Obchir: Observatory of the Quality of Surgical Procedures for Digestive Cancers

Sponsor

Moroccan Society of Surgery (Other)

Overall Status

Terminated

CT.gov ID

NCT03681600

Collaborator

Institut de Recherche sur le Cancer (Other), L'Ecole nationale supérieure d'informatique et d'analyse des systèmes (ENSIAS)(Mohammed V university in Rabat) (Other), Faculté des sciences de Rabat (Mohammed V university in Rabat) (Other), Stratance Consulting (Other)

1,043

Enrollment

Locations

29.9

Actual Duration (Months)

260.8

Patients Per Site

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Digestive System Neoplasms Surgery Surgery--Complications Quality of Health Care Medical Audit

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1043 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Jun 30, 2020

Outcome Measures

Primary Outcome Measures

90-day Mortality rate [90 days from surgery]
Death within 90 days of surgical procedure
90-day Complication rate [90 days from surgery]
Defined with by Clavien-Dindo grade I to IV within90 days of surgical procedure
3-year Overall survival [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 [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institut of Oncology, Surgical oncology department	Rabat	Please Enter The State Or Province	Morocco	10100
2	Regional center of oncology, surgical department	Oujda		Morocco
3	Ibn Sina Hospital, Surgical department A	Rabat		Morocco	10100
4	Ibn Sina Hospital, Surgical department C	Rabat		Morocco	10100

Sponsors and Collaborators

Moroccan Society of Surgery
Institut de Recherche sur le Cancer
L'Ecole nationale supérieure d'informatique et d'analyse des systèmes (ENSIAS)(Mohammed V university in Rabat)
Faculté des sciences de Rabat (Mohammed V university in Rabat)
Stratance Consulting