Observatory of the Quality of Surgical Procedures for Digestive Cancers

Study Overview
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Brief Summary
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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.

Official Title
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Observatory of the Quality of Surgical Procedures for Digestive Cancers: Pilot Project.

Conditions
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Digestive System Neoplasms, Surgery, Surgery--Complications, Quality of Health Care, Medical Audit

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day Mortality rate | Death within 90 days of surgical procedure | 90 days from surgery | 
| 90-day Complication rate | Defined with by Clavien-Dindo grade I to IV within90 days of surgical procedure | 90 days from surgery | 
| 3-year Overall survival | Overall survival is defined as time from initiation to death of any cause within 3years of surgical procedure | from the date of operation to date of death from any cause, whichever came first, assessed up to 3 year | 
| 3-year disease free survival | Disease free survival is defined as time from initiation to death of any cause within 3years of surgical procedure | from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment decisions made within multidisciplinary team meeting / tumour board | For every localization | Prior to surgery | 
| Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging | For every localization | Prior to surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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audit, cancer, guidelines, ouctomes, survival, digestive cancer surgery