Normal Values for 3D High Resolution Anorectal Manometry in Children

NCT02236507 | Completed

• 1 other identifier: Banasiuk2014 A
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal area. Normal values in pediatric population have not been established. The aim of this study is complex evaluation of anorectal function in children without symptoms from lower GI tract and establishment of normal values.

Conditions

Children; Anorectal Disorder

Outcome Measures

Primary Outcomes (1)

• Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal

  Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible

  up to 20 minutes

Secondary Outcomes (5)

• Presence of Rectoanal Inhibitory Reflex

  up to 5 minutes

• Presence of dyssynergic defecation

  up to 1 minute

• Presence of Cough Reflex

  10 seconds

• Presence of Ano-anal Reflex

  10 seconds

• Presence of discomfort during the procedure

  up to 20 minutes

Study Arms (1)

children without anorectal disorders

OTHER

All children will be investigated by 3D high resolution anorectal manometry procedure

Device: 3D high resolution anorectal manometry

Interventions

3D high resolution anorectal manometry DEVICE

Procedure will take about 15 min. During procedure resting, voluntary squeeze, bear down maneuver, cough reflex, ano-anal reflex and Rectoanal Inhibitory Reflex will be obtained, if possible.

children without anorectal disorders

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• parental agreement
• age: 1 to 18 yr

You may not qualify if:

• parental disagreement
• children younger than 1 yr
• children after the surgery for anorectal malformations
• children with constipation during the last 10 months
• children with nonretentive fecal soiling
• children with inflammatory bowel diseases or any other type of large bowel inflammation
• children with anal fissure, anal varices, inflammation of the anorectal area or any other disease that may interfere with function of anorectum

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Department of Pediatric Gastroenterology and Nutrition

Warsaw, 01-184, Poland

Location

Related Publications (1)

• Banasiuk M, Banaszkiewicz A, Dziekiewicz M, Zaleski A, Albrecht P. Values From Three-dimensional High-resolution Anorectal Manometry Analysis of Children Without Lower Gastrointestinal Symptoms. Clin Gastroenterol Hepatol. 2016 Jul;14(7):993-1000.e3. doi: 10.1016/j.cgh.2016.01.008. Epub 2016 Jan 25.

  PMID: 26820403 DERIVED

MeSH Terms

Conditions

Rectal Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Marcin Banasiuk, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 31, 2014
• First Posted: September 10, 2014
• Study Start: April 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

PL (1)