Normal Values in Ano-rectal 3D High Resolution Manometry

Not Applicable

Completed

• Conditions: Constipation; Fecal Incontinence; Anorectal Disorder
• Interventions: Procedure: Anorectal 3D-high resolution manometry; Procedure: Anorectal radial endosonography (rotative 360° probe); Procedure: Dynamic anorectal endosonography (sagittal and radial)

• Registration Number: NCT01710579
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Ano-rectal manometry is indicative in patients with either fecal incontinence or constipation. Recently anorectal 3D- high resolution manometry has been developed. Pressure variations are measured circumferentially along the anal canal. It may allow a better understanding of anorectal disorders by displaying anal pressure asymmetry and it could be useful to assess the functional anatomy of the pelvic floor better than conventional manometry.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-10-17
• Study First Posted: 2012-10-19
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM 1 Healthy Volunteers	Anorectal 3D-high resolution manometry	Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
ARM 3 Patients with constipation	Anorectal radial endosonography (rotative 360° probe)	Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
ARM 1 Healthy Volunteers	Anorectal radial endosonography (rotative 360° probe)	Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
ARM 1 Healthy Volunteers	Dynamic anorectal endosonography (sagittal and radial)	Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
ARM 2: Patients with fecal incontinence	Anorectal 3D-high resolution manometry	Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
ARM 2: Patients with fecal incontinence	Anorectal radial endosonography (rotative 360° probe)	Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
ARM 3 Patients with constipation	Anorectal 3D-high resolution manometry	Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
ARM 2: Patients with fecal incontinence	Dynamic anorectal endosonography (sagittal and radial)	Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
ARM 3 Patients with constipation	Dynamic anorectal endosonography (sagittal and radial)	Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography

Primary Outcome Measures

Name	Time	Method
Anal pressure pattern at rest, during voluntary maximal squeezing and bear down Anal pressure pattern at rest, during voluntary maximal squeezing and bear down	during procedure	Following parameters will be measured at the level of anal sphincter: * Minimal pressure (amplitude and location); * Maximal pressure (amplitude and location); * Mean pressure; * Asymmetry

Secondary Outcome Measures

Name	Time	Method
presence of ano-rectal reflex.	during procedure
Ano-rectal radial endosonography	During procedure	Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest
Dynamic ano-rectal endoconography	During procedure	presence of pelvic floor disorder (rectocele, enterocele)

Trial Locations

Locations (1)

Unité d'Exploration Fonctionnelle Digestive Hôpital Edouard Herriot; 🇫🇷 Lyon, France