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

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.

Study Overview

• Status: Completed
• Conditions: Children; Hirschsprung Disease; Anorectal Disorder; Anorectal Atresia
• Intervention / Treatment: Device: 3D high resolution anorectal manometry

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-184
    • Department of Pediatric Gastroenterology and Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age:1-18 yr
• after surgery for Hirschsprung's disease,
• after surgery for Anorectal malformations,
• after total procto/colectomy
• with parental agreement for the procedure

Exclusion Criteria:

• parental disagreement
• children <12 months of age and >18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: surgery for Hirschsprung's disease; children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure	Device: 3D high resolution anorectal manometry; Procedure will take about 15 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible. 3D picture of pressures of anorectal will be recorded.
Other: surgery for anorectal malformation; children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure	Device: 3D high resolution anorectal manometry; Procedure will take about 15 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible. 3D picture of pressures of anorectal will be recorded.
Other: surgery for other disorders; children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure	Device: 3D high resolution anorectal manometry; Procedure will take about 15 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible. 3D picture of pressures of anorectal will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal	pressures will be recorded in mmHg	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of rectoanal inhibitory reflex	Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex	5 minutes
Presence of sphincteric lesion in 3D picture of anal canal		30 seconds
Presence of ano-anal reflex	an increase in pressure during small movement of catheter inside and outside of the anal canal will be recorded by the sensors	10 seconds
Presence of cough reflex	an increase in pressure during cough will be recorded by the sensors	10 seconds
Presence of discomfort during procedure		20 minutes
Presence of dyssynergic defecation	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	2 minutes

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Medtronic - MITG
• Investigators: Principal Investigator: Marcin Banasiuk, MD, Department of Pediatric Gastroenterology and Nutrition Medical University of Warsaw, Poland

Publications and helpful links

General Publications

• Banasiuk M, Dziekiewicz M, Dembiński Ł, Piotrowski D, Kamiński A, Banaszkiewicz A. Three-dimensional high-resolution anorectal manometry in children after surgery for anorectal disorders. Eur Rev Med Pharmacol Sci. 2021 Apr;25(7):2981-2993. doi: 10.26355/eurrev_202104_25551.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: surgery; children; high resolution manometry; congenital anorectal disorder
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Congenital Abnormalities; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Digestive System Abnormalities; Megacolon; Disease; Anorectal Malformations; Hirschsprung Disease; Rectal Diseases
• Other Study ID Numbers: Banasiuk2014 B