Diurnal Variation in Rectal Diameter
Diurnal Variation in Rectal Diameter Measured by Transabdominal Ultrasound in Healthy and Constipated Children.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Kolding、デンマーク、6000
- Pediatric department, Kolding Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Constipated children are recruited from the outpatient clinic at Kolding pediatric department. A list of patients which have been given the diagnose constipation are drawn from the computer and reviewed. Children between 4-12 years who fulfill the Rome III criteria of constipation and have been taking PEG maintenance treatment at least 1 month, are contacted by telephone for possible participation in the study.
Healthy participants without constipation or other diseases affecting the gastrointestinal tract were recruited among the employees of the Department of Pediatrics at Kolding Hospital.
Written informed consent was obtained from both parents before any procedures were initiated.
説明
Constipated Inclusion Criteria:
- Children from 4 to 12 years with previously diagnosed simple constipation defined by ROME III criteria, which at inclusion is in maintenance therapy with PEG + E and has been in treatment for at least 1 month.
Exclusion Criteria:
- Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
- Children receiving drugs known to affect bowel function during a 2 month period before initiation besides laxatives.
Healthy inclusion Criteria:
- Children between 4 and 12 years of age.
Healthy exclusion Criteria:
- Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
- Children receiving drugs known to affect bowel function during a 2 month period before initiation.
- Children with a previous history of constipation, fecal incontinence and / or urinary tract infections.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Healthy
Transabdominal ultrasound
|
Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.
|
|
Constipated
Transabdominal ultrasound
|
Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Rectal diameter
時間枠:24 hours
|
24 hours
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Line Modin, MD、Kolding Sygehus
- スタディディレクター:Marianne Jakobsen, MD, phd、Kolding Sygehus
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。