Long-term Outcome in Patients Operated for Congenital Anorectal Malformations
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Correlation between anorectal pathoanatomy and gastrointestinal symptoms/quality of life
研究概览
简要总结
Background Anorectal malformations(ARM) are rare and cover congenital defective development of rectum.
ARM include a range of congenital conditions and may in varying degrees involve the anorectum. A significant part have malformations in other organs mainly the urinary tract.
In the vast majority ARM are recognized at birth by lack of a normal anus. The primary approach is construction of a stoma and subsequent reconstruction. Bowel continuity is typical restored after 4-6 months.
Many patients experience abnormal bowel function later on and affected quality of life(QoL).
Aim
The primary objective is to assess the patient-related outcome 10-30 years after surgery for ARM and to see if it related to existing damage to anorectum and bowel function. The secondary objective is to identify problems with bowel function which may be treated medically or by surgery to improve bowel function and QoL. To obtain the necessary knowledge the study is divided in the following sub-projects:
- Assessment of bowel function and QoL through relevant questionnaires
- Examine sphincter anatomy and function through rectal ultrasound, magnetic resonans(MR)-scan of the pelvis and anal manometry. Bowel function is assessed through colonic transit time. Screening for urinary tract problems with uroflowmetry.
Methods Participants are identified through relevant diagnostic codes(Q 42) and patients which underwent surgery for ARM in the years 1985-2005 are included if informed consent is obtained.
Relevant questionnaires regarding symptoms and QoL are completed before the following examinations:
- Anal manometry
- Anal ultrasound
- Pudenda conduction velocity
- Colonic transit time
- Magnetic resonans(MR)-scan of lower abdomen and pelvis
- Uroflowmetry
Bowel function and QoL is assessed in both children and adults with relevant validated questionnaires.
Perspective No danish studies and only a few foreign investigate the relationship between anatomy/physiology and quality of life after surgery for anorectal malformations.
The investigators believe the study and included comprehensive examinations will clarify the causes of functional problems after surgery for anorectal malformations. Results of questionnaires regarding symptoms, disease-specific-and general quality of life offer a unique opportunity for targeted treatment to improve symptoms and QoL in patients with ARM.
详细描述
Aim
Endpoints The primary endpoints are outcome 10-30 years after surgery for anorectal malformations and to see if it is related to existing altered anatomy, anorectal function and intestinal passage.
The secondary endpoints is to identify bowel function problems which can be treated by medicine or surgery to improve patients bowel function and quality of life.
To obtain the necessary knowledge the study will be divided in the following
Sub-projects:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 31 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery for anorectal malformations
排除标准
- •Severe mental disability
结局指标
主要结局
Correlation between anorectal pathoanatomy and gastrointestinal symptoms/quality of life
时间窗: Up to 6 years
次要结局
- Correlation between gastrointestinal symptoms and quality of life(Up to 6 years)
研究者
Thomas Bjørsum-Meyer
M.D.,ph.d-student
Odense University Hospital
