An interventional study of Anorectal 3D-high resolution manometry and Anorectal radial endosonography (rotative 360° probe) in Anorectal Disorder, Fecal Incontinence and Constipation, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-28.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
Among 32 studies in Fecal Incontinence with a site in France — 7 open to participants now, 7 under way, 2 of them phase 3. Fecal Incontinence · France.
Among the 32 studies in Fecal Incontinence with a site in France, this one is the 6th largest by enrollment of the 17 interventional ones, is one of 6 that started in 2012, is one of 10 with no phase, and was the 11th registered.
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
This study's enrollment of 127 is above the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →7 of the 32 studies in Fecal Incontinence with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 38 Fecal Incontinence studies recruiting now, 25 (66%) set no upper age limit and 9 (24%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 6 started in 2012.
Median enrollment 71 across the 17 interventional studies, 85 across the 15 observational. Of the 24 that completed or were terminated, 3 (13%) have results posted.
7 of 32 have an industry lead sponsor. The 10 most frequent:
Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Hospices Civils de Lyon has 1 study filed under Fecal Incontinence — fewer than ten, so there is no comparison to draw.
2 of the studies in Fecal Incontinence with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05998187Phase 3University Hospital, RouenMechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections | 2027-06-01 |
| NCT04972799Rennes University HospitalEvaluation of the Efficacy and Safety of Autologous Fat Injection Into the Intersphincter Space in Fecal Incontinence: a Randomized, Placebo-controlled, Cross-over, Double-blind Trial | 2026-11 |
Among the 32 studies in Fecal Incontinence with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
This study's enrollment of 127 is above the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Compared within Fecal Incontinence, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Rectal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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)
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
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
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
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
Time frame: during procedure
presence of ano-rectal reflex.
Time frame: during procedure
Ano-rectal radial endosonography
Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest
Time frame: During procedure
Dynamic ano-rectal endoconography
presence of pelvic floor disorder (rectocele, enterocele)
Time frame: During procedure
The record gives a start of Sep 2012, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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