Observatory of the Quality of Surgical Procedures for Digestive Cancers

Terminated

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

• Registration Number: NCT03681600
• Lead Sponsor: Moroccan Society of Surgery

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-28
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Primary Completion: 2020-03-31
• Study Completion: 2020-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1043

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

National Institut of Oncology, Surgical oncology department; 🇲🇦 Rabat, Please Enter The State Or Province, Morocco

Ibn Sina Hospital, Surgical department A; 🇲🇦 Rabat, Morocco

Ibn Sina Hospital, Surgical department C; 🇲🇦 Rabat, Morocco

Regional center of oncology, surgical department; 🇲🇦 Oujda, Morocco