Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Patients with right-sided colon cancer Tumors located anywhere from the cecum to the proximal transverse colon. |
Procedure: Right hemicolectomy
Resection of the caecum and ascending colon is appropriate for patients with tumors located anywhere from caecum to the transverse colon
|
Patients with left-sided colon cancer Tumors located anywhere from the distal transverse colon to the rectosigmoid junction |
Procedure: Left hemicolectomy
Resection of the sigmoid colon is appropriate for patients with tumors located anywhere from the distal transverse colon to the rectosigmoid junction.
Procedure: Sigmoid colon resection
Resection of the sigmoid colon is appropriate for patients with tumors located in the sigmoid colon
|
Patients with rectal cancer Tumors located in rectosigmoid junction and in the rectum with/without the external sphincter or the levator muscles invasion |
Procedure: Anterior resection of the rectum
AR is appropriate for tumors located in rectosigmoid junction and in the proximal rectum
Procedure: Low anterior resection of the rectum
LAR is appropriate for tumors located in the middle and low rectum
Procedure: Abdominoperineal resection
APR is appropriate for distal rectal cancers that invade the external sphincter or the levator muscles
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Patients with right- and left-sided colon cancer (primary multiple cancer) Patients with primary multiple cancer tumors |
Procedure: Total Colectomy
Total abdominal colectomy may be indicated for patients with primary multiple cancer tumors
|
Outcome Measures
Primary Outcome Measures
- Anastomotic leakage rate [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
- Mortality rate [3 years after surgery]
the overall mortality after colorectal cancer surgery
Secondary Outcome Measures
- 30-day complication rate [30 days after surgery]
The number of patients with complications after colorectal resection. All complications will be assessed according to the Clavien-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). Grade I - Any deviation from the normal postoperative course without the need for treatment. Grade II - Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III - Requiring surgical, endoscopic or radiological intervention IIIa - Intervention not under general anesthesia IIIb - Intervention under general anesthesia Grade IV - Life-threatening complication requiring IC/ICU-management IVa - single organ dysfunction (including dialysis) IVb - multiorgandysfunction Grade V - Death of a patient
- Recurrence rate [3 years after surgery]
All cases of colorectal cancer recurrence
- Cancer-specific survival [3 years after surgery]
The number of patients survived within 3 years after the diagnosis
- Recurrence-free survival [3 years after surgery]
The number of patients without cancer recurrence within 3 years after surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically proven primary adenocarcinoma of bowel;
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All patients who have indications for surgical treatment of colorectal cancer based on the decision of the oncological council;
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Signed informed consent with agreement to attend all study visits;
Exclusion Criteria:
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Unresectable tumor or contradictions to surgery;
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Indications for chemotherapy or radiation therapy prior to surgery;
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Patient withdrawal from the trial or loss of follow-up;
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Emergent operation;
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Pregnancy.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Baltic Federal University | Kaliningrad | Kaliningrad Region | Russian Federation | 236041 |
Sponsors and Collaborators
- Immanuel Kant Baltic Federal University
- Center of Endourology "Endocenter"
Investigators
- Principal Investigator: Mikhail A Agapov, PhD, Baltic Federal University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5995465480