Ano-rectal 3D High Resolution Manometry: Normal Values and Comparison With Ultrasound Examination in Healthy Volunteers, Patients With Fecal Incontinence and Patients With Constipation

Hospices Civils de Lyon1 site in 1 country127 target enrollmentStarted: September 1, 2012Last updated: May 28, 2019

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Hospices Civils de Lyon
Enrollment: 127
Locations: 1
Primary Endpoint: Anal pressure pattern at rest, during voluntary maximal squeezing and bear down Anal pressure pattern at rest, during voluntary maximal squeezing and bear down

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Parallel
Primary Purpose: Diagnostic
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Subject older than 18 years Absence of anorectal symptoms (no constipation, no fecal incontinence) Absence of pelvic floor disorders Vaizey score = 0 Kess score < 9 Subject with health insurance Written informed consent Non inclusion criteria: Patient younger than 18 years Pregnancy Incapability to give consent No written informed consent Participation to another study at the same time Previous ano-rectal surgery Pelvic radiotherapy Neurological disorder Diabetes mellitus
•Arm 2: 50 patients with fecal incontinence
•Inclusion criteria:
•Subject older than 18 years Patient referred for anorectal manometry and/or ultrasound examination Fecal incontinence as main complain Vaizey score > 6 Kess score < 9 Subject with health insurance Written informed consent
•Non inclusion criteria:
•Patient younger than 18 years Pregnancy Incapability to give consent No written informed consent Participation to another study at the same time Rectal tumor Rectal stenosis Ileo-anal or ileo-rectal anastomosis Anal fissure Anal fistula Arm 3: 50 patients with constipation
•Inclusion criteria:
•Subject older than 18 years Patient referred for anorectal manometry and/or ultrasound examination Constipation as main complain Feeling of incomplete evacuation and/or manual disimpaction defined as needing to press in or around the anus to aid defecation Vaizey score < 6 Kess score < 9 Subject with health insurance Written informed consent
•Non inclusion criteria:
•Patient younger than 18 years Pregnancy Incapability to give consent No written informed consent Participation to another study at the same time Rectal tumor Rectal stenosis Ileo-anal or ileo-rectal anastomosis Anal fissure Anal fistula

Exclusion Criteria

Not provided