NCT02296008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

3.8 years

First QC Date

November 12, 2014

Last Update Submit

November 12, 2018

Conditions

ChildrenAnorectal DisorderAnorectal AtresiaHirschsprung Disease

Keywords

high resolution manometrychildrencongenital anorectal disordersurgery

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 will be recorded in mmHg

    20 minutes

Secondary Outcomes (6)

  • Presence of rectoanal inhibitory reflex

    5 minutes

  • Presence of sphincteric lesion in 3D picture of anal canal

    30 seconds

  • Presence of ano-anal reflex

    10 seconds

  • Presence of cough reflex

    10 seconds

  • Presence of discomfort during procedure

    20 minutes

  • +1 more secondary outcomes

Study Arms (3)

surgery for Hirschsprung's disease

OTHER

children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure

Device: 3D high resolution anorectal manometry

surgery for anorectal malformation

OTHER

children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure

Device: 3D high resolution anorectal manometry

surgery for other disorders

OTHER

children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure

Device: 3D high resolution anorectal manometry

Interventions

3D high resolution anorectal manometryDEVICE

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.

surgery for Hirschsprung's diseasesurgery for anorectal malformationsurgery for other disorders

Eligibility Criteria

Age12 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Gastroenterology and Nutrition

Warsaw, 01-184, Poland

Location

Related Publications (1)

  • Banasiuk M, Dziekiewicz M, Dembinski L, Piotrowski D, Kaminski 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.

    PMID: 33877661DERIVED

MeSH Terms

Conditions

Rectal DiseasesAnorectal MalformationsHirschsprung Disease

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMegacolonColonic Diseases

Study Officials

  • Marcin Banasiuk, MD

    Department of Pediatric Gastroenterology and Nutrition Medical University of Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 20, 2014

Study Start

April 1, 2013

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

PL(1)