Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population

NCT04957667 | Completed

• 1 other identifier: HD-NQ-2018
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate long term outcomes of surgical intervention for Hirschsprung's disease and to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire.

Conditions

Hirschsprung Disease

Keywords

Hirschsprung disease; Scintigraphic defecography

Outcome Measures

Primary Outcomes (4)

• Evacuation fraction (%) of radioactive material between first, second and third round of scintigraphic imaging

  The fraction of evacuated radioactive material by defecation between rounds of scintigraphic imaging

  Day 1

• Presence of retrograde movement of radioactive material (yes/no)

  Presence of retrograde movement of radioactive material within the bowel on scintigraphic images between rounds of scintigraphic imaging

  Day 1

• Hirschsprung and Anorectal Malformations Quality of life Questionnaire sub scales and total score

  Disease specific questionnaire including sub scales for laxative and constipating diet, presence of diarrhoea and constipation, faecal and urinary incontinence, social and emotional functioning, body image, physical symptoms and sexual functioning. Each item is phrased as a multiple-choice question with four response options; never, once in a while, often and very often. Responses are linearly transformed on a 0-100 scale with a higher score indicating better QOL.

  Day 1

• Type of surgical intervention performed in each individual (for example pull-through surgery)

  Type of surgical intervention performed to treat Hirschsprung's disease

  Day 1

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients operated for Hirschsprung's disease from 1985-2014 are gathered in a cohort, intended for several studies on Hirschsprung's disease. All patients \> 15 years from this cohort will be invited to participate in this study.

You may qualify if:

• Patients operated with any type of surgery for Hirschsprung's disease between 1985-2014
• Age \> 15 years

You may not qualify if:

• Unable to understand given instructions in relation to the defecography (ex. retarded)
• Pregnancy
• Missing consent

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: July 12, 2021
• Study Start: February 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

DK (1)