Observatory of the Quality of Surgical Procedures for Digestive Cancers

NCT ID: NCT03681600

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

1043 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut de Recherche sur le Cancer

OTHER_GOV

Sponsor Role collaborator

L'Ecole nationale supérieure d'informatique et d'analyse des systèmes (ENSIAS)(Mohammed V university in Rabat)

UNKNOWN

Sponsor Role collaborator

Faculté des sciences de Rabat (Mohammed V university in Rabat)

UNKNOWN

Sponsor Role collaborator

Stratance Consulting

UNKNOWN

Sponsor Role collaborator

Moroccan Society of Surgery

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amine Benkabbou, Pr

Role: STUDY_DIRECTOR

Moroccan Society of Surgery

Raouf Mohsine, Pr

Role: PRINCIPAL_INVESTIGATOR

National institut of oncology

Abdelmalek Hrora, Pr

Role: PRINCIPAL_INVESTIGATOR

Moroccan Society of Surgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institut of Oncology, Surgical oncology department

Rabat, Please Enter the State Or Province, Morocco

Site Status

Regional center of oncology, surgical department

Oujda, , Morocco

Site Status

Ibn Sina Hospital, Surgical department A

Rabat, , Morocco

Site Status

Ibn Sina Hospital, Surgical department C

Rabat, , Morocco

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Morocco

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MoroccanSS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CPET in Colorectal Surgery
NCT02298907 COMPLETED