Recruiting

Hirschsprung Disease

Sponsor:

St. Justine's Hospital

Code:

NCT04149093

Conditions

Hirschsprung Disease

Ganglion

Hirschsprung Disease, Long-Segment

Hypoganglionosis

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Calretinin staining

Study Details

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.

Conditions

Hirschsprung Disease

Ganglion

Hirschsprung Disease, Long-Segment

Hypoganglionosis

Study ID

NCT04149093

Start date

May 1, 2020

Status verified date

Mar, 2021

Completion date

Dec 1, 2021

Anticipated

Primary completion date

Sep 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Long-term outcomes (Quality of life questionnaire) [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Contacts

Annie Le-Nguyen, MD

5146929694annie.le-nguyen@outlook.com

More Information

Sponsor

St. Justine's Hospital

Last update posted

Mar 17, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2021-03-17.