Clinical Trial: 3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders

Brief Summary:

3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function and 3D topographic picture of pressures along the anal canal.

Until now, it has been used only in adult population to evaluate defecatory disorders.

Congenital anorectal disorders are severe conditions and may present wide spectrum of symptoms from gastrointestinal tract.

The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal disorders such as Hirschsprung's disease and anorectal malformations.

It may help for better understanding of pathophysiology of anorectal area and allow for planning improved procedures in these patients.

Moreover, the investigators study may elucidate the real usefulness of the procedure in management of disorders of gastrointestinal tract in pediatric population.


Detailed Summary:
Sponsor: Medical University of Warsaw

Current Primary Outcome: Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal [ Time Frame: 20 minutes ]

pressures will be recorded in mmHg


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Presence of rectoanal inhibitory reflex [ Time Frame: 5 minutes ]
    Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex
  • Presence of sphincteric lesion in 3D picture of anal canal [ Time Frame: 30 seconds ]
  • Presence of ano-anal reflex [ Time Frame: 10 seconds ]
    an increase in pressure during small movement of catheter inside and outside of the anal canal will be recorded by the sensors
  • Presence of cough reflex [ Time Frame: 10 seconds ]
    an increase in pressure during cough will be recorded by the sensors
  • Presence of discomfort during procedure [ Time Frame: 20 minutes ]
  • Presence of dyssynergic defecation [ Time Frame: 2 minutes ]
    during bear down maneuver lasting 20 second and repeated 2 times with the resting period of 1 minute the configuration of pressures inside the rectum and anal canal will be recorded and analyzed according to the criteria of dyssynergic defecation


Original Secondary Outcome: Same as current

Information By: Medical University of Warsaw

Dates:
Date Received: November 12, 2014
Date Started: April 2013
Date Completion: December 2015
Last Updated: July 1, 2015
Last Verified: July 2015