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

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ClinicalTrials.gov Identifier: NCT04149093
Recruitment Status : Not yet recruiting
First Posted : November 4, 2019
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Nelson Piche, St. Justine's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Hirschsprung Disease Ganglion Hirschsprung Disease, Long-Segment Hypoganglionosis Diagnostic Test: Calretinin staining

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Association Between Calretinin and the Function of Ganglion Cells in Long Segment and Total Hirschsprung Disease
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020



Intervention Details:
  • Diagnostic Test: Calretinin staining

    A paraffin-embedded hematoxylinphloxin-safran sections will be performed on tissue specimens of proximal resection margins to evaluate the presence or absence of ganglion cells.

    Immunohistochemistry (IHC) will then be done on paraffin-embedded sections for calretinin staining.

    Other Name: Immunohistochemistry


Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. 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)



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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Hirschsprung disease and a transition zone more proximal to the distal sigmoid
Criteria

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

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Responsible Party: Nelson Piche, Principal Investigator, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT04149093    
Other Study ID Numbers: 2020-2597
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ganglion Cysts
Synovial Cyst
Hirschsprung Disease
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities