Clinical trial NCT03681600: Observatory of the Quality of Surgical Procedures for Digestive Cancers
Official title: Observatory of the Quality of Surgical Procedures for Digestive Cancers: Pilot Project.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Digestive System Neoplasms
Surgery
Surgery--Complications
Quality of Health Care
Medical Audit
Keywords: audit
cancer
guidelines
ouctomes
survival
digestive cancer surgery
Lead sponsor: Moroccan Society of Surgery
Sponsor class: OTHER
Collaborators: name: Institut de Recherche sur le Cancer
name: L'Ecole nationale supérieure d'informatique et d'analyse des systèmes (ENSIAS)(Mohammed V university in Rabat)
name: Faculté des sciences de Rabat (Mohammed V university in Rabat)
name: Stratance Consulting
First posted: 2018-09-24
Enrollment: 1043
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated for digestive cancer from 1st January 2018 to December 2020 in 4 moroccan surgical departments

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 90-day Mortality rate
timeFrame: 90 days from surgery
measure: 90-day Complication rate
timeFrame: 90 days from surgery
measure: 3-year Overall survival
timeFrame: from the date of operation to date of death from any cause, whichever came first, assessed up to 3 year
measure: 3-year disease free survival
timeFrame: from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 3 years
Secondary outcomes:
measure: Treatment decisions made within multidisciplinary team meeting / tumour board
timeFrame: Prior to surgery
measure: Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging
timeFrame: Prior to surgery
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: National Institut of Oncology, Surgical oncology department
state: Please Enter The State Or Province
city: Oujda
country: Morocco
facility: Regional center of oncology, surgical department
city: Rabat
country: Morocco
facility: Ibn Sina Hospital, Surgical department A
city: Rabat
country: Morocco
facility: Ibn Sina Hospital, Surgical department C
Study officials:
affiliation: Moroccan Society of Surgery
name: Amine Benkabbou, Pr
role: STUDY_DIRECTOR
affiliation: National institut of oncology
name: Raouf Mohsine, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Moroccan Society of Surgery
name: Abdelmalek Hrora, Pr
role: PRINCIPAL_INVESTIGATOR
References: