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

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.

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: Day 1

The fraction of evacuated radioactive material by defecation between rounds of scintigraphic imaging
Presence of retrograde movement of radioactive material (yes/no)

Time frame: Day 1

Presence of retrograde movement of radioactive material within the bowel on scintigraphic images between rounds of scintigraphic imaging
Hirschsprung and Anorectal Malformations Quality of life Questionnaire sub scales and total score

Time frame: Day 1

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

Time frame: Day 1

Type of surgical intervention performed to treat Hirschsprung's disease

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jul 12, 2021
Registry last updated: Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed