Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

NCT ID: NCT06050447

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-09-01

Brief Summary

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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

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Conditions

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Colorectal Cancer Colon Cancer Rectal Cancer Colorectal Adenocarcinoma Colorectal Neoplasms Malignant Rectal Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with right-sided colon cancer

Tumors located anywhere from the cecum to the proximal transverse colon.

Right hemicolectomy

Intervention Type PROCEDURE

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

Left hemicolectomy

Intervention Type PROCEDURE

Resection of the sigmoid colon is appropriate for patients with tumors located anywhere from the distal transverse colon to the rectosigmoid junction.

Sigmoid colon resection

Intervention Type PROCEDURE

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

Anterior resection of the rectum

Intervention Type PROCEDURE

AR is appropriate for tumors located in rectosigmoid junction and in the proximal rectum

Low anterior resection of the rectum

Intervention Type PROCEDURE

LAR is appropriate for tumors located in the middle and low rectum

Abdominoperineal resection

Intervention Type PROCEDURE

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

Total Colectomy

Intervention Type PROCEDURE

Total abdominal colectomy may be indicated for patients with primary multiple cancer tumors

Interventions

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Right hemicolectomy

Resection of the caecum and ascending colon is appropriate for patients with tumors located anywhere from caecum to the transverse colon

Intervention Type 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.

Intervention Type PROCEDURE

Sigmoid colon resection

Resection of the sigmoid colon is appropriate for patients with tumors located in the sigmoid colon

Intervention Type PROCEDURE

Anterior resection of the rectum

AR is appropriate for tumors located in rectosigmoid junction and in the proximal rectum

Intervention Type PROCEDURE

Low anterior resection of the rectum

LAR is appropriate for tumors located in the middle and low rectum

Intervention Type PROCEDURE

Abdominoperineal resection

APR is appropriate for distal rectal cancers that invade the external sphincter or the levator muscles

Intervention Type PROCEDURE

Total Colectomy

Total abdominal colectomy may be indicated for patients with primary multiple cancer tumors

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center of Endourology "Endocenter"

OTHER

Sponsor Role collaborator

Immanuel Kant Baltic Federal University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mikhail A Agapov, PhD

Role: PRINCIPAL_INVESTIGATOR

Baltic Federal University

Locations

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Baltic Federal University

Kaliningrad, Kaliningrad Oblast, Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Tatiana N Garmanova, PhD

Role: CONTACT

+79773429249

Facility Contacts

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Viktor V Kakotkin, MD

Role: primary

+74012595071

Other Identifiers

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5995465480

Identifier Type: -

Identifier Source: org_study_id

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