Randomized Controlled Trial Comparing Water vs. Air Method for Performing Colonoscopy in Adult Female Subjects
This is a prospective , single center, investigator initiated, randomized controlled trial to compare two methods of performing colonoscopy by experienced colonoscopist. Potential female subjects presenting for colonoscopy at UCD GI Lab will be presented with the study option and will be enrolled if they sign the informed consent.
In recent years, the water infusion method has been reported to have several beneficial effects when studied in veteran patients. These include: significant reduction in discomfort to permit a significantly higher percentage (98% vs. 76%) of veterans to complete scheduled unsedated colonoscopy, lower sedation medication requirement when they accepted the option of minimal pre-medication sedation, more patients completing without sedation (78% vs 54%) when they accepted the on demand sedation and an increase in the yield of adenomas (a type of cancer seen in the colon) in screening and surveillance colonoscopy. Reviewers of the method have repeatedly called for studies using the method in female patients to confirm or refute the findings as most of the veteran patients are male patients.
調査の概要
状態
条件
詳細な説明
Study Aim Our aim is to perform a randomized controlled trial comparing air insufflation colonoscopy (conventional method ) vs. water infusion colonoscopy ( study method ) in non veteran female subjects presenting for colonoscopy . Subjects will be randomized 1:1 like the flip of coin.
Study Design This is a prospective, single center, investigator initiated, randomized controlled trial (RCT) to compare the study method (water infusion colonoscopy) with conventional method (air insufflation colonoscopy "pump air to dilate the colon to visualize the colon mucosa) in female patients by experienced colonoscopist. Patients will be classified ASA 1 (No organic, physiologic, biomedical or psychiatric disturbance) and ASA 2 (Mild to moderate systemic diseases which are well controlled including hypertension, diabetes mellitus, asthma, age 70 and over) before colonoscopy procedure.
Research Methods and Procedures The air (conventional) method: Air is pumped gently (insufflation) into the colon will be used to open the inside space of the colon and aid in colonoscope insertion The water (study) method: Warm water (body temperature) will be pumped into the colon in place of air to open the inside of space of the colon and aid in colonoscope insertion After insertion, both methods may use any of the following procedures to advance the colonoscope in to the colon: colonoscope shortening maneuver, abdominal compression, by the assistant, and change of patient position. In both methods air insufflation will be used to distend the colon for inspection, biopsy and polypectomy. Washing of the stool covered mucosa and inspection behind the folds will be performed systematically. After turn around in the rectum, residual air and water will be removed by suction.
Data gathering instruments used in the VA studies will be employed (subject interview questions are attached). Statistical analyses similar to those used in the previous VA studies (Student's t tests, Fischer's exact test, Mann-Whitney U test, etc) will be used to analyze the data.
Biopsy and polypectomy will be performed as usual and all tissues will be submitted for routine histological assessment and the pathology will be recorded.
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
-
-
California
-
Sacramento、California、アメリカ、95817
- University of California, Davis
-
-
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:
-All female patients between the ages of 18 to 80 years scheduled for colonoscopy at UC Davis GI Lab.
Exclusion Criteria:
- Patients who refuse to be randomized to the air or water colonoscopy method.
- Patients who are unable to respond to study questionnaires.
- Patients with partial colon resection
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：water colonoscopy
The water (study) method: Warm water (body temperature) will be infused into colon to open the lumen for water infusion colonoscopy.
Higher rate of complete colonoscopy will be achieved.
|
他の名前：
|
|
アクティブコンパレータ：Air Colonoscopy
The air (conventional) method: Air is pumped gently (insufflation) into the colon will be used to open the inside space of the colon and aid in colonoscope insertion
|
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 |
|---|---|---|
|
Cecal intubation
時間枠：Three years
|
Examination of the cecum by endoscopy
|
Three years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Amount of opiate and benzodiazepines used for sedation.
時間枠：Three years
|
The total amount of opiate (either demerol of fentanyl) used for sedation.
|
Three years
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient discomfort Patient pain rating during and after procedure
時間枠：Three years
|
Patient's pain score (on a 1-10 scale) during and after the procedure.
|
Three years
|
協力者と研究者
捜査官
- 主任研究者：Surinder Mann, M.D.、UCD
研究記録日
主要日程の研究
研究開始 (実際)
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。