NCT04349384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

April 13, 2020

Last Update Submit

April 15, 2020

Conditions

Rectal AdenocarcinomaColon Adenocarcinoma

Keywords

Rectal neoplasmsColon neoplasms

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Pre-operative CT-scan

    7 days after surgery

  • Multidisciplinary team meeting

    7 days after surgery

  • MRI for rectal adenocarcinoma

    7 days after surgery

  • Anastomotic leakage

    90 days after surgery

  • Readmission

    90 days after surgery

Study Arms (2)

Colon adenocarcinoma

Patient who underwent surgical resection for colon adenocarcinoma

Procedure: Colorectal resection

Rectal adenocarcinoma

Patient who underwent surgical resection for rectal adenocarcinoma

Procedure: Colorectal resection

Interventions

Colorectal resectionPROCEDURE

Colon or rectal resection for colorectal adenocarcinoma

Colon adenocarcinomaRectal adenocarcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut National d'Oncologie

Rabat, 10100, Morocco

Location

MeSH Terms

Conditions

Rectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic Diseases

Study Officials

  • Anass M Majbar

    National Institute of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of surgery

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 16, 2020

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 16, 2020

Record last verified: 2020-04

Locations

MO(1)