Colon Cancer, Colorectal Adenocarcinoma, Colorectal Cancer, Colorectal Neoplasms Malignant, Rectal Adenocarcinoma, Rectal Cancer
Conditions
Keywords
Colorectal cancer, Rectal cancer, Colon cancer, Colorectal surgery, anastomotic leakage, postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival
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.
Interventions
PROCEDURERight hemicolectomy
Resection of the caecum and ascending colon is appropriate for patients with tumors located anywhere from caecum to the transverse colon
PROCEDURELeft hemicolectomy
Resection of the sigmoid colon is appropriate for patients with tumors located anywhere from the distal transverse colon to the rectosigmoid junction.
PROCEDURESigmoid colon resection
Resection of the sigmoid colon is appropriate for patients with tumors located in the sigmoid colon
PROCEDUREAnterior resection of the rectum
AR is appropriate for tumors located in rectosigmoid junction and in the proximal rectum
PROCEDURELow anterior resection of the rectum
LAR is appropriate for tumors located in the middle and low rectum
PROCEDUREAbdominoperineal resection
APR is appropriate for distal rectal cancers that invade the external sphincter or the levator muscles
PROCEDURETotal Colectomy
Total abdominal colectomy may be indicated for patients with primary multiple cancer tumors
Sponsors
Center of Endourology Endocenter
Immanuel Kant Baltic Federal University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Russia
Contacts
Primary ContactTatiana N Garmanova, PhD
Outcome results
None listed