Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe

Anal sphincter injuries occurring during natural deliveries are often a reason for severe complications, including fecal incontinence. Currently, approximately 80% of these injuries remain unrecognized. Therefore, it is crucial to focus on finding a way to diagnose such injuries as early as possible...

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Main Authors: Marcel Młyńczak, Maciej Rosoł, Antonino Spinelli, Adam Dziki, Edyta Wlaźlak, Grzegorz Surkont, Magda Krzycka, Paulina Pająk, Łukasz Dziki, Michał Mik, Katarzyna Borycka-Kiciak
Format: Article
Language:English
Published: MDPI AG 2021-01-01
Series:Applied Sciences
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Online Access:https://www.mdpi.com/2076-3417/11/2/637
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author Marcel Młyńczak
Maciej Rosoł
Antonino Spinelli
Adam Dziki
Edyta Wlaźlak
Grzegorz Surkont
Magda Krzycka
Paulina Pająk
Łukasz Dziki
Michał Mik
Katarzyna Borycka-Kiciak
author_facet Marcel Młyńczak
Maciej Rosoł
Antonino Spinelli
Adam Dziki
Edyta Wlaźlak
Grzegorz Surkont
Magda Krzycka
Paulina Pająk
Łukasz Dziki
Michał Mik
Katarzyna Borycka-Kiciak
author_sort Marcel Młyńczak
collection DOAJ
description Anal sphincter injuries occurring during natural deliveries are often a reason for severe complications, including fecal incontinence. Currently, approximately 80% of these injuries remain unrecognized. Therefore, it is crucial to focus on finding a way to diagnose such injuries as early as possible to apply the tailored treatment. This study aimed to assess the accuracy of impedance spectroscopy in the diagnostics of obstetric anal sphincter injuries (OASIs) using a specially designed rectal probe called the ONIRY Probe. The protocol of the clinical trials is described at NCT03769792. Twenty women after natural delivery were enrolled in the study and divided into two groups referring to the stage of a perineal tear (Group A: 1- or 2-degrees, and Group B: 3- or 4-degrees of a perineal tear; without or with sphincter injury, respectively). The study design included three visits during which a number of diagnostic tests were performed, including impedance spectroscopy, and 3-dimensional endoanal ultrasound, anorectal manometry, and physical examination as a reference. Statistical analysis comprised raw data analysis, as well as post-processing with the Synthetic Minority Oversampling Technique (SMOTE) method, as the output reference grade was highly imbalanced. A variety of machine learning techniques were applied for the OASI classification (≤2 vs. >2), and Wexner scale (=0 vs. >0). The best efficacies were obtained using Random Forest and k-Nearest Neighbors methods. Best accuracies were 93.3% and 99.6%, for raw and re-analyzed data, respectively, for ultrasound assessed by the OASI classification; and 79.8% and 97.0%, respectively, for clinical evaluation using the Wexner scale. Impedance spectroscopy performed using the ONIRY Probe appears to be a promising diagnostic technique for anal sphincter injury detection but requires further investigation (the next phase of the pilot clinical trial is described at NCT04181840).
