Quality of Life in Patients With Hirschsprung's Disease in Relation to Surgical Technique: a Study of a Danish Population
试验速览
- 阶段
- 不适用
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- General Quality of Life
研究概览
简要总结
This is an observational study examining the long-term quality of life in patients with Hirschsprung's Disease in relation to the choice of surgical technique.
详细描述
Hirschsprung's Disease (HD) is a developmental defect causing functional obstruction of bowel. It is a condition that almost always requires surgical intervention. This study aims to examine the relation between quality of life and surgical technique in patients with Hirschsprung's disease in hopes of providing insight into advantages and disadvantages of different surgical techniques employed at OUH, department for general surgery in the time between 1985 and 2012. This will be done based on answers given on a set of validated questionnaires that has been sent to all patients diagnosed with HD in the years 1985 to 2012 at OUH, department for general surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with HD at the Surgical Department at Odense University Hospital from 1985 to 2012 will be invited to enroll in the study.
排除标准
- •lack of informed consent, pregnancy, wrong diagnosis and inability to understand or answer the questionnaires.
结局指标
主要结局
General Quality of Life
时间窗: Day 1
Based on a generic SF-36 questionnaire subscaled into perception of health, physical functioning, physical role functioning, emotional functioning and emotional role functioning. Each question is phrased as a multiple-choice question with varying options depending on the type of question.
Type of Surgical Intervention
时间窗: Day 1
At our centre three different types of surgical approaches have been employed: Soave operation, Low anterior resection (Rehbeins operation) and trans-anal pullthrough. These outcomes will be correlated to outcomes of quality of life in other to compare the resulting quality of life between the different surgical approaches.
Hirschsprung 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.
次要结局
- Rate of Complications(Day 1)
研究者
Christoffer Cain Hansen
Student
University of Southern Denmark