Normal Values in Ano-rectal 3D High Resolution Manometry

NACompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Anorectal DisorderFecal IncontinenceConstipation
Interventions
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

Trial Locations (1)

69437

Unité d'Exploration Fonctionnelle Digestive Hôpital Edouard Herriot, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT01710579 - Normal Values in Ano-rectal 3D High Resolution Manometry | Biotech Hunter | Biotech Hunter