Observatory of the Quality of Surgical Procedures for Digestive Cancers: Pilot Project.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1,043
- 试验地点
- 4
- 主要终点
- 90-day Mortality rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
90-day Mortality rate
时间窗: 90 days from surgery
Death within 90 days of surgical procedure
90-day Complication rate
时间窗: 90 days from surgery
Defined with by Clavien-Dindo grade I to IV within90 days of surgical procedure
3-year Overall survival
时间窗: from the date of operation to date of death from any cause, whichever came first, assessed up to 3 year
Overall survival is defined as time from initiation to death of any cause within 3years of surgical procedure
3-year disease free survival
时间窗: from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 3 years
Disease free survival is defined as time from initiation to death of any cause within 3years of surgical procedure
次要结局
- Treatment decisions made within multidisciplinary team meeting / tumour board(Prior to surgery)
- Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging(Prior to surgery)