Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

September 15, 2023 updated by: Immanuel Kant Baltic Federal University
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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
    • Kaliningrad Region
      • Kaliningrad, Kaliningrad Region, Russian Federation, 236041
        • Recruiting
        • Baltic Federal University
        • Contact:
        • Principal Investigator:
          • Mikhail A Agapov, PhD/MD
        • Sub-Investigator:
          • Viktor V Kakotkin, MD
        • Sub-Investigator:
          • Tatyana N Garmanova, PhD/MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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
3 months after surgery
Mortality rate
Time Frame: 3 years after surgery
the overall mortality after colorectal cancer surgery
3 years after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immanuel Kant Baltic Federal University

Collaborators

Center of Endourology "Endocenter"

Investigators

  • Principal Investigator: Mikhail A Agapov, PhD, Baltic Federal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe