Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Conditions
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Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Adenocarcinoma, Colorectal Neoplasms Malignant, Rectal Adenocarcinoma

Intervention / Treatment
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* Procedure: Right hemicolectomy
* Procedure: Left hemicolectomy
* Procedure: Sigmoid colon resection
* Procedure: Anterior resection of the rectum
* Procedure: Low anterior resection of the rectum
* Procedure: Abdominoperineal resection
* Procedure: Total Colectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with right-sided colon cancer<br>Tumors located anywhere from the cecum to the proximal transverse colon. | Procedure: Right hemicolectomy<br>* Resection of the caecum and ascending colon is appropriate for patients with tumors located anywhere from caecum to the transverse colon<br>|
| Patients with left-sided colon cancer<br>Tumors located anywhere from the distal transverse colon to the rectosigmoid junction | Procedure: Left hemicolectomy<br>* Resection of the sigmoid colon is appropriate for patients with tumors located anywhere from the distal transverse colon to the rectosigmoid junction.<br>Procedure: Sigmoid colon resection<br>* Resection of the sigmoid colon is appropriate for patients with tumors located in the sigmoid colon<br>|
| Patients with rectal cancer<br>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<br>* AR is appropriate for tumors located in rectosigmoid junction and in the proximal rectum<br>Procedure: Low anterior resection of the rectum<br>* LAR is appropriate for tumors located in the middle and low rectum<br>Procedure: Abdominoperineal resection<br>* APR is appropriate for distal rectal cancers that invade the external sphincter or the levator muscles<br>|
| Patients with right- and left-sided colon cancer (primary multiple cancer)<br>Patients with primary multiple cancer tumors | Procedure: Total Colectomy<br>* Total abdominal colectomy may be indicated for patients with primary multiple cancer tumors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leakage rate | 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 | 3 months after surgery | 
| Mortality rate | the overall mortality after colorectal cancer surgery | 3 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day complication rate | 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 | 30 days after surgery | 
| Recurrence rate | All cases of colorectal cancer recurrence | 3 years after surgery | 
| Cancer-specific survival | The number of patients survived within 3 years after the diagnosis | 3 years after surgery | 
| Recurrence-free survival | The number of patients without cancer recurrence within 3 years after surgery | 3 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Rectal cancer, Colon cancer, Colorectal surgery, anastomotic leakage, postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival