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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2020
Source University of Alexandria
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Curative resection of colorectal cancer


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Alexandria

References & Publications (3)

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

Outcome

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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