Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Immanuel Kant Baltic Federal University
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Mortality rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven primary adenocarcinoma of bowel;
- •All patients who have indications for surgical treatment of colorectal cancer based on the decision of the oncological council;
- •Signed informed consent with agreement to attend all study visits;
Exclusion Criteria
- •Unresectable tumor or contradictions to surgery;
- •Indications for chemotherapy or radiation therapy prior to surgery;
- •Patient withdrawal from the trial or loss of follow-up;
- •Emergent operation;
- •Pregnancy.
Outcomes
Primary Outcomes
Mortality rate
Time Frame: 3 years after surgery
the overall mortality after colorectal cancer surgery
Anastomotic leakage rate
Time Frame: 3 months after surgery
Anastomotic leakage rate after colorectal resection. AL is confirmed by one or more of the following conditions: * fecal discharge from the pelvic drainage at any time after surgery * rectovaginal fistula defined as fecal or mucus discharge from the vagina * pelvic sepsis as defined by the collection of pus/ fecal material in the pelvis documented by CT scan * contrast present outside of the anastomosis as seen by X-Ray contrast enema proctography or CT contrast enema proctography
Secondary Outcomes
- Recurrence rate(3 years after surgery)
- 30-day complication rate(30 days after surgery)
- Cancer-specific survival(3 years after surgery)
- Recurrence-free survival(3 years after surgery)