About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up
Trial design
Cohort
Prospective
Treatments tested in this trial
Right hemicolectomy
Procedure/SurgeryResection of the caecum and ascending colon is appropriate for patients with tumors located anywhere from caecum to the transverse colon
Left hemicolectomy
Procedure/SurgeryResection of the sigmoid colon is appropriate for patients with tumors located anywhere from the distal transverse colon to the rectosigmoid junction.
Sigmoid colon resection
Procedure/SurgeryResection of the sigmoid colon is appropriate for patients with tumors located in the sigmoid colon
Anterior resection of the rectum
Procedure/SurgeryAR is appropriate for tumors located in rectosigmoid junction and in the proximal rectum
Low anterior resection of the rectum
Procedure/SurgeryLAR is appropriate for tumors located in the middle and low rectum
Abdominoperineal resection
Procedure/SurgeryAPR is appropriate for distal rectal cancers that invade the external sphincter or the levator muscles
Total Colectomy
Procedure/SurgeryTotal abdominal colectomy may be indicated for patients with primary multiple cancer tumors
Treatment groups
Trial outcomes
Primary outcomes
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
Mortality rate
the overall mortality after colorectal cancer surgery
Secondary outcomes
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
Recurrence rate
All cases of colorectal cancer recurrence
Cancer-specific survival
The number of patients survived within 3 years after the diagnosis
Recurrence-free survival
The number of patients without cancer recurrence within 3 years after surgery
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Immanuel Kant Baltic Federal University
Lead sponsor
Center of Endourology "Endocenter"
Collaborator