Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes
2015年11月4日 更新者：Sergio Cadoni, M.D.、Presidio Ospedaliero Santa Barbara
Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial
Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating.
Sufferers often experience a sensation of fullness and abdominal pressure, relieved only after expulsion of the residual gas, often accompanied by colic pain.
This can be a lengthy process, and some patients continue to report pain as long as 24 hours after the procedure.
Abdominal discomfort after colonoscopy is an adverse event commonly reported by patients, and definitely associated with the procedure.
Published reports show that the use of carbon dioxide (CO2) insufflation significantly decreases bloating and pain up to 24 hours post-procedure.
Preliminary results of the investigators' previous study about on-demand sedation colonoscopy in diagnostic patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion of water to distend the lumen during insertion; suction of infused water, residual air pockets an feces predominantly during insertion) achieved significantly lower real-time insertion pain scores.
Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2.
Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences were significant only at discharge.
The investigators decided to conduct a prospective randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2.
The investigators will test the hypothesis that patients examined by the combination of WE-CO2 will have significantly lower bloating scores at specific time points after colonoscopy than those examined using WE-AI or CO2-CO2.
The investigators will also assess the impact of these three methods on patients comfort and activities in the post-procedure period.
調査の概要
詳細な説明
Design: Prospective double blinded two-center randomized controlled trial. Methods: Colonoscopy with CO2 insufflation and water exchange-CO2, water exchange-AI; split-dose bowel preparation; on demand-sedation.
Control method: CO2 insufflation colonoscopy. Study methods: water exchange-CO2 colonoscopy, water exchange-AI colonoscopy.
Population: Consecutive 18 to 80 year-old first-time diagnostic outpatients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
研究の種類
介入
入学 (実際)
246
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- consecutive 18 to 80 year-old first-time diagnostic outpatients agreeing to start procedure without premedication
Exclusion Criteria:
- patient unwillingness to start the procedure without sedation/analgesia
- previous colorectal surgery
- proctosigmoidoscopy or bidirectional endoscopy
- patient refusal or inability to provide informed consent
- inadequate consumption of bowel preparation
- moderate or severe chronic obstructive pulmonary disease requiring oxygen
- medical history of CO2 retention
- history of inflammatory bowel disease
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Carbon dioxide method
Colonoscopy performed as usual, with the minimal CO2 insufflation required to aid insertion and adequate distension during withdrawal for exploration.
Washing allowed as needed.
Considered to be standard procedure.
|
Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.
|
|
実験的：Water Exchange-CO2
Insufflation not used until the cecum is reached.
Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope.
Part of the infused water will be constantly suctioned back exchanging clean for opaque water.
Air pockets and residual feces will be always aspirated.
Withdrawal phase done using carbon dioxide insufflation.
|
Insertion using water exchange, withdrawal using CO2 insufflation.
|
|
実験的：Water Exchange-AI
Insufflation not used until the cecum is reached.
Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope.
Part of the infused water will be constantly suctioned back exchanging clean for opaque water.
Air pockets and residual feces will be always aspirated.
Withdrawal phase done using air insufflation.
|
Insertion using water exchange, withdrawal using air insufflation.
|
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 |
|---|---|---|
|
Change in abdominal bloating sensation after colonoscopy.
時間枠：Within the first 24 hours after the procedure.
|
Change of patients' sensation of abdominal bloating.
Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients.
Measured on an eleven-point Numeric Rating Scale (NRS): 0=none, 10=full bloating.
Results will be recorded by telephone recall.
|
Within the first 24 hours after the procedure.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in pain score after colonoscopy.
時間枠：Within the first 24 hours after the procedure.
|
Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients.
Measured using an eleven-point NRS (0=none, 10=maximum pain).
Results will be recorded by telephone recall.
|
Within the first 24 hours after the procedure.
|
|
Real-time insertion pain.
時間枠：1 hour.
|
Pain assessed using a NRS (0=absence of pain, 2=simply "discomfort", 10=worst pain).
Before the procedure, an endoscopic nurse will explain the NRS scoring system to the patients.
At irregular intervals during colonoscopy (around 60 seconds) assisting nurse will ask patients about discomfort or pain.
The responses will be recorded, and the maximum pain score noted.
Colonoscopists not participating in gathering the informations.
|
1 hour.
|
|
Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy.
時間枠：6 hours.
|
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
6 hours.
|
|
Number of flatus episodes post-procedure.
