Registry for Hirschsprung Disease of the BELAPS

Registry for Hirschsprung Disease of the BELAPS (Belgian Association of Pediatric Surgery)

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

Study Overview

• Status: Recruiting
• Conditions: Hirschsprung Disease

• Study Type: Observational
• Enrollment (Estimated): 432

Contacts and Locations

• Study Contact: Name: Colette Barle; Email: colette.barle@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Colette Barlé; Phone Number: ++32 16 341699; Email: colette.barle@uzleuven.be
    • Principal Investigator: Marc Miserez, Prof.Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

Inclusion Criteria:

Hirschsprung Disease, surgery

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Digestive System Abnormalities; Megacolon; Hirschsprung Disease
• Other Study ID Numbers: S51836

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No