Perioperative Use of a Selective COX2 Inhibitor in Patients Undergoing Elective Colorectal Surgery: the Effect on Post-operative Bowel Motility and Post-operative Pain
調査の概要
詳細な説明
Post-operative ileus is a common surgical complication occurring in with up to 20% of patients, with a significant clinical and economical effect.
Many preventative measures have been tested to promote gastrointestinal motility following intestinal surgery have been suggested.
The medical intervention in the proposed study includes administration of a selective COX-2 inhibitor, specifically Celecoxib, in the peri-operative period following an elective colon resection. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic therapeutic effects.
The drug is approved for use in by the ministry of health in Israel and in the United states. The study aims to assess the use of this widely used medication for evaluation of the clinical effect on post-operative bowel transit, as well as the drugs' effect on post-operative pain.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
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:
- Patients between the age of 18 and 80
- Patients planned for elective colorectal surgery with primary anastomosis
- ASA score of 1-3
- Patients that are able to sign an informed consent and comply with the protocol
Exclusion Criteria:
- Patients with inflammatory bowel disease
- Patients that require emergency surgery
- Patients with renal failure, measured by Creatinine level > 1.5 mg/dL (>106.1 micro mol/l)
- Patients with significant liver failure (known cirrhosis, Bilirubin level>2 mg/dL or 34.2 µmol/L)
- Patients with known allergy to any medication from the non-steroidal anti-inflammatory drug group.
- Patients treated chronically with any type of COX inhibitor.
- Patients treated with NSAIDS including Aspirin 7 days prior to the date of surgery.
- Patients with active peptic disease
- Patient expected to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics or neuroleptics in the postoperative period
- Patient with dysphagia or that have a difficulty swallowing capsules or tablets, or is unable to tolerate oral medication
- Pregnant / lactating women.
- Patients participating in any other interventional clinical trial
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：防止
- 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 |
|---|---|
|
実験的：Celecoxib
Celecoxib will be given orally to patients participating in the study and allocated to the treatment group, for an intervention period of 6 days, starting from the day of surgery. Celecoxib will be given throughout the intervention period of the study orally at a dose of 400 mg per day divided into two doses, a dose which is within the recommended and a widely used dosage and is expected to induce a significant inhibition of prostaglandin synthesis by the COX2 pathway. Celecoxib will be given throughout the intervention period of the study orally at a dose of 400 mg per day divided into two doses. |
NSAIDS
|
|
プラセボコンパレーター：Placebo
Placebo will be given orally to patients participating in the study and allocated to the control group that will receive placebo, for an intervention period of 6 days, starting from the day of surgery. Placebo will be given throughout the intervention period of the study orally in capsules that resemble the drug, twice a day. |
プラセボ
|
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 |
|---|---|---|
|
First flatus/bowel movement (questionnaire)
時間枠：48 to 72 hours after surgery
|
Reduction of time for first flatus/bowel movement from 48 hours to 72 hours in average following surgery.
|
48 to 72 hours after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reduction of post operative ileus (questionnaire)
時間枠：First week after surgery
|
Reduction of post-operative ileus rate in patients following colorectal surgery, treated with Celecoxib when compared with patients treated with placebo.
|
First week after surgery
|
|
Post operative pain reduction (VAS score)
時間枠：First week after surgery
|
Post-operative pain reduction quality in patients treated with Celecoxib when compared with patients treated with placebo following surgery.
|
First week after surgery
|
|
Reduction of opoids consumption (registration of all medications)
時間枠：First month after surgery
|
Reduction the amount of opioids consumed in patients treated with Celecoxib when compared with patients treated with placebo following surgery.
|
First month after surgery
|
|
Post operative complication rate (patients follow up)
時間枠：First month after surgery
|
Post-operative complication rate, more specifically the rate of anastomotic leakage in patients treated with Celecoxib compared with patients treated with placebo.
|
First month after surgery
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (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 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2913-16-SMC
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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