The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection
The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection: A Randomized Controlled Trial
Colorectal cancer is the second most common cancer in the world and the second leading cause of cancer-related mortality. Colorectal cancers arise from precursor adenomatous polyps in a well characterized adenoma to carcinoma progression. The removal of such precursor lesions reduces colorectal cancer mortality between 30 to 50%. Colonoscopy is used for detection of neoplastic polyps but significant miss rates of such lesions are reported. Methods to reduce spasm of the colon have been investigated to increase adenoma detection rates including the use of warm water irrigation and hyoscine butyl bromide. Carbon dioxide warmed to body temperature is postulated to have spasmolytic effects. Administration of warmed carbon dioxide during colonoscopy may improve polyp detection.
Objective: In this study, colonoscopy using warmed carbon dioxide insufflation will be compared to standard room temperature air insufflation to see if there is a greater detection of polyps per patient.
Methods: Patients undergoing colonoscopy for screening and surveillance indications will be included and randomized to receive either room temperature room air or warmed carbon dioxide (37 degrees Celsius). Endoscopists and patients will be blinded to the intervention. Data on indication, preparation, sedation, withdrawal time will be recorded. Polyp detection rate will be the primary outcome. Secondary outcomes will include adenoma detection rate and advanced lesion detection rates.
調査の概要
状態
詳細な説明
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
-
-
Ontario
-
Kingston、Ontario、カナダ、K7L5G2
- Hôtel Dieu 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
説明
Inclusion Criteria:
-outpatients undergoing routine screening or surveillance colonoscopy for colorectal cancer and / or polyp surveillance at Hotel Dieu Hospital
Exclusion Criteria:
- patients who have undergone colonic resections
- active inflammatory bowel disease
- hereditary polyposis syndromes
- moderate to severe chronic obstructive pulmonary disease
- obstructive sleep apnea requiring continuous positive airway pressure or biphasic positive airway pressure
- neurologic diagnoses affecting ventilation
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
- 主な目的:診断
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Warmed Carbon Dioxide Insufflation
warmed carbon dioxide insufflation used in colonoscopy
|
comparator arm
|
アクティブコンパレータ:Room Temperature Air Insufflation
room temperature air insufflation used in colonoscopy
|
control arm
|
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 |
---|---|
Polyp Detection Rate
時間枠:time of endoscopy
|
time of endoscopy
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
adenoma detection rate
時間枠:2 weeks
|
2 weeks
|
advanced lesion per patient detection rate
時間枠:2 weeks
|
2 weeks
|
その他の成果指標
結果測定 |
時間枠 |
---|---|
cecal intubation rate
時間枠:day of colonoscopy
|
day of colonoscopy
|
withdrawal time
時間枠:day of colonoscopy
|
day of colonoscopy
|
anesthetic doses
時間枠:day of colonoscopy
|
day of colonoscopy
|
quality of bowel preparation
時間枠:day of colonoscopy
|
day of colonoscopy
|
patient comfort by a validated nurse administered comfort score
時間枠:day of colonoscopy
|
day of colonoscopy
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Lawrence Hookey, MD、Queens University
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 (実際)
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。