Anorectal malformation
Conditions
Interventions
Patients will be underwent electromyography of the anal sphincter muscle using a newly developed pediatric pelvic floor muscle probe for research.
Sponsors
Taketomi Akinobu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be considered (1) Patients who are at least 4 years old but less than 16 years old at the time of consent (2) Patients who do not have a colostomy at the time of consent (3) Persons who have received a full explanation of their participation in this study, and who have obtained the free and voluntary written consent of their surrogate after full understanding.
Exclusion criteria
Exclusion criteria: Patients who with any one of the following conditions will be excluded from the study. (1) Patients who are unable to cooperation in anorectal examinations (2) Patients who are unable to undergo rectal examination due to anal stenosis (3) Patients with mental reterdation (4) Patients with an implanted defibrillator or pacemaker (5) Patients with a history of hypersensitivity to pelvic floor muscle probe materials or lubricants (6) Other patients determined to be inappropriate as research patients by the principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the mean value of the myogenic potential of the anal sphincter at rest and the mean value of the myogenic potential of the anal sphincter during voluntary contraction | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Correlation between the difference in myogenic potential of the anal sphincter at rest and during voluntary contraction and the difference in anal manometry (2) Correlation between myogenic potential of the anal sphincter and anal manometry at rest (3) Correlation between myogenic potential of the anal sphincter and anal manometry during voluntary contraction (4) Sensitivity, specificity and AUC value of anal sphincter electromyography (5) Relationship between anal sphincter electromyography and anal manometry and defecatory function score (6) Relationship between anal sphincter electromyography and anal pressure test and defecatory function score (7) Exploratory analysis to establish an evaluation method of anal function using anal pressure test values. *The analysis items required for the development of the medical device shall be added sequentially. Safety Outcome(s) (1) Pain assessment associated with anal sphincter electromyography (Pain Rating Scale) (2) Detalis and rate of adverse events of sphincter electromyography | — |
Contacts
Public ContactMomoko Ara
Hokkaido University Hospital
Outcome results
None listed