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

• 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

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