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

Primary Purpose

Anorectal Disorder, Fecal Incontinence, Constipation

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Anorectal 3D-high resolution manometry

Anorectal radial endosonography (rotative 360° probe)

Dynamic anorectal endosonography (sagittal and radial)

About this trial

This is an interventional diagnostic trial for Anorectal Disorder focused on measuring Primary esophageal achalasia, endoscopic myotomy, high resolution manometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

Unité d'Exploration Fonctionnelle Digestive Hôpital Edouard Herriot

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

ARM 1 Healthy Volunteers

ARM 2: Patients with fecal incontinence

ARM 3 Patients with constipation

Arm Description

Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

presence of ano-rectal reflex.

Ano-rectal radial endosonography

Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest

Dynamic ano-rectal endoconography

presence of pelvic floor disorder (rectocele, enterocele)

Full Information

NCT ID

NCT01710579

First Posted

September 14, 2012

Last Updated

May 23, 2019

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT01710579

Brief Title

Normal Values in Ano-rectal 3D High Resolution Manometry

Acronym

NOMAD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorectal Disorder, Fecal Incontinence, Constipation

Keywords

Primary esophageal achalasia, endoscopic myotomy, high resolution manometry

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

127 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARM 1 Healthy Volunteers

Arm Type

Other

Arm Description

Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography

Arm Title

ARM 2: Patients with fecal incontinence

Arm Type

Other

Arm Description

Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography

Arm Title

ARM 3 Patients with constipation

Arm Type

Other

Arm Description

Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography

Intervention Type

Procedure

Intervention Name(s)

Anorectal 3D-high resolution manometry

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Anorectal radial endosonography (rotative 360° probe)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Dynamic anorectal endosonography (sagittal and radial)

Intervention Description

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

Primary Outcome Measure Information:

Title

Anal pressure pattern at rest, during voluntary maximal squeezing and bear down Anal pressure pattern at rest, during voluntary maximal squeezing and bear down

Description

Following parameters will be measured at the level of anal sphincter: Minimal pressure (amplitude and location) Maximal pressure (amplitude and location) Mean pressure Asymmetry

Time Frame

during procedure

Secondary Outcome Measure Information:

Title

presence of ano-rectal reflex.

Time Frame

during procedure

Title

Ano-rectal radial endosonography

Description

Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest

Time Frame

During procedure

Title

Dynamic ano-rectal endoconography

Description

presence of pelvic floor disorder (rectocele, enterocele)

Time Frame

During procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Unité d'Exploration Fonctionnelle Digestive Hôpital Edouard Herriot

City

Lyon

ZIP/Postal Code

69437

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

28251732

Citation

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.

Results Reference

result

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