Evaluate the Safety and Diagnostic Advantages of Tilt Down Verses Standard Horizontal Colonoscopy Positioning (CTDTTIE)
The Effect of Body Positioning for Colonoscopy in Women: Randomized, Study of Left Lateral Tilt Down Versus Left Lateral Horizontal Positioning
調査の概要
詳細な説明
This was a prospective, randomized study. Subjects who provide informed consent and present to the offices of Specialists in Gastroenterology for colonoscopy will be randomized in a 1:1 distribution to either left lateral tilt down versus left lateral horizontal positioning to initiate colonoscopy.
Demographic data as well as routine information regarding the colonoscopy was filled out during or at the end of each procedure. In addition, the following parameters were assessed, and compared between groups:
- Occurrence of complications related or possibly related to the colonoscopy procedure
- Scope insertion time
- Pain during and after the procedure
The subjects' participation was limited to the duration of the colonoscopy, which is typically less than 60 min and a follow up by telephone 24 hours later to assess the occurrence of complications.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Missouri
-
St. Louis、Missouri、アメリカ、63141
- Advanced Endoscopy Center
-
-
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
説明
Inclusion Criteria:
- ability to understand and sign consent
- women and men with a BMI (body mass index) <35 kg/m2
- age 18 - 90 years
- no liquids by mouth for ≥2 hours
- no solid food for ≥8 hours
Exclusion Criteria:
- inability to provide informed consent
- morbid obesity (BMI ≥35)
- pregnancy
- uncontrolled gastroesophageal reflux disease
- gastroparesis
- scleroderma
- achalasia
- Crohn's disease
- ulcerative colitis
- history of a colon resection
- Parkinson's disease
- brain tumor
- multiple sclerosis
- ischemic optic neuropathy
- glaucoma
- active pulmonary infection
- liquid intake <2 hours
- solid food intake <8 hours prior to the procedure
- intra-procedure findings of a stricture resulting in an incomplete colonoscopy or Boston bowel preparation scores of <6
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
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Lateral horizontal body position
Subjects randomized to receive colonoscopy in the lateral horizontal position, This is the standard position.
The other position - tilt down is the intervention
|
colonoscopy in the lateral horizontal position with tilt down
|
|
他の：Lateral tilt down body position
Subjects randomized to receive colonoscopy in the lateral tilt down position
|
colonoscopy in the lateral horizontal position with tilt down
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure
時間枠：24 hours
|
The number of participants who experience adverse events which are related or possibly related to the colonoscopy procedure will be tallied in each treatment arm.
|
24 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Full Colonoscope Insertion
時間枠：30 minutes
|
30 minutes
|
|
|
Pain Related or Possibly Related to Colonoscopy Procedure
時間枠：24 hours
|
Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain.
|
24 hours
|
協力者と研究者
捜査官
- 主任研究者：Leonard B Weinstock, MD、Specialists in Gastroenterology, LLC
出版物と役立つリンク
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。