時間枠：24 hours.
|
Recorded at discharge and assessed post-procedure up to 24 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
24 hours.
|
|
Number of incontinence episodes post-procedure.
時間枠：6 hours.
|
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
6 hours.
|
|
Toilet use for bowel movement post-procedure.
時間枠：6 hours.
|
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
6 hours.
|
|
Patients' satisfaction with the procedure.
時間枠：24 hours.
|
Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not satisfied, 10=very satisfied).
Results will be recorded by telephone recall.
|
24 hours.
|
|
Willingness to repeat colonoscopy.
時間枠：24 hours.
|
Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not willing to repeat, 10=very likely to repeat).
Results will be recorded by telephone recall.
|
24 hours.
|
|
Interference of colonoscopy on work/normal activities the same day of the procedure.
時間枠：Up to 12 hours.
|
Assessed post-procedure after 12 hours using a questionnaire given to patients (0=nothing at all, 10=a lot).
Results will be recorded by telephone recall.
|
Up to 12 hours.
|
|
Day of work missed the day after the procedure.
時間枠：24 hours.
|
Work activities missed the day after colonoscopy due to some effect of the procedure (yes, no).
Assessed post-procedure after 24 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
24 hours.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cecal intubation rate.
時間枠：1 hour.
|
Cecal intubation will be defined as reaching beyond the ileocecal valve with adequate visualization of the appendix orifice.
|
1 hour.
|
|
Cecal intubation time.
時間枠：1 hour.
|
Defined as the time for passage of the colonoscope from the rectum to the cecum.
|
1 hour.
|
|
Total procedure time.
時間枠：1 hour.
|
Total procedure time (including time required for water infusion, polyp resection or biopsy).
|
1 hour.
|
|
Adenoma detection rate.
時間枠：9 months.
|
Proportion of subjects with at least one adenoma of any size.
|
9 months.
|
|
On-demand sedation.
時間枠：1 hour.
|
Offered at patient request for a NRS score ≥2.
Medications given as per institutional regulation.
Dose titrated based on patients' reported real-time pain score, age, weight and comorbidity.
|
1 hour.
|
|
Oxygen desaturation.
時間枠：1 hour.
|
Significant oxygen desaturation (<85% for >15 seconds) will be recorded.
|
1 hour.
|
|
Vagal reaction.
時間枠：1 hour.
|
Vagal reaction (heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting) will be recorded.
|
1 hour.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Sergio Cadoni, MD、S. Barbara Hospital, Iglesias (CI) Italy
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4. doi: 10.1016/s0016-5107(02)70176-4.
- Zubarik R, Fleischer DE, Mastropietro C, Lopez J, Carroll J, Benjamin S, Eisen G. Prospective analysis of complications 30 days after outpatient colonoscopy. Gastrointest Endosc. 1999 Sep;50(3):322-8. doi: 10.1053/ge.1999.v50.97111.
- de Jonge V, Sint Nicolaas J, van Baalen O, Brouwer JT, Stolk MF, Tang TJ, van Tilburg AJ, van Leerdam ME, Kuipers EJ; SCoPE consortium. The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. Am J Gastroenterol. 2012 Jun;107(6):878-84. doi: 10.1038/ajg.2012.40. Epub 2012 Mar 6.
- Lee YC, Wang HP, Chiu HM, Lin CP, Huang SP, Lai YP, Wu MS, Chen MF, Lin JT. Factors determining post-colonoscopy abdominal pain: prospective study of screening colonoscopy in 1000 subjects. J Gastroenterol Hepatol. 2006 Oct;21(10):1575-80. doi: 10.1111/j.1440-1746.2006.04145.x.
- Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.
- Cadoni S, Falt P, Gallittu P, Liggi M, Smajstrla V, Leung FW. Impact of carbon dioxide insufflation and water exchange on postcolonoscopy outcomes in patients receiving on-demand sedation: a randomized controlled trial. Gastrointest Endosc. 2017 Jan;85(1):210-218.e1. doi: 10.1016/j.gie.2016.05.021. Epub 2016 May 17.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年4月1日
一次修了 (実際)
2015年11月1日
研究の完了 (実際)
2015年11月1日
試験登録日
最初に提出
2015年3月23日
QC基準を満たした最初の提出物
2015年4月1日
最初の投稿 (見積もり)
2015年4月7日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年11月5日
QC基準を満たした最後の更新が送信されました
2015年11月4日
最終確認日
2015年10月1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。