Factors Related to a Persistent Inadequate Bowel Preparation for Colonoscopy (REPREP)
Factors Related to a Persistent Inadequate Bowel Preparation After a Colonoscopy With Inadequate Colon Cleansing. An Observational Prospective Multicenter Study
Adequate bowel preparation for colonoscopy has an extremely relevant impact on diagnostic yield and procedural success. The guidelines recommend an adequate colon cleansing rate of at least 90% of procedures. It has been shown that patients with inadequate colon cleansing history have a high probability of not reaching an adequate bowel preparation again.
Surprisingly, no evidence-based recommendations are available regarding bowel preparation in the patient with inadequate colon cleansing history. Therefore, identifying the factors associated with repeated inadequacy of bowel cleansing is crucial in order to define the best preparation strategy in this subset of patients. The implications for patients and for healthcare system are many: improving the quality of bowel preparation would reduce the need to repeat colonoscopy and the risk of conducting unreliable examinations. Furthermore, it would reduce the costs for the healthcare system by avoiding to overload endoscopic units.
Inclusion criteria:
Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing.
Exclusion criteria:
- Emergency regime
- Inability to obtain consent
- Refusal of the patient
Primary end-point:
Identification of factors independently associated with repeated inadequate colon cleansing after inadequate bowel preparation at previous colonoscopy, and consequent development (and validation) of a predictive model.
The colon cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigns a score from 0 (presence of solid stools) to 3 (excellent visualization of the colonic mucosa) for each of the three main segments of the colon, i.e. right colon, transverse colon and left-rectum colon. Colon cleansing will be judged inadequate in case of a total score <6 or a score <2 even in only one of the colic segments.
Secondary end-point:
• Assess the prevalence of repeated inadequate bowel cleansing in the patient with previous inadequate cleansing
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Lorenzo Fuccio, MD
- 電話番号:+39 3383079255
- メール:lorenzofuccio@gmail.com
研究場所
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BO
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Bologna、BO、イタリア、40138
- 募集
- UOC Gastroenterologia ed Endoscopia Digestiva
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コンタクト:
- Lorenzo Fuccio, MD
- 電話番号:+39 3383079255
- メール:lorenzofuccio@gmail.com
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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
説明
Inclusion Criteria:
- Outpatients or hospitalized patients
- adults
- candidates for colonoscopy for any pathology, in the normal pathway of care, with the need to repeat the bowel preparation due to inadequate colon cleansing.
Exclusion Criteria:
- Emergency regimen
- Inability to obtain consent
- Patient refusal
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 |
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Study cohort
Inclusion criteria: Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing. Exclusion criteria:
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A colonoscopy scheduled within the normal pathway of care will be performed.
No interventions will be performed.
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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 |
---|---|---|
Identification of factors related to persistent inadequate colon cleansing at repeat colonoscopy due to inadequate colon cleansing.
時間枠:Outcome will be assessed during colonoscopy.
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A logistic regression analysis will be run to identify such factors.
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Outcome will be assessed during colonoscopy.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Prevalence of persistent inadequate colon cleansing at repeat colonoscopy due to inadequate colon cleansing.
時間枠:Outcome will be assessed during colonoscopy.
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The prevalence of inadequate colon cleansing at repeat colonoscopy will be assessed
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Outcome will be assessed during colonoscopy.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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。
結腸疾患の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