Audit of Surgery for Colorectal Cancer

Rectal Adenocarcinoma Clinical Trial

— AuditCR  

Official title:

Audit of the Quality of Surgical Treatment of Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349384
• Other study ID #: SCOD 2
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: Institut National d'Oncologie, Morocco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Colon Adenocarcinoma
• Rectal Adenocarcinoma

Intervention

Procedure:
• Colorectal resection
Colon or rectal resection for colorectal adenocarcinoma

Locations

Country	Name	City	State
Morocco	Institut National d'Oncologie	Rabat

Sponsors (1)

Lead Sponsor	Collaborator
Institut National d'Oncologie, Morocco

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrieved lymph nodes	Number patients with retrieved lymph nodes after colon resection above 12	1 month after surgery
Primary	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
Primary	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	Pre-operative CT-scan	Rate of patients who had computed tomography before surgery	7 days after surgery
Secondary	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
Secondary	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
Secondary	Anastomotic leakage	Rate of anastomotic leakage after resection of colorectal cancer with the creation of anastomosis	90 days after surgery
Secondary	Readmission	Rate of hospital readmissions leakage after resection of colorectal cancer	90 days after surgery