaining written consent, at the first visit (V1) each patient will undergo a physical examination (both proctological and gynecological examination), blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected. The presence of clinical symptoms of both gas and stool incontinence will be assessed during the visit with the use of Wexner's scale. Then, the dates of two reference tests will be planned: Trans-rectal USG and Recto-anal manometry which will be performed as part of the V1 visit within a period not exceeding 27 days.
The V2 visit, which will also be the final visit, will include a reassessment of the patient's general condition, recording the values of basic vital parameters, subjective and physical examination, and then the doctor conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.
During the visits, all adverse events will also be monitored, both those reported by patients and those related to the examined diagnostic device.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Impedance spectroscopy
Maximum 56 women up to 16 weeks from a natural delivery, with at least one perinatal anal sphincter injury risk factor, such as: the extended second delivery phase, instrumental delivery (vacuum or forceps), shoulder dystocia, birth weight of the child \> 4kg, episiotomy, uncontrolled perineal laceration (in patients with crotch protection).
The planned interventions are:
* Blood and faeces tests
* Impedance spectroscopy test
* Full gynecological and proctological examination
* Transanal ultrasonography
* Anorectal manometry
Blood and faeces tests
During V1 - Laboratory tests, particularly for calprotectin concentration assessment
Impedance spectroscopy test
During V1 - the electrical impedance of anal sphincter muscles will be measured
Full gynecological and proctological examination
During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy
Transanal ultrasonography
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Anorectal manometry
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Determining the degree of sphincter injury
During V2 - conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.
Interventions
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Blood and faeces tests
During V1 - Laboratory tests, particularly for calprotectin concentration assessment
Impedance spectroscopy test
During V1 - the electrical impedance of anal sphincter muscles will be measured
Full gynecological and proctological examination
During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy
Transanal ultrasonography
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Anorectal manometry
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Determining the degree of sphincter injury
During V2 - conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.
Eligibility Criteria
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Inclusion Criteria
* 18-49 years old,
* up to 16 weeks from a natural delivery
* with the presence of:
1. clinically confirmed OASIS at least stage II, as a result of an episiotomy or uncontrolled crotch rupture (in patients with crotch protection), or
2. at least one risk factor, such as:
* the extended second delivery phase,
* instrumental delivery (vacuum or forceps),
* shoulder dystocia,
* birth weight of the child \> 4kg,
* episiotomy,
* uncontrolled perineal laceration (in patients with crotch protection),
* induction of delivery using oxytocin,
* head circumference ≥34 mm and other.
* the patient's understanding of the nature of the clinical study and permission in writing from the patient to participate in this study.
Exclusion Criteria
* the presence of chronic diseases not treated or treated insufficiently (e.g., incorrectly controlled hypertension),
* the presence of diseases with accompanying symptoms of fecal incontinence history of proctology surgery's whit postoperative complication,
* the presence of inflammatory bowel diseases during the exacerbation phase,
* the treatment in the last year because of serious, progressive, uncontrolled cardiological, pulmonary, nephrology, contagious or psychiatric illness whose course could affect the patient's risk increase due to participation in the study,
* significant disease symptoms so far undiagnosed,
* the presence or suspected malignant disease or previous on previous oncological treatment in the last 5 years,
* the presence of a cardiac stimulator or cardioverter-defibrillator,
* severe surgery or severe trauma in the last year.
18 Years
49 Years
FEMALE
No
Sponsors
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OASIS Diagnostics S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Małgorzata Uchman-Musielak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Specialist Medical Practice
Locations
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Praktyka Lekarska Małgorzata Uchman-Musielak
Warsaw, Masovian Voivodeship, Poland
Countries
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Related Links
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Sponsor's website
Other Identifiers
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2/1/2019 (May 6)
Identifier Type: -
Identifier Source: org_study_id
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