Actively Recruiting
Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Led by Immanuel Kant Baltic Federal University · Updated on 2023-09-22
1200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
Immanuel Kant Baltic Federal University
Lead Sponsor
C
Center of Endourology "Endocenter"
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are examining how the location of colorectal cancer tumors affects outcomes after surgery. This study looks at risks such as death, leakage at the surgical connection, early and late complications, cancer recurrence, and survival rates specific to cancer over several years after surgery. The study focuses on patients with colorectal cancer undergoing surgery and aims to understand how tumor location impacts treatment results. Participants receive different types of surgical procedures depending on where their tumor is located. These include removal of parts of the colon or rectum, such as right or left hemicolectomy, sigmoid colon resection, anterior or low anterior resection of the rectum, abdominoperineal resection, or total colectomy for multiple tumors. Each surgery is selected based on the tumor's position from the cecum to the rectum or if multiple primary tumors are present. Throughout the study, researchers will monitor participants for surgical complications within 30 days, leakage rates at the surgical join after 3 months, and mortality along with cancer recurrence and survival up to 3 years post-surgery. Patients will attend study visits to provide data for these outcomes, including cancer-specific and recurrence-free survival. The study is observational and follows patients over this period to collect detailed safety and effectiveness information about colorectal cancer surgeries.
CONDITIONS
Brief Title
Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven primary adenocarcinoma of bowel
- Patients with indications for surgical treatment of colorectal cancer based on oncological council decision
- Signed informed consent with agreement to attend all study visits
You will not qualify if you...
- 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
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days after surgery
Participants undergo surgery appropriate to their tumor location to remove colorectal cancer, followed by immediate post-operative care.
Approximately 1 hospital stay and follow-up visits during the first 30 days
Duration - Up to 3 years after surgery
Participants are monitored for complications, recurrence, and survival outcomes after surgery.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Baltic Federal University
Kaliningrad, Kaliningrad Oblast, Russia, 236041
Actively Recruiting
Research Team
T
Tatiana N Garmanova, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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