Colorectal Cancer Clinical Trial
Official title:
Emergency Curative Resection of Colorectal Cancer, Do it With Caution. A Comparative Case Series
NCT number | NCT04288284 |
Other study ID # | 0302761 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | February 2020 |
Verified date | February 2020 |
Source | University of Alexandria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 215 |
Est. completion date | February 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Alexandria |
Biondo S, Martí-Ragué J, Kreisler E, Parés D, Martín 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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adequate oncologic resection | Negative resection margins + adequate lymphadenectomy ( Lymph Nodes retrieved > 12) | histopathological assessment of surgical specimens within 2 weeks postoperative | |
Primary | early postoperative mortality after curative resection of colorectal cancer | early death due to cause related to surgery | within 90 days after surgery | |
Primary | early postoperative morbidity after curative resection of colorectal cancer | surgery-related complications | within 90 days after surgery | |
Secondary | Tumor recurrence | either local or distant | By the end of the 3 years follow up period | |
Secondary | Disease free survival | % of patients survived without recurrence | By the end of the 3 years follow up period | |
Secondary | Overall survival | % of all patients survived either with or without recurrence | By the end of the 3 years follow up period |
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