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.

Study Overview

• Status: Terminated
• Conditions: Digestive System Neoplasms; Surgery; Surgery--Complications; Quality of Health Care; Medical Audit

• Study Type: Observational
• Enrollment (Actual): 1043

Contacts and Locations

Study Locations

• Morocco
  • Oujda, Morocco
    • Regional center of oncology, surgical department
  • Rabat, Morocco, 10100
    • Ibn Sina Hospital, Surgical department A
  • Rabat, Morocco, 10100
    • Ibn Sina Hospital, Surgical department C
  • Please Enter The State Or Province
    • Rabat, Please Enter The State Or Province, Morocco, 10100
      • National Institut of Oncology, Surgical oncology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients operated for digestive cancer from 1st January 2018 to December 2020 in 4 moroccan surgical departments

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Moroccan Society of Surgery
• Collaborators: 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
• Investigators: Study Director: Amine Benkabbou, Pr, Moroccan Society of Surgery; Principal Investigator: Raouf Mohsine, Pr, National institut of oncology; Principal Investigator: Abdelmalek Hrora, Pr, Moroccan Society of Surgery

Publications and helpful links

Helpful Links

• Website of the project

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: cancer; guidelines; survival; audit; digestive cancer surgery; ouctomes
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: MoroccanSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No