Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection
Condition: Obstetric Anal Sphincter Injury; Delivery Complication; Obstetric Complication
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The main purpose of the study is to evaluate the effectiveness and safety of the impedance
      spectroscopy device prototype in the detection of anal sphincter injuries in women in the
      early postpartum period. The study is prospective. The study group comprises up to 56
      patients; up to 16 weeks from a natural delivery. The planned participation of each patient
      in the study is up to 4 weeks and two visits will take place at that time.

      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.
    


Intervention name(s): Blood and faeces tests; Impedance spectroscopy test; Full gynecological and proctological examination; Transanal ultrasonography; Anorectal manometry; Determining the degree of sphincter injury
Intervention type(s): Diagnostic Test; Device; Diagnostic Test; Diagnostic Test; Diagnostic Test; Other
Intervention description(s): During V1 - Laboratory tests, particularly for calprotectin concentration assessment; During V1 - the electrical impedance of anal sphincter muscles will be measured; During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy; During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.; During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.; 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obstetric Anal Sphincter Injury; Impedance Spectroscopy