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Completed

NCT Number: NCT04349384

Audit of Surgery for 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.

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Key information

Conditions

Rectal Adenocarcinoma Colon Adenocarcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut National d'Oncologie

Rabat, 10100, Morocco

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

colorectal resection

Procedure

Colon or rectal resection for colorectal adenocarcinoma

Primary outcomes

  1. Retrieved lymph nodes

    Time frame: 1 month after surgery

    Number patients with retrieved lymph nodes after colon resection above 12

  2. 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.

  3. 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

Secondary outcomes

  1. Pre-operative CT-scan

    Time frame: 7 days after surgery

    Rate of patients who had computed tomography before surgery

  2. Multidisciplinary team meeting

    Time frame: 7 days after surgery

    Rate of cases who were discussed during a multidisciplinary team meeting before surgery for patients who had surgical resection for colorectal adenocarcinoma

  3. MRI for rectal adenocarcinoma

    Time frame: 7 days after surgery

    Rate pf patients who had a pelvic Magnetic resonance imaging or rectal ultra-sonography in the pre-operative work-up of rectal adenocarcinoma

  4. Anastomotic leakage

    Time frame: 90 days after surgery

    Rate of anastomotic leakage after resection of colorectal cancer with the creation of anastomosis

  5. Readmission

    Time frame: 90 days after surgery

    Rate of hospital readmissions leakage after resection of colorectal cancer

Sponsors and collaborators

Lead sponsor

Institut National d'Oncologie, Morocco

Other Gov

Registry information

Official study title

Audit of the Quality of Surgical Treatment of Colorectal Cancer

Acronym: AuditCR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2020
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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