Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Recruiting

• Conditions: Colon Cancer; Rectal Cancer; Colorectal Neoplasms Malignant; Rectal Adenocarcinoma; Colorectal Cancer; Colorectal Adenocarcinoma
• Interventions: Procedure: Anterior resection of the rectum; Procedure: Right hemicolectomy; Procedure: Left hemicolectomy; Procedure: Total Colectomy; Procedure: Sigmoid colon resection; Procedure: Low anterior resection of the rectum; Procedure: Abdominoperineal resection

• Registration Number: NCT06050447
• Lead Sponsor: Immanuel Kant Baltic Federal University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-28
• Status Verified: 2023-09
• Study Start: 2023-09-01
• Study First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with left-sided colon cancer	Sigmoid colon resection	Tumors located anywhere from the distal transverse colon to the rectosigmoid junction
Patients with rectal cancer	Anterior resection of the rectum	Tumors located in rectosigmoid junction and in the rectum with/without the external sphincter or the levator muscles invasion
Patients with rectal cancer	Abdominoperineal resection	Tumors located in rectosigmoid junction and in the rectum with/without the external sphincter or the levator muscles invasion
Patients with right-sided colon cancer	Right hemicolectomy	Tumors located anywhere from the cecum to the proximal transverse colon.
Patients with rectal cancer	Low anterior resection of the rectum	Tumors located in rectosigmoid junction and in the rectum with/without the external sphincter or the levator muscles invasion
Patients with left-sided colon cancer	Left hemicolectomy	Tumors located anywhere from the distal transverse colon to the rectosigmoid junction
Patients with right- and left-sided colon cancer (primary multiple cancer)	Total Colectomy	Patients with primary multiple cancer tumors

Primary Outcome Measures

Name	Time	Method
Mortality rate	3 years after surgery	the overall mortality after colorectal cancer surgery
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

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	3 years after surgery	All cases of colorectal cancer recurrence
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
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

Trial Locations

Locations (1)

Baltic Federal University; 🇷🇺 Kaliningrad, Kaliningrad Region, Russian Federation