- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04288284
Emergency Curative Resection of Colorectal Cancer
February 25, 2020 updated by: Mohamed El Messiry, University of Alexandria
Emergency Curative Resection of Colorectal Cancer, Do it With Caution. A Comparative Case Series
The feasibility and efficacy of emergency curative resection of complicated colorectal cancer is still controversial.
This prospective study aim is to assess surgical and oncologic outcomes after emergency compared to elective curative resection of colorectal cancer
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
60 consecutive patients presented with complicated colorectal cancer managed by emergency surgery were included and compared to another 155 consecutive patients admitted during the same period with uncomplicated colorectal cancer managed by elective surgery.
Both groups were compared regarding curative resection rate, early postoperative mortality and morbidity, 3-years tumor recurrence and survival rates.
Study Type
Observational
Enrollment (Actual)
215
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
This study included 60 consecutive patients presented by complicated colorectal cancer treated by emergency surgery at Alexandria University hospital between January 2015 and January 2017 (Group I).
Another 155 patients with uncomplicated colorectal cancer treated by elective surgery during the same period were included (Group II).
Description
Inclusion Criteria:
- All patients presented with Potentially operable colorectal cancer
- No clinical or radiological evidence of metastatic disease
Exclusion Criteria:
- Patients received preoperative chemoradiation
- Patients with clinical or radiological evidence of metastatic disease
- Patients with intraoperative evidence of metastatic disease
- Patients with intraoperative evidence of irresectable disease
- Patients with incomplete follow up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Emergency group
Patients presented to emergency by complicated colorectal cancer ( Obstruction, bleeding or perforation)
|
|
Elective group
Patients presented with uncomplicated colorectal cancer for resection treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequate oncologic resection
Time Frame: histopathological assessment of surgical specimens within 2 weeks postoperative
|
Negative resection margins + adequate lymphadenectomy ( Lymph Nodes retrieved > 12)
|
histopathological assessment of surgical specimens within 2 weeks postoperative
|
early postoperative mortality after curative resection of colorectal cancer
Time Frame: within 90 days after surgery
|
early death due to cause related to surgery
|
within 90 days after surgery
|
early postoperative morbidity after curative resection of colorectal cancer
Time Frame: within 90 days after surgery
|
surgery-related complications
|
within 90 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor recurrence
Time Frame: By the end of the 3 years follow up period
|
either local or distant
|
By the end of the 3 years follow up period
|
Disease free survival
Time Frame: By the end of the 3 years follow up period
|
% of patients survived without recurrence
|
By the end of the 3 years follow up period
|
Overall survival
Time Frame: By the end of the 3 years follow up period
|
% of all patients survived either with or without recurrence
|
By the end of the 3 years follow up period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed Elmessiry, MD, PhD, Ass. Professor of Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ghazi S, Berg E, Lindblom A, Lindforss U; Low-Risk Colorectal Cancer Study Group. Clinicopathological analysis of colorectal cancer: a comparison between emergency and elective surgical cases. World J Surg Oncol. 2013 Jun 11;11:133. doi: 10.1186/1477-7819-11-133.
- Biondo S, Marti-Rague J, Kreisler E, Pares D, Martin A, Navarro M, Pareja L, Jaurrieta E. A prospective study of outcomes of emergency and elective surgeries for complicated colonic cancer. Am J Surg. 2005 Apr;189(4):377-83. doi: 10.1016/j.amjsurg.2005.01.009.
- Kim J, Mittal R, Konyalian V, King J, Stamos MJ, Kumar RR. Outcome analysis of patients undergoing colorectal resection for emergent and elective indications. Am Surg. 2007 Oct;73(10):991-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2015
Primary Completion (ACTUAL)
December 1, 2019
Study Completion (ACTUAL)
February 1, 2020
Study Registration Dates
First Submitted
February 25, 2020
First Submitted That Met QC Criteria
February 25, 2020
First Posted (ACTUAL)
February 28, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 28, 2020
Last Update Submitted That Met QC Criteria
February 25, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0302761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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