Clinical trial NCT04349384: Audit of Surgery for Colorectal Cancer
Official title: Audit of the Quality of Surgical Treatment of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Adenocarcinoma
Colon Adenocarcinoma
Keywords: Rectal neoplasms
Colon neoplasms
Lead sponsor: Institut National d'Oncologie, Morocco
Sponsor class: OTHER_GOV
First posted: 2020-04-16
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven colorectal adenocarcinoma who underwent surgical resection with curative intent between 1 January 2018 and 31 December 2019.

Exclusion Criteria:

* Colon or rectal resections for other histologic types than adenocarcinoma.
* Palliative intent surgery.

Primary outcomes:
measure: Retrieved lymph nodes
timeFrame: 1 month after surgery
measure: Positive circumferential margin
timeFrame: 1 month after surgery
measure: Morbidity
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Pre-operative CT-scan
timeFrame: 7 days after surgery
measure: Multidisciplinary team meeting
timeFrame: 7 days after surgery
measure: MRI for rectal adenocarcinoma
timeFrame: 7 days after surgery
measure: Anastomotic leakage
timeFrame: 90 days after surgery
measure: Readmission
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: Institut National d'Oncologie
Study officials:
affiliation: National Institute of Oncology
name: Anass M Majbar
role: PRINCIPAL_INVESTIGATOR
References: