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临床试验/NCT02624232
NCT02624232Unknown不适用

Long-term Outcome in Patients Operated for Congenital Anorectal Malformations

Odense University Hospital0 个研究点目标入组 60 人开始时间: 2016年1月最近更新:
适应症

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:

  1. Assessment of bowel function and QoL through relevant questionnaires
  2. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Bjørsum-Meyer

M.D.,ph.d-student

Odense University Hospital

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