Normal Values in Ano-rectal 3D High Resolution Manometry

NCT01710579 | Completed DMC

• 1 other identifier: 2012.729
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorectal Disorder; Fecal Incontinence; Constipation

Keywords

Primary esophageal achalasia; endoscopic myotomy; high resolution manometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• presence of ano-rectal reflex.

  during procedure

• Ano-rectal radial endosonography

  During procedure

• Dynamic ano-rectal endoconography

  During procedure

Study Arms (3)

ARM 1 Healthy Volunteers

OTHER

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

Procedure: Anorectal 3D-high resolution manometry; Procedure: Anorectal radial endosonography (rotative 360° probe); Procedure: Dynamic anorectal endosonography (sagittal and radial)

ARM 2: Patients with fecal incontinence

OTHER

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

Procedure: Anorectal 3D-high resolution manometry; Procedure: Anorectal radial endosonography (rotative 360° probe); Procedure: Dynamic anorectal endosonography (sagittal and radial)

ARM 3 Patients with constipation

OTHER

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

Procedure: Anorectal 3D-high resolution manometry; Procedure: Anorectal radial endosonography (rotative 360° probe); Procedure: Dynamic anorectal endosonography (sagittal and radial)

Interventions

Anorectal 3D-high resolution manometry PROCEDURE

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

ARM 1 Healthy Volunteers; ARM 2: Patients with fecal incontinence; ARM 3 Patients with constipation

Anorectal radial endosonography (rotative 360° probe) PROCEDURE

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

ARM 1 Healthy Volunteers; ARM 2: Patients with fecal incontinence; ARM 3 Patients with constipation

Dynamic anorectal endosonography (sagittal and radial) PROCEDURE

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

ARM 1 Healthy Volunteers; ARM 2: Patients with fecal incontinence; ARM 3 Patients with constipation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Arm 2: 50 patients with fecal incontinence
• 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
• 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
• 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
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Unité d'Exploration Fonctionnelle Digestive Hôpital Edouard Herriot

Lyon, 69437, France

Location

Related Publications (1)

• 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.

  PMID: 28251732 RESULT

MeSH Terms

Conditions

Rectal Diseases; Fecal Incontinence; Constipation

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: October 19, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 28, 2019

Record last verified: 2012-09

Locations

FR (1)