NCT04622410

Brief Summary

Registry for Hirschsprung disease of the BELAPS (Belgian Association of Pediatric Surgery) Protocol Short Title/Acronym / Sponsor name BELAPS Principal Investigator Prof. Dr. Marc Miserez Medical condition or disease under investigation Hirschsprung's disease Purpose of clinical study To register pre-, intra- and postoperative data in order to improve surgical care to paediatric patients with Hirschsprung's disease in Belgium. Primary objective The primary objective is to evaluate defecation habits at 3.5-5.5 years after surgery. Secondary objective (s) Evaluating the long-term results and evaluate risk factors for constipation / incontinence. Study Design Prospective registry Endpoints Krickenbeck score, urinary, sexual and QoL evaluation

Trial Health

77
On Track

Trial Health Score

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

Enrollment
432

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress75%
May 2012Dec 2030

Study Start

First participant enrolled

May 1, 2012

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

18.7 years

First QC Date

November 5, 2020

Last Update Submit

June 28, 2024

Conditions

Hirschsprung Disease

Outcome Measures

Primary Outcomes (1)

  • To register pre-, intra- and postoperative data in order to improve surgical care to pediatric patients with Hirschsprung's disease in Belgium.

    at least 10 years postoperatively

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* All Hirschsprung disease patients consecutively * Male and female * \< 18 years * Operated by a participating surgeon * Elective and emergency surgery * Informed consent form signed by the parents of the child

You may qualify if:

  • Hirschsprung Disease, surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesMegacolonColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Colette Barle

CONTACT

colette.barle@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 10, 2020

Study Start

May 1, 2012

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

July 1, 2024

Record last verified: 2024-06

Locations

BE(1)