Audit of Surgery for Colorectal Cancer (AuditCR)

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.

Study Overview

• Status: Completed
• Conditions: Rectal Adenocarcinoma; Colon Adenocarcinoma
• Intervention / Treatment: Procedure: Colorectal resection

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 Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• Morocco
  • Rabat, Morocco, 10100
    • Institut National D'Oncologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colon adenocarcinoma; Patient who underwent surgical resection for colon adenocarcinoma	Procedure: Colorectal resection; Colon or rectal resection for colorectal adenocarcinoma
Rectal adenocarcinoma; Patient who underwent surgical resection for rectal adenocarcinoma	Procedure: Colorectal resection; Colon or rectal resection for colorectal adenocarcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrieved lymph nodes	Number patients with retrieved lymph nodes after colon resection above 12	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.	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	90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative CT-scan	Rate of patients who had computed tomography before surgery	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	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	7 days after surgery
Anastomotic leakage	Rate of anastomotic leakage after resection of colorectal cancer with the creation of anastomosis	90 days after surgery
Readmission	Rate of hospital readmissions leakage after resection of colorectal cancer	90 days after surgery

Collaborators and Investigators

• Sponsor: Institut National d'Oncologie, Morocco
• Investigators: Principal Investigator: Anass M Majbar, National Institute of Oncology

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Rectal neoplasms; Colon neoplasms
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: SCOD 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Under reasonable request, we would share individual patient data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No