Rectal AdenocarcinomaAuditCRNCT04349384
Audit of Surgery for Colorectal Cancer
An observational study of Rectal Adenocarcinoma and Colon Adenocarcinoma, run by Institut National d'Oncologie, Morocco at 1 site in Morocco.
Trial summary
The aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. This study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the National Institute of Oncology in Rabat during a two-years period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma, Colon Adenocarcinoma
- What is being tested?
- Colorectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 136 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Jan 2018to 31 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive adult patients (> 18 years) who underwent surgical resection for colon or rectal adenocarcinoma, with curative intent between 1 January 2018 and 31 December 2019, at the Digestive surgical oncology department of the National Institute of Oncology in Rabat Morocco.
Who may be able to join
- Patients with histologically proven colorectal adenocarcinoma who underwent surgical resection with curative intent between 1 January 2018 and 31 December 2019.
Who cannot join
- Colon or rectal resections for other histologic types than adenocarcinoma.
- Palliative intent surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Audit of the Quality of Surgical Treatment of Colorectal Cancer
The aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. This study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the National Institute of Oncology in Rabat during a two-years period. Using standardized forms, the investigators collected data relating to each stage of treatment: pre-therapeutic, surgical and post-operative in order to measure the quality of the surgical care delivered. These results were compared to established benchmarks and to similar audit studies carried out in other countries around the world.
Read the detailed description
Quality improvement initiatives and in particular the accreditation procedure raises the inevitable question of measuring quality in health. Several surgical audits have been carried out internationally, showing the importance of collecting reliable and valid information on the quality of care. This approach allows an evaluation and improvement of the quality of care provided, significantly correlated to a direct impact on morbidity and mortality. In addition, it provides valuable information for evidence-based medicine research as it provides data on patients often excluded from therapeutic trials.
Colorectal cancer is the first digestive cancer and the third cancer worldwide. Surgical resection is the main curative treatment. Surgical quality is associated with better short and long term results. Quality improvement measures, with the goal to improve surgical care of colorectal cancer, are becoming a standard worldwide.
The aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. This study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the National Institute of Oncology in Rabat. Using standardized forms, the investigators collected data relating to each stage of treatment: pre-therapeutic, surgical and post-operative in order to measure the quality of the surgical care delivered. These results were compared to established benchmarks and to similar audit studies carried out in other countries around the world.
- Conditions
- Rectal Adenocarcinoma, Colon Adenocarcinoma
- Being tested
- Colorectal resection
- Keywords
- Rectal neoplasms, Colon neoplasms
- Medical subject headings
- Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal resectionProcedure or surgery
Colon or rectal resection for colorectal adenocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| Colon adenocarcinoma | Patient who underwent surgical resection for colon adenocarcinoma Receives: Procedure: Colorectal resection | |
| Rectal adenocarcinoma | Patient who underwent surgical resection for rectal adenocarcinoma Receives: Procedure: Colorectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrieved lymph nodes
Number patients with retrieved lymph nodes after colon resection above 12
Measured: 1 month after surgery
Positive circumferential margin
The rate of patients with circumferential margin < 1 mm on surgical specimen of rectal resection for rectal adenocarcinoma.
Measured: 1 month after surgery
Morbidity
Morbidity assessed using using the Clavien-Dindo grading system at discharge and at 90 days after surgical resection for colorectal adenocarcinoma
Measured: 90 days after surgery
Secondary outcomes (5)
Pre-operative CT-scan
Rate of patients who had computed tomography before surgery
Measured: 7 days after surgery
Multidisciplinary team meeting
Rate of cases who were discussed during a multidisciplinary team meeting before surgery for patients who had surgical resection for colorectal adenocarcinoma
Measured: 7 days after surgery
MRI for rectal adenocarcinoma
Rate pf patients who had a pelvic Magnetic resonance imaging or rectal ultra-sonography in the pre-operative work-up of rectal adenocarcinoma
Measured: 7 days after surgery
Anastomotic leakage
Rate of anastomotic leakage after resection of colorectal cancer with the creation of anastomosis
Measured: 90 days after surgery
Readmission
Rate of hospital readmissions leakage after resection of colorectal cancer
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies 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
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National d'Oncologie, Morocco
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anass Majbar, Institut National d'Oncologie, Morocco
- Investigators
- Anass M Majbar, Principal investigator, National Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349384
- Sponsor's protocol ID
- SCOD 2
- Acronym
- AuditCR
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Under reasonable request, we would share individual patient data
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audit of the Quality of Surgical Treatment of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04349384
- Acronym / sponsor ID
- AuditCR / SCOD 2
- Conditions
- Rectal Adenocarcinoma, Colon Adenocarcinoma
- Keywords
- Rectal neoplasms, Colon neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Institut National d'Oncologie, MoroccoOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Apr 2020 (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.
The aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. This study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the National Institute of Oncology in Rabat during a two-years period. Using standardized forms, the investigators collected data relating to each stage of treatment: pre-therapeutic, surgical and post-operative in order to measure the quality of the surgical care delivered. These results were compared to established benchmarks and to similar audit studies carried out in other countries around the world.
Detailed description
Quality improvement initiatives and in particular the accreditation procedure raises the inevitable question of measuring quality in health. Several surgical audits have been carried out internationally, showing the importance of collecting reliable and valid information on the quality of care. This approach allows an evaluation and improvement of the quality of care provided, significantly correlated to a direct impact on morbidity and mortality. In addition, it provides valuable information for evidence-based medicine research as it provides data on patients often excluded from therapeutic trials.
Colorectal cancer is the first digestive cancer and the third cancer worldwide. Surgical resection is the main curative treatment. Surgical quality is associated with better short and long term results. Quality improvement measures, with the goal to improve surgical care of colorectal cancer, are becoming a standard worldwide.
The aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. This study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the National Institute of Oncology in Rabat. Using standardized forms, the investigators collected data relating to each stage of treatment: pre-therapeutic, surgical and post-operative in order to measure the quality of the surgical care delivered. These results were compared to established benchmarks and to similar audit studies carried out in other countries around the world.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colon adenocarcinoma | – | Procedure: Colorectal resectionPatient who underwent surgical resection for colon adenocarcinoma |
| Rectal adenocarcinoma | – | Procedure: Colorectal resectionPatient who underwent surgical resection for rectal adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients (> 18 years) who underwent surgical resection for colon or rectal adenocarcinoma, with curative intent between 1 January 2018 and 31 December 2019, at the Digestive surgical oncology department of the National Institute of Oncology in Rabat Morocco.
Key inclusion criteria (1 listed)
- Patients with histologically proven colorectal adenocarcinoma who underwent surgical resection with curative intent between 1 January 2018 and 31 December 2019.
Key exclusion criteria (2 listed)
- Colon or rectal resections for other histologic types than adenocarcinoma.
- Palliative intent surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal resectionColon or rectal resection for colorectal adenocarcinoma | Procedure or surgery | Colon adenocarcinoma, Rectal adenocarcinoma |
Primary outcome
Retrieved lymph nodes
Time frame: 1 month after surgery
Number patients with retrieved lymph nodes after colon resection above 12
Positive circumferential margin
Time frame: 1 month after surgery
The rate of patients with circumferential margin < 1 mm on surgical specimen of rectal resection for rectal adenocarcinoma.
Morbidity
Time frame: 90 days after surgery
Morbidity assessed using using the Clavien-Dindo grading system at discharge and at 90 days after surgical resection for colorectal adenocarcinoma
5 secondary outcomes
Pre-operative CT-scan
Time frame: 7 days after surgery
Multidisciplinary team meeting
Time frame: 7 days after surgery
MRI for rectal adenocarcinoma
Time frame: 7 days after surgery
Anastomotic leakage
Time frame: 90 days after surgery
Readmission
Time frame: 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Individual participant dataSharing planned: Undecided. Under reasonable request, we would share individual patient data
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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.
Anass M Majbar principal investigator
National Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Adenocarcinoma and Colon Adenocarcinoma, run by Institut National d'Oncologie, Morocco at 1 site 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retrieved lymph nodes (time frame: 1 month after surgery). The study lists 3 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 16 Apr 2020.