Normal Values in Ano-rectal 3D High Resolution Manometry (NOMAD)
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Details and patient eligibility
About
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.
Enrollment
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Ages
Volunteers
Inclusion and exclusion criteria
Arm 1: 50 healthy volunteers Inclusions will be stratified on gender (10 males, 40 females), age (15 subjects under 40 years; 20 subjects between 40 and 60 years; and 15 subjects >60 years) and parous (10 nullipara and 30 parous women).
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
127 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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