Normal Values in Ano-rectal 3D High Resolution Manometry (NOMAD)

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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69437
    • Unité d'Exploration Fonctionnelle Digestive Hôpital Edouard Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ARM 1 Healthy Volunteers; Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography	Procedure: Anorectal 3D-high resolution manometry; Anorectal probe is used with a single-use protective sheath with an inflation balloon Control of balloon deflation Patient in left lateral decubitus position with hips flexed to 90° (this position is the most commonly use and the most convenient) Transanal insertion 2 minutes resting period: resting anal pressure will be evaluated the second minute of rest Sustained voluntary maximal squeeze for at least 30 seconds; the maneuver will be repeated once Valsalva Bear down maneuver; the maneuver will be repeated once Anorectal reflexes evaluation with 20-, 40- and 60-ml intra-rectal balloon inflation Probe removal; Procedure: Anorectal radial endosonography (rotative 360° probe); Patient in left lateral decubitus position with hips flexed to 90° Transanal probe insertion Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest; Procedure: Dynamic anorectal endosonography (sagittal and radial); Patient in left lateral decubitus position with hips flexed to 90° Rectum is filled with 50-ml water Probe is covered with a water-filled balloon to maintain the acoustic window for the ultrasound wave Transanal probe insertion Slow and manual rotation of the linear probe through 360° to identify the various layers constituting the anal wall (mucosa, IAS, EAS), the layer forming the rectal wall and the perirectal tissues (puborectalis muscle, bladder, and vagina or prostate) After the initial examination, the patient will be asked to make a defecation effort with the probe left in the same position
Other: ARM 2: Patients with fecal incontinence; Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography	Procedure: Anorectal 3D-high resolution manometry; Anorectal probe is used with a single-use protective sheath with an inflation balloon Control of balloon deflation Patient in left lateral decubitus position with hips flexed to 90° (this position is the most commonly use and the most convenient) Transanal insertion 2 minutes resting period: resting anal pressure will be evaluated the second minute of rest Sustained voluntary maximal squeeze for at least 30 seconds; the maneuver will be repeated once Valsalva Bear down maneuver; the maneuver will be repeated once Anorectal reflexes evaluation with 20-, 40- and 60-ml intra-rectal balloon inflation Probe removal; Procedure: Anorectal radial endosonography (rotative 360° probe); Patient in left lateral decubitus position with hips flexed to 90° Transanal probe insertion Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest; Procedure: Dynamic anorectal endosonography (sagittal and radial); Patient in left lateral decubitus position with hips flexed to 90° Rectum is filled with 50-ml water Probe is covered with a water-filled balloon to maintain the acoustic window for the ultrasound wave Transanal probe insertion Slow and manual rotation of the linear probe through 360° to identify the various layers constituting the anal wall (mucosa, IAS, EAS), the layer forming the rectal wall and the perirectal tissues (puborectalis muscle, bladder, and vagina or prostate) After the initial examination, the patient will be asked to make a defecation effort with the probe left in the same position
Other: ARM 3 Patients with constipation; Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography	Procedure: Anorectal 3D-high resolution manometry; Anorectal probe is used with a single-use protective sheath with an inflation balloon Control of balloon deflation Patient in left lateral decubitus position with hips flexed to 90° (this position is the most commonly use and the most convenient) Transanal insertion 2 minutes resting period: resting anal pressure will be evaluated the second minute of rest Sustained voluntary maximal squeeze for at least 30 seconds; the maneuver will be repeated once Valsalva Bear down maneuver; the maneuver will be repeated once Anorectal reflexes evaluation with 20-, 40- and 60-ml intra-rectal balloon inflation Probe removal; Procedure: Anorectal radial endosonography (rotative 360° probe); Patient in left lateral decubitus position with hips flexed to 90° Transanal probe insertion Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest; Procedure: Dynamic anorectal endosonography (sagittal and radial); Patient in left lateral decubitus position with hips flexed to 90° Rectum is filled with 50-ml water Probe is covered with a water-filled balloon to maintain the acoustic window for the ultrasound wave Transanal probe insertion Slow and manual rotation of the linear probe through 360° to identify the various layers constituting the anal wall (mucosa, IAS, EAS), the layer forming the rectal wall and the perirectal tissues (puborectalis muscle, bladder, and vagina or prostate) After the initial examination, the patient will be asked to make a defecation effort with the probe left in the same position

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• Mion F, Garros A, Brochard C, Vitton V, Ropert A, Bouvier M, Damon H, Siproudhis L, Roman S. 3D High-definition anorectal manometry: Values obtained in asymptomatic volunteers, fecal incontinence and chronic constipation. Results of a prospective multicenter study (NOMAD). Neurogastroenterol Motil. 2017 Aug;29(8). doi: 10.1111/nmo.13049. Epub 2017 Mar 2.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: September 14, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (Estimate): October 19, 2012

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Primary esophageal achalasia; endoscopic myotomy; high resolution manometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Constipation; Fecal Incontinence; Rectal Diseases
• Other Study ID Numbers: 2012.729

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No