Observatory of the Quality of Surgical Procedures for Digestive Cancers (Obchir)
Observatory of the Quality of Surgical Procedures for Digestive Cancers: Pilot Project.
Surgery for digestive cancers is managed according to quality standards, validated by the scientific community. Despite the diffusion of these standards through the benchmarks of good practice, the results of the surgery remain disparate.
In many countries, this "inequality of opportunity" has justified the establishment of quality assurance systems to measure the results of surgery for one or more localizations of digestive cancer.
These surgical audit experiments have shown a positive, rapid and cost-effective impact on complication rates, recurrence rates and overall survival even in the absence of interventional measures. The data collected also helped to improve the management of subgroups of patients usually excluded from clinical trials.
In Morocco, the National Cancer Prevention and Control Plan provides for the establishment of a quality assurance system with the introduction of a system for monitoring and evaluating the care of patients. This pilot project is part of this framework, for the group of patients who are candidates for surgery for digestive cancers.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Oujda、モロッコ
- Regional center of oncology, surgical department
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Rabat、モロッコ、10100
- Ibn Sina Hospital, Surgical department A
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Rabat、モロッコ、10100
- Ibn Sina Hospital, Surgical department C
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Please Enter The State Or Province
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Rabat、Please Enter The State Or Province、モロッコ、10100
- National Institut of Oncology, Surgical oncology department
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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:
- patients operated for a digestive cancer, proven or suspected, in a curative or palliative intent In elective situation: inclusion from surgery programming In emergent situation: inclusion no later than 72 hours after surgery
- Cancer proven or suspected in the following digestive tract: colon, appendix, anus, rectum, esophagus, stomach, eso-gastric junction, bile ducts, ampulla of Vater , pancreas, duodenum, small intestine and liver.
- Patient willing and able to agree to participate in the study
Exclusion Criteria:
Patient whose surgical intervention is indicated for:
- a condition that is not a digestive tract cancer, including whether retrospectively surgical exploration and / or histological examination reveals digestive localization cancer
- proven or suspected cancer of non-digestive location
- a proven or suspected cancer of peritoneal localization
- Patient whose surgical intervention is indicated for a progressive disease or a local recurrence proven or suspected of a digestive localization cancer having already been the resected (with the exception of situations of iterative liver resection for liver metastasis hepatic and recovery of the tumor bed after the discovery of vesicular cancer on cholecystectomy specimen)
- Patients whose intervention is for diagnostic purposes without any curative or palliative intention
- Patients whose surgery is a liver transplant
- Patients whose surgical intervention is local destruction (radiofrequency, microwaves) exclusively by percutaneous approach (without laparotomy or laparoscopy)
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
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 |
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90-day Mortality rate
時間枠：90 days from surgery
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Death within 90 days of surgical procedure
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90 days from surgery
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90-day Complication rate
時間枠：90 days from surgery
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Defined with by Clavien-Dindo grade I to IV within90 days of surgical procedure
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90 days from surgery
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3-year Overall survival
時間枠：from the date of operation to date of death from any cause, whichever came first, assessed up to 3 year
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Overall survival is defined as time from initiation to death of any cause within 3years of surgical procedure
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from the date of operation to date of death from any cause, whichever came first, assessed up to 3 year
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3-year disease free survival
時間枠：from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 3 years
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Disease free survival is defined as time from initiation to death of any cause within 3years of surgical procedure
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from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 3 years
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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 |
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Treatment decisions made within multidisciplinary team meeting / tumour board
時間枠：Prior to surgery
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For every localization
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Prior to surgery
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Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging
時間枠：Prior to surgery
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For every localization
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Prior to surgery
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協力者と研究者
協力者
捜査官
- スタディディレクター：Amine Benkabbou, Pr、Moroccan Society of Surgery
- 主任研究者：Raouf Mohsine, Pr、National institut of oncology
- 主任研究者：Abdelmalek Hrora, Pr、Moroccan Society of Surgery
出版物と役立つリンク
便利なリンク
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 (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。