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Observatory of the Quality of Surgical Procedures for Digestive Cancers (Obchir)

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ClinicalTrials.gov Identifier: NCT03681600
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Collaborators:
Institut de Recherche sur le Cancer (IRC)
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
Information provided by (Responsible Party):
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.


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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Observatory of the Quality of Surgical Procedures for Digestive Cancers: Pilot Project.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020



Primary Outcome Measures :
  1. 90-day Mortality rate [ Time Frame: 90 days from surgery ]
    Death within 90 days of surgical procedure

  2. 90-day Complication rate [ Time Frame: 90 days from surgery ]
    Defined with by Clavien-Dindo grade I to IV within90 days of surgical procedure

  3. 3-year Overall survival [ Time Frame: 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

  4. 3-year disease free survival [ Time Frame: 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 :
  1. Treatment decisions made within multidisciplinary team meeting / tumour board [ Time Frame: Prior to surgery ]
    For every localization

  2. Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging [ Time Frame: Prior to surgery ]
    For every localization



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients operated for digestive cancer from 1st January 2018 to December 2020 in 4 moroccan surgical departments
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681600


Contacts
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Contact: Amine Souadka, Pr +212 666953668 a.souadka@um5s.net.ma
Contact: Anass Majbar, Pr +212 668846573 anass.majbar@um5s.net.ma

Locations
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Morocco
National Institut of Oncology, Surgical oncology department Recruiting
Rabat, Please Enter The State Or Province, Morocco, 10100
Contact: Amine Souadka, Pr    666953668    a.souadka@um5s.net.ma   
Contact: Amine Benkabbou, Pr       a.benkabbou@um5s.net.ma   
Principal Investigator: Raouf Mohsine, Pr         
Regional center of oncology, surgical department Recruiting
Oujda, Morocco
Contact: El Harroudi Tijani, Pr       el.harroudi@hotmail.com   
Contact: Serji Badr, Pr       badr.serji@hotmail.fr   
Principal Investigator: Tijani El Harroudi, Pr         
Ibn Sina Hospital, Surgical department A Recruiting
Rabat, Morocco, 10100
Contact: Abdelkader Belkouchi, Pr       belkouchiabdelkader@yahoo.fr   
Contact: Amine Benkabbou, Pr       a.benkabbou@um5s.net.ma   
Principal Investigator: Abdelkader Belkouchi         
Ibn Sina Hospital, Surgical department C Recruiting
Rabat, Morocco, 10100
Contact: Mohammed Ahallat, Pr       ahallat@gmail.com   
Contact: Abdelmalek Hrora, Pr       hroramalek@gmail.com   
Principal Investigator: Mohammed Ahallat, Pr         
Sponsors and Collaborators
Moroccan Society of Surgery
Institut de Recherche sur le Cancer (IRC)
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
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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

Additional Information:
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Responsible Party: Moroccan Society of Surgery
ClinicalTrials.gov Identifier: NCT03681600     History of Changes
Other Study ID Numbers: MoroccanSS
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Moroccan Society of Surgery:
audit
cancer
guidelines
ouctomes
survival
digestive cancer surgery
Additional relevant MeSH terms:
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Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases