Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Rectal Cancer; Colon Cancer; Colorectal Adenocarcinoma; Rectal Adenocarcinoma; Colorectal Neoplasms Malignant
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Tatiana N Garmanova, PhD; Phone Number: +79773429249; Email: tatianagarmanova@gmail.com

Study Locations

• Russian Federation
  • Kaliningrad Region
    • Kaliningrad, Kaliningrad Region, Russian Federation, 236041
      • Recruiting
      • Baltic Federal University
      • Contact: Viktor V Kakotkin, MD; Phone Number: +74012595071; Email: Vkakotkin@kantiana.ru
      • Principal Investigator: Mikhail A Agapov, PhD/MD
      • Sub-Investigator: Viktor V Kakotkin, MD
      • Sub-Investigator: Tatyana N Garmanova, PhD/MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months after surgery
Mortality rate	the overall mortality after colorectal cancer surgery	3 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days after surgery
Recurrence rate	All cases of colorectal cancer recurrence	3 years after surgery
Cancer-specific survival	The number of patients survived within 3 years after the diagnosis	3 years after surgery
Recurrence-free survival	The number of patients without cancer recurrence within 3 years after surgery	3 years after surgery

Collaborators and Investigators

• Sponsor: Immanuel Kant Baltic Federal University
• Collaborators: Center of Endourology "Endocenter"
• Investigators: Principal Investigator: Mikhail A Agapov, PhD, Baltic Federal University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal cancer; Rectal cancer; Colorectal surgery; Colon cancer; recurrence rate; postoperative complications; anastomotic leakage; cancer-specific survival; recurrence-free survival
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Colorectal Neoplasms; Adenocarcinoma; Rectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 5995465480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No