Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Sponsor

Immanuel Kant Baltic Federal University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06050447

Collaborator

Center of Endourology "Endocenter" (Other)

1,200

Enrollment

Location

Anticipated Duration (Months)

33.3

Patients Per Site Per Month

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
Colorectal Cancer Colon Cancer Rectal Cancer Colorectal Adenocarcinoma Colorectal Neoplasms Malignant Rectal Adenocarcinoma	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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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
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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;