The Association Between Calretinin and the Function of Ganglion Cells in Hirschsprung Disease

March 15, 2021 updated by: Nelson Piche, St. Justine's Hospital

The Association Between Calretinin and the Function of Ganglion Cells in Long Segment and Total Hirschsprung Disease

This study aims to compare the outcomes of patients with long segment Hirschsprung disease or total colonic aganglionosis who had negative calretinin staining and positive ganglion cells on the proximal resection margins to those who had both positive findings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Hirschsprung disease and a transition zone more proximal to the distal sigmoid

Description

Inclusion Criteria:

  • Confirmed histopathological diagnosis of Hirschsprung disease from January 1, 1990 to August 31, 2019
  • Long-segment Hirschsprung disease (type A and B)
  • Total colonic aganglionosis (TCA)
  • Surgery at CHUSJ
  • Tissue blocks of proximal resection margin available for pathological analysis
  • Minimum 1 month of postoperative follow-up

Exclusion Criteria:

  • Short-segment Hirschsprung disease (conventional form, rectosigmoid junction)
  • Total colonic with small bowel aganglionosis (TCSA)
  • Surgery done at another institution
  • Early deaths
  • Lost to follow-up
  • No documented post-operative outcome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term outcomes (Quality of life questionnaire)
Time Frame: 1 year

To determine if calretinin has a role in the function of ganglion cells in long segment Hirschsprung disease and total colonic aganglionosis.

HAQL (Hirschsprung's disease and Anorectal malformations Quality of Life) questionnaire. For each item the response is scored from 0 to 3 and then, linearly transformed to a 0 (minimum value) to 100 (maximum value) scale. Higher score suggests a better quality of life.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical complications
Time Frame: 1 year
  • Number of reoperations
  • Number of rebiopsies
  • Number of readmissions
  • Number of bowel obstructions
  • Number of bowel perforation
  • Number of anastomotic leaks
  • Number of anastomotic strictures
  • Number of fistula
  • Number of anal stenosis
  • Number of Hirschsprung-associated enterocolitis
1 year
Functional outcomes
Time Frame: 1 year
  • Presence of constipation (yes/no)
  • Presence of diarrhea (yes/no)
  • Presence of incontinence and soiling (yes/no)
  • Presence of abdominal distension (yes/no)
  • Presence of dependance on enemas/medications (yes/no)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-2597

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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