Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

NCT06050447 | Recruiting DMC

• 1 other identifier: 5995465480
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Colorectal cancer; Rectal cancer; Colon cancer; Colorectal surgery; anastomotic leakage; postoperative complications; recurrence rate; cancer-specific survival; recurrence-free survival

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 30-day complication rate

  30 days after surgery

• Recurrence rate

  3 years after surgery

• Cancer-specific survival

  3 years after surgery

• Recurrence-free survival

  3 years after surgery

Study Arms (4)

Patients with right-sided colon cancer

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

Procedure: Right hemicolectomy

Patients with left-sided colon cancer

Tumors located anywhere from the distal transverse colon to the rectosigmoid junction

Procedure: Left hemicolectomy; Procedure: Sigmoid colon resection

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; Procedure: Low anterior resection of the rectum; Procedure: Abdominoperineal resection

Patients with right- and left-sided colon cancer (primary multiple cancer)

Patients with primary multiple cancer tumors

Procedure: Total Colectomy

Interventions

Right hemicolectomy PROCEDURE

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

Patients with right-sided colon cancer

Left hemicolectomy PROCEDURE

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

Patients with left-sided colon cancer

Sigmoid colon resection PROCEDURE

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

Patients with left-sided colon cancer

Anterior resection of the rectum PROCEDURE

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

Patients with rectal cancer

Low anterior resection of the rectum PROCEDURE

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

Patients with rectal cancer

Abdominoperineal resection PROCEDURE

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

Patients with rectal cancer

Total Colectomy PROCEDURE

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

Patients with right- and left-sided colon cancer (primary multiple cancer)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immanuel Kant Baltic Federal University: lead
• Center of Endourology "Endocenter": collaborator

Study Sites (1)

Baltic Federal University

Kaliningrad, Kaliningrad Oblast, 236041, Russia

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Anastomotic Leak; Postoperative Complications

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mikhail A Agapov, PhD

  Baltic Federal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana N Garmanova, PhD

CONTACT

+79773429249; tatianagarmanova@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 22, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)