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Recruiting NCT06050447

Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Observational Colorectal Cancer Colon Cancer Rectal Cancer Colorectal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Right hemicolectomy, Left hemicolectomy, Sigmoid colon resection, Anterior resection of the rectum.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Right hemicolectomy
    Resection of the caecum and ascending colon is appropriate for patients with tumors located anywhere from caecum to the transverse colon
  • 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
  • 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
  • Procedure Total Colectomy
    Total abdominal colectomy may be indicated for patients with primary multiple cancer tumors

Primary outcome measures

  • Anastomotic leakage rate [Time frame: 3 months after surgery]
  • Mortality rate [Time frame: 3 years after surgery]
Secondary outcome measures (4)
  • 30-day complication rate [Time frame: 30 days after surgery]
  • Recurrence rate [Time frame: 3 years after surgery]
  • Cancer-specific survival [Time frame: 3 years after surgery]
  • Recurrence-free survival [Time frame: 3 years after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Russia · 1 center
  • Baltic Federal University — Kaliningrad

Identifiers

NCT: NCT06050447 · 5995465480

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