- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00230360
Diagnosis of Functional Defecation Disorders in Childhood
연구 개요
상세 설명
Defecation disorders in children are extremely common especially constipation and fecal incontinence. International studies show that constipation make up approximately 3% of Pediatric Outpatient Clinic11 (192) and 25% of Pediatric gastroenterology consultations. Between 1,5-3% of all 4-12 year olds experience fecal incontinence.
Constipation and fecal incontinence can be extremely physical unpleasant and can have significant ramifications for a child's emotional and social functioning eg. low self esteem.
Though most agree that constipation and faecal incontinence are a considerable problem worldwide there is disagreement when it comes to a definition and diagnostic tools. Several definitions have been used. This has led to great difficulties when trying to estimate prevalence, understand and compare in order to improve different treatments.
Hypothesis:
- It is possible to diagnose constipation accurately by using a combination of anamnesis, stool diary, physical examination and transabdominal ultrasonography
- Transabdominal ultrasonography is a safe and sensitive diagnostic tool and can be used as an alternative or substitute to rectal examination.
Purpose To compare different kinds of diagnostic (tools) investigations in order to identify the most sensitive and least invasive when diagnosing constipation.
Material and methods 60 children referred to the paediatric outpatient clinic with fecal incontinence or suspicion of constipation. The investigations include anamnesis and physical examination with rectal examination and transabdominal ultrasonography. Home registration of a stool diary based on the Bristol Scale for 3 weeks thereafter a Colonic transit time is performed.
Data is compared to data from 30 healthy children that have gone through the same investigations except the CTT that is based on x-rays.
연구 유형
등록
연락처 및 위치
연구 장소
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Aarhus, 덴마크, 8200
- Department of Pediatrics, Aarhus University Hospital, Skejby Sygehus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Referred children
- functional constipation and/or fecal incontinence
Healthy children
- No sign of functional constipation and/or fecal incontinence
Exclusion Criteria:
Referred children
- organic constipation/ fecal incontinence
Healthy children
- constipation/ fecal incontinence
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
공동 작업자 및 조사자
수사관
- 수석 연구원: Iben M Jonsson, Med Student, University of Aarhus
- 연구 책임자: Soren Rittig, MD, University of Aarhus
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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