Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050447
• Other study ID #: 5995465480
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: September 2023
• Source: Immanuel Kant Baltic Federal University
• Contact: Tatiana N Garmanova, PhD
• Phone: +79773429249
• Email: tatianagarmanova[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Colon Cancer
• Colonic Neoplasms
• Colorectal Adenocarcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Neoplasms Malignant
• Neoplasms
• Rectal Adenocarcinoma
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Right hemicolectomy
Resection of the caecum and ascending colon is appropriate for patients with tumors located anywhere from caecum to the transverse colon
• Left hemicolectomy
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
Resection of the sigmoid colon is appropriate for patients with tumors located in the sigmoid colon
• Anterior resection of the rectum
AR is appropriate for tumors located in rectosigmoid junction and in the proximal rectum
• Low anterior resection of the rectum
LAR is appropriate for tumors located in the middle and low rectum
• Abdominoperineal resection
APR is appropriate for distal rectal cancers that invade the external sphincter or the levator muscles
• Total Colectomy
Total abdominal colectomy may be indicated for patients with primary multiple cancer tumors

Locations

Country	Name	City	State
Russian Federation	Baltic Federal University	Kaliningrad	Kaliningrad Region

Sponsors (2)

Lead Sponsor	Collaborator
Immanuel Kant Baltic Federal University	Center of Endourology "Endocenter"

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mortality rate	the overall mortality after colorectal cancer surgery	3 years after surgery
Secondary	30-day complication rate	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
Secondary	Recurrence rate	All cases of colorectal cancer recurrence	3 years after surgery
Secondary	Cancer-specific survival	The number of patients survived within 3 years after the diagnosis	3 years after surgery
Secondary	Recurrence-free survival	The number of patients without cancer recurrence within 3 years after surgery	3 years after surgery