Observatory of the Quality of Surgical Procedures for Digestive Cancers

Surgery Clinical Trial

— Obchir  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03681600
• Other study ID #: MoroccanSS
• Status: Terminated
• Start date: January 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2021
• Source: Moroccan Society of Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1043
• Est. completion date: June 30, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Locations

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

Sponsors (5)

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

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day Mortality rate	Death within 90 days of surgical procedure	90 days from surgery
Primary	90-day Complication rate	Defined with by Clavien-Dindo grade I to IV within90 days of surgical procedure	90 days from surgery
Primary	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
Primary	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	Treatment decisions made within multidisciplinary team meeting / tumour board	For every localization	Prior to surgery
Secondary	Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging	For every localization	Prior to surgery

External Links

•   Website of the project