AuditCR: Audit of Surgery for Colorectal Cancer

Sponsor
Institut National d'Oncologie, Morocco (Other)
Overall Status
Completed
CT.gov ID
NCT04349384
Collaborator
(none)
136
1
24
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
136 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Audit of the Quality of Surgical Treatment of Colorectal Cancer
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Retrieved lymph nodes [1 month after surgery]

    Number patients with retrieved lymph nodes after colon resection above 12

  2. Positive circumferential margin [1 month after surgery]

    The rate of patients with circumferential margin < 1 mm on surgical specimen of rectal resection for rectal adenocarcinoma.

  3. Morbidity [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 Outcome Measures

  1. Pre-operative CT-scan [7 days after surgery]

    Rate of patients who had computed tomography before surgery

  2. Multidisciplinary team meeting [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 [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 [90 days after surgery]

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

  5. Readmission [90 days after surgery]

    Rate of hospital readmissions leakage after resection of colorectal cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut National d'Oncologie Rabat Morocco 10100

Sponsors and Collaborators

  • Institut National d'Oncologie, Morocco

Investigators

  • Principal Investigator: Anass M Majbar, National Institute of Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anass Majbar, Professor of surgery, Institut National d'Oncologie, Morocco
ClinicalTrials.gov Identifier:
NCT04349384
Other Study ID Numbers:
  • SCOD 2
First Posted:
Apr 16, 2020
Last Update Posted:
Apr 16, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anass Majbar, Professor of surgery, Institut National d'Oncologie, Morocco
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 16, 2020