Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Presence of retrograde movement of radioactive material (yes/no)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients operated with any type of surgery for Hirschsprung's disease between 1985-2014
- •Age > 15 years
排除标准
- •Unable to understand given instructions in relation to the defecography (ex. retarded)
- •Pregnancy
- •Missing consent
结局指标
主要结局
Presence of retrograde movement of radioactive material (yes/no)
时间窗: 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
时间窗: 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.
Evacuation fraction (%) of radioactive material between first, second and third round of scintigraphic imaging
时间窗: Day 1
The fraction of evacuated radioactive material by defecation between rounds of scintigraphic imaging
Type of surgical intervention performed in each individual (for example pull-through surgery)
时间窗: Day 1
Type of surgical intervention performed to treat Hirschsprung's disease
次要结局
未报告次要终点