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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum.
The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.
Patients enrolled in study will be investigated by both types of anorectal catheters, first by anorectal high resolution flexible, thinner, solid-state catheter and after that with rigid, thicker, solid-state catheter. Both procedures will be undertaken during one session. There will be used standard protocol of the procedure that measures conventional manometric parameters (resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and recto anal inhibitory reflex threshold.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High resolution anorectal manometry | Other | All subjects will be investigated by high-resolution anorectal manometry. At the beginning the anorectal cather will be used to record conventional parameters and after that 3D high-definition anorectal manometric catheter will be inserted in order to measure conventional parameters and 3D picture of anorectum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-resolution anorectal manometry | Device | Recording of conventional manometric parameters after insertion of the catheters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Resting pressure of the anorectal area | Resting pressure will be measured after insertion catheter into anorectum. The software automatically record pressure while patient is lying on the bed. The parameter is recorded with 2 different types of anorectal catheters and the difference is evaluated. | 20 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum squeeze pressure | Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times). | 1 min |
| Bear down manoeuver | Pressures are recorded after the patient is asked to bear down for 20 s (repeated 2 times) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcin Banasiuk, PhD | Contact | +48223179463 | mbanasiu@tlen.pl |
| Name | Affiliation | Role |
|---|---|---|
| Marcin Banasiuk, PhD | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric Gastroenterology and Nutrition | Recruiting | Warsaw | 02-091 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34515101 | Derived | Banasiuk M, Dobrowolska ME, Skowronska B, Konys J, Banaszkiewicz A. Comparison of Anorectal Function as Measured with High-Resolution and High-Definition Anorectal Manometry. Dig Dis. 2022;40(4):448-457. doi: 10.1159/000518357. Epub 2021 Aug 10. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
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| 1 min |
| Thresholds of sensation | The balloon at the top of the catheter is being filled with air until a patient is able to report sensation, urge and discomfort. | 1 min |
| Recto anal inhibitory reflex | The balloon at the top of the catheter is being filled with air until the relaxation of anal sphincter is observed. | 5 min |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |