Observatory of the Quality of Surgical Procedures for Digestive Cancers

NCT03681600 | Terminated DMC

• 1 other identifier: MoroccanSS
• Study Type: observational
• Target: 1,043
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

audit; cancer; guidelines; ouctomes; survival; digestive cancer surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (4)

National Institut of Oncology, Surgical oncology department

Rabat, Please Enter the State Or Province, 10100, Morocco

Location

Regional center of oncology, surgical department

Oujda, Morocco

Location

Ibn Sina Hospital, Surgical department A

Rabat, 10100, Morocco

Location

Ibn Sina Hospital, Surgical department C

Rabat, 10100, Morocco

Location

Related Links

• Website of the project

MeSH Terms

Conditions

Digestive System Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Digestive System Diseases

Study Officials

• Amine Benkabbou, Pr

  Moroccan Society of Surgery

  STUDY DIRECTOR

• Raouf Mohsine, Pr

  National institut of oncology

  PRINCIPAL INVESTIGATOR

• Abdelmalek Hrora, Pr

  Moroccan Society of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: September 24, 2018
• Study Start: January 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: June 30, 2020
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

MO (4)