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spelling doaj.art-227660f1c690401ba45fd29418c354c02023-12-03T12:46:33ZengMDPI AGApplied Sciences2076-34172021-01-0111263710.3390/app11020637Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY ProbeMarcel Młyńczak0Maciej Rosoł1Antonino Spinelli2Adam Dziki3Edyta Wlaźlak4Grzegorz Surkont5Magda Krzycka6Paulina Pająk7Łukasz Dziki8Michał Mik9Katarzyna Borycka-Kiciak10Faculty of Mechatronics, Institute of Metrology and Biomedical Engineering, Warsaw University of Technology, 02-525 Warsaw, PolandFaculty of Mechatronics, Institute of Metrology and Biomedical Engineering, Warsaw University of Technology, 02-525 Warsaw, PolandHumanitas Clinical and Research Center—IRCCS, 20089 Milan, ItalyDepartment of General and Colorectal Surgery, Medical University of Lodz, 90-647 Lodz, PolandFirst Department of Gynecology and Obstetrics, Clinic for Gynecological Surgery and Oncology, Medical University of Lodz, 94-029 Lodz, PolandFirst Department of Gynecology and Obstetrics, Clinic for Gynecological Surgery and Oncology, Medical University of Lodz, 94-029 Lodz, PolandFirst Department of Gynecology and Obstetrics, Clinic for Gynecological Surgery and Oncology, Medical University of Lodz, 94-029 Lodz, PolandFirst Department of Gynecology and Obstetrics, Clinic for Gynecological Surgery and Oncology, Medical University of Lodz, 94-029 Lodz, PolandDepartment of General and Colorectal Surgery, Medical University of Lodz, 90-647 Lodz, PolandDepartment of General and Colorectal Surgery, Medical University of Lodz, 90-647 Lodz, PolandCentre of Postgraduate Medical Education, Department of Colorectal, General and Oncological Surgery, 01-813 Warsaw, PolandAnal sphincter injuries occurring during natural deliveries are often a reason for severe complications, including fecal incontinence. Currently, approximately 80% of these injuries remain unrecognized. Therefore, it is crucial to focus on finding a way to diagnose such injuries as early as possible to apply the tailored treatment. This study aimed to assess the accuracy of impedance spectroscopy in the diagnostics of obstetric anal sphincter injuries (OASIs) using a specially designed rectal probe called the ONIRY Probe. The protocol of the clinical trials is described at NCT03769792. Twenty women after natural delivery were enrolled in the study and divided into two groups referring to the stage of a perineal tear (Group A: 1- or 2-degrees, and Group B: 3- or 4-degrees of a perineal tear; without or with sphincter injury, respectively). The study design included three visits during which a number of diagnostic tests were performed, including impedance spectroscopy, and 3-dimensional endoanal ultrasound, anorectal manometry, and physical examination as a reference. Statistical analysis comprised raw data analysis, as well as post-processing with the Synthetic Minority Oversampling Technique (SMOTE) method, as the output reference grade was highly imbalanced. A variety of machine learning techniques were applied for the OASI classification (≤2 vs. >2), and Wexner scale (=0 vs. >0). The best efficacies were obtained using Random Forest and k-Nearest Neighbors methods. Best accuracies were 93.3% and 99.6%, for raw and re-analyzed data, respectively, for ultrasound assessed by the OASI classification; and 79.8% and 97.0%, respectively, for clinical evaluation using the Wexner scale. Impedance spectroscopy performed using the ONIRY Probe appears to be a promising diagnostic technique for anal sphincter injury detection but requires further investigation (the next phase of the pilot clinical trial is described at NCT04181840).https://www.mdpi.com/2076-3417/11/2/637obstetric anal sphincter injury (OASI)fecal incontinencenon-invasive diagnosticsnew technologyimpedance spectroscopyONIRY Probe
spellingShingle Marcel Młyńczak
Maciej Rosoł
Antonino Spinelli
Adam Dziki
Edyta Wlaźlak
Grzegorz Surkont
Magda Krzycka
Paulina Pająk
Łukasz Dziki
Michał Mik
Katarzyna Borycka-Kiciak
Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe
Applied Sciences
obstetric anal sphincter injury (OASI)
fecal incontinence
non-invasive diagnostics
new technology
impedance spectroscopy
ONIRY Probe
title Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe
title_full Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe
title_fullStr Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe
title_full_unstemmed Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe
title_short Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe
title_sort obstetric anal sphincter injury detection using impedance spectroscopy with the oniry probe
topic obstetric anal sphincter injury (OASI)
fecal incontinence
non-invasive diagnostics
new technology
impedance spectroscopy
ONIRY Probe
url https://www.mdpi.com/2076-3417/11/2/637
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