Digestive System NeoplasmsObchirNCT03681600
Observatory of the Quality of Surgical Procedures for Digestive Cancers
An observational study of Digestive System Neoplasms and Surgery, run by Moroccan Society of Surgery at 4 sites in Morocco.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Digestive System Neoplasms, Surgery, Surgery--Complications
- How many people
- 1,043 participants
- Where
- 4 sitesMorocco
- Study dates
- 1 Jan 2018to 30 Jun 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated for digestive cancer from 1st January 2018 to December 2020 in 4 moroccan surgical departments
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Morocco4 sites
Regional center of oncology, surgical department
Oujda
National Institut of Oncology, Surgical oncology department
Rabat, Please Enter the State Or Province, 10100
Ibn Sina Hospital, Surgical department A
Rabat, 10100
Ibn Sina Hospital, Surgical department C
Rabat, 10100
About this study
Official title: Observatory of the Quality of Surgical Procedures for Digestive Cancers: Pilot Project.
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.
Read more
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
- Medical subject headings
- Digestive System Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Mortality rate
Death within 90 days of surgical procedure
Measured: 90 days from surgery
90-day Complication rate
Defined with by Clavien-Dindo grade I to IV within90 days of surgical procedure
Measured: 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
Measured: 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
Measured: 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
For every localization
Measured: Prior to surgery
Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging
For every localization
Measured: Prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Jan 2018
- Primary completion31 Mar 2020
- Study completion30 Jun 2020
Why it stopped: COVID 19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,043 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Moroccan Society of Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche sur le Cancer, 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
- Responsible party
- Sponsor
- Investigators
- Amine Benkabbou, Pr, Study director, Moroccan Society of SurgeryRaouf Mohsine, Pr, Principal investigator, National institut of oncologyAbdelmalek Hrora, Pr, Principal investigator, Moroccan Society of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681600
- Sponsor's protocol ID
- MoroccanSS
- Acronym
- Obchir
- Status last verified
- Sep 2021
- First submitted
- 28 Mar 2018
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of the Quality of Surgical Procedures for Digestive Cancers: Pilot Project.
- ClinicalTrials.gov ID
- NCT03681600
- Acronym / sponsor ID
- Obchir / MoroccanSS
- Conditions
- Digestive System Neoplasms, Surgery, Surgery--Complications, Quality of Health Care, Medical Audit
- Keywords
- audit, cancer, guidelines, ouctomes, survival, digestive cancer surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID 19
- Enrolment
- 1,043 participants (actual)
- Lead sponsor
- Moroccan Society of SurgeryUniversity, hospital or other
- Collaborators
- Institut de Recherche sur le Cancer, 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
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated for digestive cancer from 1st January 2018 to December 2020 in 4 moroccan surgical departments
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Patient whose surgical intervention is indicated for:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
90-day Mortality rate
Time frame: 90 days from surgery
Death within 90 days of surgical procedure
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-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
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
2 secondary outcomes
Treatment decisions made within multidisciplinary team meeting / tumour board
Time frame: Prior to surgery
Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging
Time frame: Prior to surgery
Results and safety
The study was stopped early (reason given: COVID 19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Website of the projectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amine Benkabbou, Pr study director
Moroccan Society of Surgery
Raouf Mohsine, Pr principal investigator
National institut of oncology
Abdelmalek Hrora, Pr principal investigator
Moroccan Society of Surgery
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive System Neoplasms and Surgery, run by Moroccan Society of Surgery at 4 sites in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID 19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day Mortality rate (time frame: 90 days from surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.