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

Hirschsprung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957667
• Other study ID #: HD-NQ-2018
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2022
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Hirschsprung's disease (HD) is a congenital deficiency with incomplete development of nerves in the gastrointestinal tract leading to absence of peristalsis in the affected segment of bowel. Most patients require surgical intervention with removal of the affected segment of bowel. Physical symptoms affecting quality of life are not uncommon in patients born with HD in spite of surgical intervention. This renders a need for a tool for evaluating the functional outcome in these patients. Scintigraphic defecography examines the defecation in terms of the ability to empty the bowel and examines the relocation of faeces within the bowel in relation to defecation. This study aims to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire (Hirschsprung and Anorectal Malformations Quality of Life Questionnaire).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hirschsprung Disease

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Region Syddanmark

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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